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Effectiveness of Surgical and Postsurgical Interventions for Carpal Tunnel Syndrome—A Systematic Review
Accepted Manuscript The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A Systematic Review Bionka MA. Huisstede, PhD, Janneke van den Brink, PT, MSc, Manon S. Randsdorp, MD, Sven JG. Geelen, BSc, Bart W. Koes, PhD PII:
S0003-9993(17)30372-6
DOI:
10.1016/j.apmr.2017.04.024
Reference:
YAPMR 56901
To appear in:
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION
Received Date: 15 January 2017 Revised Date:
17 April 2017
Accepted Date: 27 April 2017
Please cite this article as: Huisstede BM, van den Brink J, Randsdorp MS, Geelen SJ, Koes BW, The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A Systematic Review, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2017), doi: 10.1016/ j.apmr.2017.04.024. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Running head: Effectiveness (post)surgical treatments for CTS
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The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A
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Systematic Review
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Bionka MA Huisstede
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Geelen BSc, Bart W Koes PhD
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University Medical Center Utrecht, Rudolf Magnus Institute of Neurosciences, Department of Rehabilitation, Physical Therapy Science & Sports 2 Erasmus MC, Department of General Practice, Rotterdam, The Netherlands
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This material has not been presented elsewhere
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No financial support was provided
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PhD, Janneke van den Brink PT, MSc, Manon S Randsdorp MD, Sven JG
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Address for correspondence:
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Bionka M.A. Huisstede, PhD
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Rehabilitation, Physical Therapy Science & Sports, Room, Building W01.121
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University Medical Center Utrecht
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P.O. Box 85500
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3508 GA Utrecht, The Netherlands
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The Netherlands
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Tel: +31-88-7560945
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E-mail: [email protected]
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The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A
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Systematic Review
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Objective: To present an evidence-based overview of the effectiveness of surgical and postsurgical
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interventions for carpal tunnel syndrome (CTS).
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Data Sources: The Cochrane Library, PubMed, EMBASE, CINAHL and PEDro were searched for
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relevant systematic reviews and randomized controlled trials (RCTs) up to April 8th 2016.
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Data Selection and Extraction: Two reviewers independently selected the studies, extracted the
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data, and assessed the methodological quality.
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Data Synthesis and Results: A best-evidence synthesis was performed to summarize the results.
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Four systematic reviews and 33 RCTs were included. Surgery versus non-surgical interventions,
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timing of surgery, various surgical techniques and post-operative interventions were studied.
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Corticosteroid injection was more effective than surgery (strong evidence, short-term). Surgery was
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more effective than splinting or anti-inflammatory drugs plus handtherapy (moderate evidence, mid-
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and longterm). Manual therapy was more effective than surgical treatment (moderate evidence, short
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and midterm). Within surgery, corticosteroid irrigation of the median nerve before skin closure as
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additive to CTS-release or the direct vision plus tunnelling technique were more effective than
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standard open CTS-release (moderate evidence, short term). Furthermore, short- was more effective
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than long- bulky dressing and a sensory retraining program was more effective than no program after
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surgery (moderate evidence, shortterm). For all other interventions only conflicting, limited, or no
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evidence was found.
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Conclusions: Surgical treatment seems to be more effective than splinting, anti-inflammatory drugs
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plus hand therapy the in short, mid and/or long term to treat CTS. Although there is strong evidence
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that a local corticosteroid injection is more effective than surgery in shortterm and moderate evidence
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that manual therapy is more effective than surgery in short and midterm. There is no unequivocal
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evidence that suggests one surgical treatment is more effective than the other. Postsurgical, a short-
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favored a long-duration bulky dressing and a sensory retraining program seems to be more effective
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than no program in shortterm. More research regarding the optimal timing of surgery for CTS is
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needed.
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Keywords: Carpal tunnel syndrome; Orthopaedic and plastic surgery; Rehabilitation; Review
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[publication type]; Treatment outcome.
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List of Abbreviations
CANS, complaints of the arm, neck and/or shoulder
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CI, confidence interval
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CTS, carpal tunnel syndrome
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MD, mean difference
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OR, odds ratio
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RCT, randomized controlled trial
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RR, relative risk
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VAS, visual analog scale
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WMD, weighted mean differences
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SMD, standardized mean differences
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Carpal tunnel syndrome (CTS), the most common entrapment neuropathy, is one of the 6 specific
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neuropathies mentioned in the complaints of the arm, neck and/or shoulder (CANS) model.
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report a history of nocturnal pins and needles, numbness and/or pain in the median nerve innervated
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area of the fingers, consequently often resulting in night waking.
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Patients
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CTS can be treated conservatively without surgery. Surgery may be indicated when conservative
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treatment fails. European clinical experts agreed that CTS should be treated with instructions plus
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splinting, corticosteroid injections, splinting plus corticosteroid injections, or surgery. The Cochrane
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review of Verdugo et al reported that surgical treatment of carpal tunnel syndrome relieves
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symptoms significantly better than splinting. The AAOS guideline reported that surgical treatment of
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carpal tunnel syndrome should have a greater treatment benefit at 6 and 12 months as compared to
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splinting, NSAIDs/therapy and a single steroid injection. The basic principle of CTS surgery is to
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increase the volume of the carpal tunnel temporarily by dividing the transverse carpal ligament in order
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to release the pressure on the median nerve. Two surgical approaches are commonly used: open
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and endoscopic treatment.
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complications for endoscopic carpal tunnel release compared to open carpal tunnel release, but
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reported no difference in the rates of major complications. Over time, several surgical techniques were
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introduced to increase the success rate of CTS-surgery by reducing postoperative pain, limited
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function and shortening recovery time, for example by adding tenosynovectomy or transverse carpal
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ligament reconstruction.
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evidence supporting the need for replacement of standard open carpal tunnel release by existing
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alternative surgical procedure. Rehabilitation treatments are believed to speed up recovery and
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manage pain or symptoms from the surgery itself. However, the Cochrane Review of Peters et al
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reported limited evidence of the various types of rehabilitation treatment studied (immobilisation,
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dressing, exercise, cold and ice therapy, different types of hand rehabilitation, laser therapy, electrical
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treatments, scar desensitisation, and arnica). Since the publication of the Cochrane reviews on this
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topic, several randomised clinical trials (RCTs) have been published and we were wondering whether
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the conclusions of the Cochrane reviews would remain the same or needed modification. This review
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The Cochrane review of Scholten et al
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reported that there is no strong
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The Cochrane review of Vasiliadis et al reported fewer minor
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presents an overview of the effectiveness of surgical and postsurgical treatments for CTS. This
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concerns an update of our previous systematic review on this topic.
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METHODS
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A search of relevant systematic reviews on CTS was performed in the Cochrane Library. In addition,
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relevant review publications and RCTs in PubMed, EMBASE, CINAHL and PEDro were searched (1)
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for interventions included in the systematic reviews from the date of the search strategy of the review
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up to April 8th 2016 (ie, recent RCTs) and (2) from the beginning of the database up to April 8th 2016
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(ie, additional RCTs).
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103 Inclusion Criteria
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Systematic reviews and/or RCTs were considered eligible for inclusion if they fulfilled all of the
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following criteria: 1) the study included patients with CTS, (2) CTS was not caused by an acute trauma
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or any systemic disease (such as osteoarthritis, rheumatoid arthritis, diabetes mellitus, or other
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connective tissue disease) as described in the definition of Complaints of the Arm, Neck and/or
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Shoulder (CANS), (3) an intervention for treating the disorder was evaluated and (4) results on pain,
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function, or recovery were reported. There were no language restrictions.
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Studies on the effectiveness of analgesics given pre-surgery, during surgery or directly postsurgery
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and in which the effect of these analgesics on pain as a result of the surgery was studied are excluded
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from this review. Moreover, studies reporting on the effect of sutures were excluded.
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Study Selection
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Two reviewers (B.M.H./T.F. and M.S.R. /S.J.G.G.) independently applied the inclusion criteria to select
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potential relevant studies from the title and abstracts of the references retrieved by the literature
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search. A consensus method was used to solve any disagreements concerning inclusion of studies,
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and a third reviewer (B.K.) was consulted if disagreement persisted.
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Relevant articles are categorized under 3 headers: Systematic reviews, Recent RCTs and Additional
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RCTs. The header "Systematic reviews" describes all Cochrane and Cochrane-based systematic
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reviews. The header "Recent RCTs" covers all RCTs published from the final date of the search
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strategy that the systematic review covered. Finally, the header "Additional RCTs" describes all RCTs
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concerning interventions that have not yet been described in a systematic review
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127 Data extraction
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Two authors (M.S.R./J.B. and B.M.H./S.J.G.G.) independently extracted the data. A consensus
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procedure was used to solve any disagreement between the authors.
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The follow-up time was categorized into short term (0-3mo), midterm (4-6mo) and long term (> 6mo).
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Methodological quality assessment
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Two reviewers independently extracted data and assessed the methodological quality (list of Furlan et
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al , appendix 1).
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135 Data synthesis
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If a quantitative analysis of the studies was not possible because of diverse outcome measures and
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other clinical heterogeneity, a meta-analysis was not performed. A best-evidence syntheses was used
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to summarize the results (table 1).
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supplementary file 1.’
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A detailed description of the method can be found in
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RESULTS
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Characteristics of the Included Studies
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Initially, we identified 563 systematic reviews (the Cochrane Library: 16, Pubmed: 263, EMBASE: 224,
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CINHAL: 27, PEDro: 33) and 2681 RCTs (697 from PubMed, 1718 from EMBASE, 156 from CINAHL,
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110 from PEDro). Finally, 4 Cochrane reviews and 33 RCTs (PubMed: 27, EMBASE: 6, PEDro: 0,
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CINAHL: 0) were included in our systematic review, figure 1. A detailed description of inclusion and
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exclusion of the selected reviews is described in supplementary file 2.
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The characteristics of the included studies are reported in appendix 1 (systematic reviews), appendix
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2 (recent RCTs) and appendix 3 (additional RCTs).
153 Methodological Quality of the Included Studies
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The results of the methodological quality assessment of the 33 included recent and additional RCTs
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are presented in table 2. The methodological quality assessments used in the Cochrane reviews of
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Vasiliadis et al , Scholten et al , Verdugo et al and Peters et al are described in table 3-6
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respectively.
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57 (60%) of low-quality.
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Of the 95 RCTs identified in our systematic review 38 (40%) were of high-quality,
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Evidence for the effectiveness of (post) surgical treatment of CTS can be found in table 7 and 8.
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1. Surgical Versus Nonsurgical Treatment
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Systematic review. The Cochrane review of Verdugo et al examined surgical versus nonsurgical
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treatment of which 4 RCTs (n=349) were included. One low-quality RCT
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compared surgical treatment with splinting (a splint for 1-month and a night splint for at least 6weeks,
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respectively). At 3- and 6-months follow-up, in the high-quality RCT, significantly better results were
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reported on clinical improvement in favor of surgery compared with splinting (RR=1.38, 95% CI, 1.08-
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1.75, and RR=1.29, 95% CI, 1.08-1.55, respectively). At 1-year follow-up, the pooled estimate with
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regard to clinical improvement showed that surgical treatment of CTS relieves symptoms significantly
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better than splinting (RR=1.27; 95% CI, 1.05 to 1.53).
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The other 2 high-quality RCTs , included in the Cochrane review of Verdugo et al compared
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surgery to steroid injection. Ly-Pen et al found significantly better results in favor of corticosteroid
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injections versus surgical decompression on improvement in clinical symptoms at 3-months follow-up
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(RR=.66; 95% CI, .49-.90). At 6- and 12-months follow-up, no significant results were found between
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the groups on the same outcome measurements. Hui et al
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favor of surgery on the outcome improvement in clinical symptoms (RR=2.18; 95% CI, 1.39-3.42) at 3-
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months follow-up. Clinical improvement in grip strength was not significant at 20-weeks follow-up.
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and 1 high-quality RCT
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reported significantly better results in
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Recent RCTs. Six recent RCTs
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carpal tunnel decompression with nonsurgical therapy. Four of these RCTs
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injection with open carpal tunnel release: Ly-pen et al
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high-quality), Andreu et al
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performed an additional analysis of the before mentioned study included in the review of Verdugo et
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al with an extended follow-up of 2-years,
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At 24-months follow-up, Ly-Pen et al reported significant differences on nocturnal paraesthesias
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(P<.001) and self-perceived functional impairment (P=.008) in favor of surgery versus corticosteroid
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injections and no significant differences on diurnal pain.
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At 12-weeks follow-up Ismatullah et al found significant differences in favor of open carpal tunnel
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release versus local steroid injection (P=.000) on the Global Symptom score.
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Andreu et al
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(P=.008 and P=.018) and nocturnal paraesthesias (P=.041 and P=.002) at 3- and 12-months follow-
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up, but not at 6-months.
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Ucan et al
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should be worn 24 hours a day for 3-months. The second group also received the splint but was first
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injected with a local steroid. The third group was treated surgical with an open carpal tunnel release.
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At 3-months of follow-up, no significant changes were found. At 6-months of follow-up, significant
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results on the symptom severity score were found in favor of the third group (P=.004) and on the
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function capacity scale (P=.03).
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Jarvik et al , (n=116, high-quality) compared surgical treatment including open or endoscopic carpal
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tunnel decompression with a combination of interventions including: Ibuprofen, hand therapy for 6
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weeks in 6 sessions and ultrasound therapy at 6-weeks follow-up if there was no improvement after
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hand therapy. Significant differences between the groups were found in favor of surgery on the Carpal
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Tunnel Syndrome Assessment Questionnaire on function (MD=.46; 95% CI, .20-.72) and symptoms
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(MD=.42; 95% CI, .07-.77) at 6-months follow-up. Significant results were also found at 12-months
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follow-up (function: MD=.40, 95% CI, .11-.70; symptoms: MD=.34, 95% CI, .02-.65). No significant
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differences were found on pain intensity at 6-months and 1-year follow-up.
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Penas et al (n=120, high-quality) compared manual therapy with carpal tunnel release (open and
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endoscopic). Significant differences were found on mean hand pain, worst hand pain, and the
compared surgical treatment including open or endoscopic
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compared local steroid 36
(n=163, high-quality), Ismatullah et al
(n=40,
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(n=163, low-quality) and Ucan et al (n=57, low-quality). Ly-pen et al 30
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reported significant differences for functional impairment (P=.003 and P=.014), pain
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up. No significant difference was found on the symptom severity scale at 3-months follow-up. The
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significant difference in favor of manual therapy on worst hand pain remained at 6-months (no P-value
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given). No significant differences between groups were found at 12-months follow-up.
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In conclusion, there is moderate evidence that surgical treatment is more effective than splinting in the
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midterm and long term, and there is conflicting evidence in the short term. We found strong evidence
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for the effectiveness of steroid injections compared with surgery in the short term, no evidence in the
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midterm and limited evidence in favor of surgery in the long term. Furthermore, there is moderate
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evidence that surgical treatment is more effective than nonsurgical therapy using non-steroidal anti-
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inflammatory drugs plus hand therapy (plus ultrasound in cases not responding to hand therapy) in the
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midterm and long term. In contrast, moderate evidence was found in favor of manual therapy in
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comparison with surgical treatment in the short term and midterm. In the long term, there is no
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evidence for the effectiveness in favor of one of these treatment options.
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2. Timing of surgery
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Additional RCTs. One low-quality RCT
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delayed (>6-months after diagnosis) endoscopic carpal tunnel release in patients with moderately
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severe CTS. Chandra et al
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measures: general improvement, nocturnal awakening, severity of most important symptoms, patient
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satisfaction, use of pain medication, the symptom severity scale and the functional status scale which
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was used to make comparisons between groups. After at least 6-months follow up, a significant
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difference was found on the clinical score in favor of the early surgery group (P<.001).
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There is limited evidence for the effectiveness of early surgery (<1 week after diagnosis), compared
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with delayed (>6-months after diagnosis) surgery in the midterm and long term.
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3. Various Surgical Techniques
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Two Cochrane reviews
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surgical techniques. The Cochrane review by Vasiliadis et al
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endoscopic carpal tunnel release with any other type of surgical intervention for CTS (n=2586). The
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Cochrane review by Scholten reported on studies comparing various surgical techniques for CTS.
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, 25 recent RCTs and 1 additional RCT were found that dealt with various 14
reported on studies comparing
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Eight studies comparing open carpal tunnel release with any other surgical intervention were included
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in our review (n=553).
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Endoscopic Versus Standard Open Carpal Tunnel Release
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Systematic review. Two high-quality studies
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included in the Cochrane review of Vasiliadis et al
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carpal tunnel release. Ten studies
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Significant results were found on pain scores in favor of endoscopic carpal tunnel release versus
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standard open carpal tunnel release (two studies
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for grip strength (five studies
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carpal tunnel release. No significant differences were found on overall improvement, the symptom
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severity scale, the functional status scale, pain, numbness and recurrence of symptoms. In the mid
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and long term (>3-months) a significant difference was found on grip strength in favor of endoscopic
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versus standard open carpal tunnel release (two studies
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.56 to 1.71), but no significant differences were found on overall improvement, the symptom severity
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scale, the functional status scale, pain, numbness and recurrence of symptoms.
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Recent RCTs. In total three high-quality
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The high-quality study of Atroshi et al
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years) of the study of Atroshi et al
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Vasiliadis et al . No significant differences were found between two-portal endoscopic and open
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carpal tunnel release on the symptom severity scale and the function severity scale at 12.8-year
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follow-up. Gumustas et al
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endoscopic and open carpal tunnel release on the functional status scale and the symptom severity
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scale at 6-months follow-up.
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Ejiri et al
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pinch strength (P=.01) in favor of one-portal-endoscopic versus open carpal tunnel release at 4-weeks
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follow-up. This difference did not sustain at 12-weeks follow-up. Sensibility tests were not significant at
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4- and 12-weeks follow-up.
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Michelotti et al , (n=50, low-quality) and Aslani et al
and 21 low-quality RCTs
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(total n=2209)
reported on endoscopic versus standard open
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short term, SMD= -.41; 95% CI, -.65 to -.18) and
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reported results in the short term (≤3-months).
short term, SMD=.40; 95%CI, .10 to .71) in favor of endoscopic
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were found.
(n=128) concerned a long term follow-up (mean±SD, 12.8±1.2
which was previously included in the Cochrane review of
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mid and long term, SMD= 1.13; 95% CI,
and three low-quality recent RCTs
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(n=41, high-quality) found no significant differences between two-portal-
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(n=101, high-quality) reported significant differences on grip strength (P=.04) and side
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(n=96, low-quality) reported no significant
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differences between two-and-one-portal-endoscopic and open carpal tunnel release for outcomes on
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pain, function and recovery in respectively 4-weeks/4-months and 12-weeks/24-weeks follow-up.
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Zhang et al (n=213, low-quality) compared subneural reconstruction of the transverse carpal
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ligament (group 1) with open carpal tunnel release (group 2) and two-portal-endoscopic carpal tunnel
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release (group 3). On the functional status scale and pinch grip, significant differences were found
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between group 2 and 3 (P=.045, P=.007) in favor of group 3 at 3-months follow-up, but not at 6-,12-
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and 24-months follow-up. The Michigan Hand Outcome showed significant differences between group
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2 and 3 in favor of group 3 at 12- and 24-months follow-up (P=.006, P=.001). No significant
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differences between group 2 and 3 were found on the symptom severity scale, cylindrical grip strength
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and lateral grip strength at 3-,6-,12- and 24-months follow-up.
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Thus, we found conflicting evidence for the effectiveness of endoscopic compared with standard open
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carpal tunnel release in the short, mid and, long term.
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Endoscopic Versus Miniopen Carpal Tunnel Release
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Systematic review. In total 5 low-quality studies
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review of Vasiliadis et al , reported on endoscopic versus miniopen carpal tunnel release, of these
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three RCTs
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the short term (≤3-months). A significant difference was found on the pain assessed on non-
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continuous dichotomous scales in favor of endoscopic carpal tunnel release compared with standard
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open carpal tunnel release (one study short term, RR= 2.00; 95% CI, 1.01 to -3.95). No significant
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differences were found on overall improvement, the symptom severity scale, the functional status
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scale, pain, grip strength, and recurrence of symptoms in the short term, midterm and long term.
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Recent RCTs. The high-quality RCT of Kang et al
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between one-portal-endoscopic and miniopen carpal tunnel release on the symptom severity scale
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(P=.774), the functional status scale (P=.832) and the Disabilities of the Arm, Shoulder and Hand
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(P=.978) at 3-months follow-up.
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Larsen et al , (n=90, low-quality) reported a significant difference in favor of one-portal-endoscopic
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versus miniopen carpal tunnel release on range of motion at 3-weeks follow-up, but not at 6-, 12- and
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24-weeks follow-up. At 3- and 6-weeks follow-up, a significant difference in favor of one-portal-
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(total n=377), included in the Cochrane
reported results on pain, function or recovery. Two studies
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reported results for
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(n=104) showed no significant difference
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endoscopic release was found on grip strength (no P value given), but not at 12- and 24-weeks follow-
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up.
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We found conflicting evidence that endoscopic carpal tunnel release is more effective in comparison
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with miniopen carpal tunnel release in the short term and no evidence in favor of one of these
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treatments in the mid and long term.
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Endoscopic One or Two Portal Versus Open or Miniopen Carpal Tunnel Release
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Systematic review. In total, 1 high-quality study and 15 low-quality studies
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reported on one-portal endoscopic versus open or miniopen carpal tunnel release and 1 high-quality
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study and 8 low-quality studies
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miniopen carpal tunnel release, all included in the Cochrane review of Vasiliadis et al , Eight
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studies
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assessed on a non-continuous dichotomous scales favored one-portal carpal tunnel release over
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standard open carpal tunnel release (two studies
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grip strength in favor of two-portal carpal tunnel release versus standard open carpal tunnel release
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(three studies
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difference on grip strength (>3-months) was found in favor of one-portal versus standard open carpal
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tunnel release (one study mid-term and long term, SMD= 1.28; 95% CI, .60 to 1.96).
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Recent RCTs. The same RCTs mentioned in “Endoscopic Carpal Tunnel Release Versus Standard
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Open Carpal Tunnel Release” and “Endoscopic Carpal Tunnel Release Versus Miniopen Carpal
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Tunnel Release” are included.
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RCTs
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open or miniopen carpal tunnel release (one-portal: two high-quality RCTs
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RCTs
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In conclusion, we found conflicting evidence for the effectiveness of one-portal endoscopic compared
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with open carpal tunnel release in the short and midterm and no evidence in the long term. Further, we
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found conflicting evidence for the effectiveness of two-portal endoscopic versus open carpal tunnel
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release in the short, mid-, and, long term. No studies reported on one versus two-portal carpal tunnel
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release.
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reported short term (≤3-months) results. Significant results were found on pain
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and 4 low-quality RCTs
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52, 61
short term, OR=.06; 95% CI, .02 to .22) and for
short term, SMD=.27; 95% CI, .02 to .53). In the mid- and long term a significant
40
23, 24, 62, 63
14
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38, 41, 42
reported on two-portal-endoscopic versus open or
M AN U
38, 40, 42, 44, 52-54, 61
41-43, 47-49, 67, 68
10, 40, 44-46, 50, 51, 53-55, 59-61, 66
SC
39
For the outcomes see above. In total 4 recent high-quality
22, 64, 65, 69
, two-portal: two high-quality RCTs
compared one or two-portal carpal tunnel release with
62, 63
23, 24
and two low-quality
22, 69
and two low-quality RCTs).
325
11
ACCEPTED MANUSCRIPT 326
Miniopen Technique Assisted by Knifelight Instrument Versus Standard (mini) Open Carpal
327
Tunnel Release
328
Systematic review. Two high-quality studies
329
review of Scholten et al , compared the miniopen technique assisted by the Knifelight instrument
330
versus standard open release or open release with mini-incision (≤3-months: OR=.76; 95% CI, .14-
331
4.28). Of these, only 1 low-quality study found a significant result in favor of the Knifelight instrument
332
on the symptom severity score after a mean follow-up of 19-months (range, 12-28months). However,
333
these results were not maintained at a mean follow-up of 30- (range, 24-42) or 60 -months.
334
Recent RCTs: Two low-quality studies
335
the Knifelight instrument versus standard open release. Elsharif et al (n=82) was a long term follow-
336
up of the study of Helm et al
337
al . A significant difference was found in favor of the Knifelight in the Quick-DASH (P=.0024) at 10-
338
years follow-up.
339
The low-quality study of Heidarian et al (n=59) did not find significant differences between groups on
340
pain at 3-weeks follow-up.
341
There is limited evidence that the miniopen technique assisted by the Knifelight instrument is more
342
effective than a standard open release in the long term, however, there is no evidence in the short and
343
midterm.
70, 71
72
and 1 low-quality study , included in the Cochrane
16
RI PT
72
73
74, 75
investigated the effect of the open technique assisted by
which was previously included in the Cochrane review of Scholten et
16
TE D
75
M AN U
71
SC
74
344
Modified Open Versus Standard Open Carpal Tunnel Release
346
Systematic review. Four high-quality
347
of Scholten et al reported on open tunnel release with a modified versus standard incision (4 RCTs
348
76, 78, 79, 81
349
and recovery between groups were found on short, mid- and, long term.
350
Recent RCTs. Three low-quality recent RCTs
351
al (n=120) compared minimal access carpal tunnel release with standard open carpal tunnel release
352
and found significant differences on the symptom severity scale and the functional status scale in
353
favor of the minimal access group at 6-months and 12-months follow-up (P<.001).
354
One RCT (n=90) reported significant difference on grip strength in favor of open carpal tunnel release
355
versus open carpal tunnel release short incision at 12-weeks follow-up (no P value given), but not at
EP
345
76-79
82
AC C
16
short term, 2 RCTs
68, 77
and 2 low-quality RCTs
68, 80
included in the Cochrane review
midterm and long term). No significant differences on pain, function,
22, 69, 82
were found. The low-quality study of Tarallo et
12
ACCEPTED MANUSCRIPT 356
24-weeks. No significant differences between groups were found on pain, pareasthesis and range of
357
motion.
358
Aslani et al , (n=96, low-quality) studied endoscopic carpal tunnel release (group 1) with regular open
359
carpal tunnel release (group 2) and mid-palmar mini incision (group 3). Significant differences between
360
groups were found on pain at 4 weeks (P<.05), for grip strength (P<.05) and weakness (P<.05) at 4-
361
months follow-up, all in favor of group 3 versus group 2. No significant differences were found on night
362
pain, numbness, stiffness, wrist pain and pain at 4-months follow-up.
363
There is conflicting evidence for the effectiveness of modified carpal tunnel release, compared with
364
standard open tunnel release in the short, mid- and, long term.
SC
365
RI PT
22
366
Carpal Tunnel Decompression With Preserving Technique Versus Standard Technique
367
Recent RCTs. The high-quality RCT
368
decompression by using a technique in order to preserve the superficial nerve branches compared
369
with a standard technique on scar pain scores or the second part of the Patient Evaluation Measure
370
score at 3- and 6-months follow-up.
371
Forward et al
372
parietal layer of the ulnar bursa to division of the ulnar bursa. No significant differences were found on
373
grip strength and the Patient Evaluation Measure score at 9-weeks follow-up.
374
No evidence was found in favor of nerve-preserving decompression versus standard decompression
375
of the carpal tunnel in the short and midterm. Furthermore, we found no evidence for open carpal
376
tunnel release with preservation of the parietal layer of the ulnar bursa compared to division of the
377
ulnar bursa in the short term.
M AN U
(n=84) found no significant differences in favor of carpal tunnel
EP
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(n=111, low-quality) compared open carpal tunnel release with preservation of the
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378
84
83
379
Steroids as Additive to Open Carpal Tunnel Release
380
Recent RCTs. Stepic et al
381
betamethasone as additive to open carpal tunnel release on symptom reduction at 7- and 90-days
382
follow-up, but no comparisons between groups were made.
383
Additional RCTs. Padua et al
384
nerve before skin closure as additive to release of the transverse carpal ligament. Significant
385
differences were found on the symptom severity score in favor of those treated with corticosteroid
85
(n=40, low-quality) examined a perineural injection of 1mL
86
(n=20, high-quality) studied corticosteroid irrigation of the median
13
ACCEPTED MANUSCRIPT irrigation versus the release-only group (P=.005) and no significant differences on the function severity
387
score in the short term.
388
There is no evidence for the effectiveness of a perineural steroid injection with 1mL betamethasone as
389
additive to open carpal tunnel release. Furthermore, there is moderate evidence that corticosteroid
390
irrigation of the median nerve before skin closure as additive to surgical release of the carpal ligament
391
is effective in the short term.
RI PT
386
392 393
Other Surgical Techniques
394
Systematic review. The Cochrane review of Scholten et al compared surgery with or without
395
regarding lengthening of the flexor retinaculum (1 high-quality study on short and midterm results),
396
surgery with or without internal neurolysis (1 high-quality study reporting on short term and 1 high-
397
quality study reporting on long term results; overall improvement ≤ 3-months, RR=1.02; 95% CI, .68-
398
1.54, and >3-months, RR=.92; 95% CI, .74-1.14). Moreover, surgery with or without epineurotomy
399
(overall improvement after 3-months, RR=.93, 95% CI, .58-1.50; 1 high-quality study , long term) and
400
surgery with or without tenosynovectomy (1 low-quality study,
401
in favor of one of the interventions studied was found.
402
Recent RCTs. In total three high-quality RCTs
403
One high-quality RCT of Crnkovic et al
404
longitudinal epineurotomy versus standard open carpal tunnel release. In contradiction to the study of
405
Leinberry et al , a significant difference on pain (10-point scale) was found in favor of the standard
406
carpal tunnel release at 180-days follow-up (MD=1.38; 95% CI, .26 to 2.49, P=.017).
407
Suppaphol et al
408
vision plus tunneling technique with standard open carpal tunnel release. Only in grip strength a
409
significant difference in favor of the limited open carpal tunnel release was found at 3-months follow-
410
up (P=.004).
411
Cho et al (n=84, high-quality) studied short wrist transverse open technique versus carpal tunnel
412
release with limited open technique. No significant differences were found on symptoms, function or
413
scar discomfort after 1- and 2-years.
16
SC
87
88
M AN U
89
65, 95-101
TE D
and eight low-quality RCTs
were found.
(n=50) studied open carpal tunnel release followed by
(n=30, high-quality) compared the limited open carpal tunnel release using direct
AC C
92
long term). No significant differences
EP
94
90
92-94
91
90
93
14
ACCEPTED MANUSCRIPT 96
414
Acar et al (n=159, low-quality) compared transverse carpal ligament releasing with and without distal
415
forearm fascia releasing. No significant differences between groups were found on pain or night-time
416
paraesthesia at 24-months follow-up.
417
In total three low-quality RCTs of Hamed et al (n=40), Castillo et al (n=30) and Vanni et al
418
(n=220) compared two incision - with standard open carpal tunnel release.
419
Hamed et al
420
6-months follow-up (P=0.04, P=0.03). No benefit was found on grip strength at 3- and 6-months
421
follow-up.
422
Castillo et al
423
score at 6 weeks (P=.03) and third finger score at 6-months (P=.04), both in favor of the standard
424
open carpal tunnel release. No significant differences were found on the functional status scale, the
425
Disabilities of the Arm, Shoulder and Hand Questionnaire, scar tenderness, radial pillar pain, ulnar
426
pillar pain, grip strength, pinch strength and the Semmes-Weinstein Monofilament score thumb at 3-
427
and 6-months.
428
Vanni et al compared the double tunnels technique to the standard open technique and found a
429
significant difference in favor of the double tunnels technique on pain (P<.05) and the Boston
430
Questionnaire (P<.05) at 12-months, but not at 3- or 6-months follow-up.
431
Cresswell et al (n=200, low-quality) studied carpal tunnel decompression using the Biomet TM
432
Indiana Tome (miniopen technique) versus standard limited palmar open incision and found significant
433
effects on the Levine-Katz questionnaire on symptoms at 7-years follow-up (P<.05). No significant
434
differences were found on the Levine-Katz questionnaire on symptoms 3-months after surgery; the
435
Levine-Katz questionnaire on function 3-months and 7-years after surgery; and pain, grip strength,
436
and pinch grip 3-months after surgery.
437
Zhang et al (n=213, low-quality) compared subneural reconstruction of the transverse carpal
438
ligament (group 1) with open carpal tunnel release (group 2) and endoscopic carpal tunnel release
439
(group 3). On the functional status scale (at 3-,6,12 and 24-months), cylindrical grip strength (3-,6-, 12-
440
and 24-months), pinch grip strength (at 6-,12- and 24-months) and the Michigan Hand Outcome (at
441
12- and 24-months) significant differences were found at 3-,6-,12-, and 24-months follow-up between
442
group 1 and 2 and between group 1 and 3, both in favor of group 1 (P<.032). No significant differences
98
99
found significant differences on pain in favor of the double incision technique at 3- and
found significant differences on the Semmes-Weinstein Monofilament, second finger
M AN U
SC
95
RI PT
98
95
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EP
97
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99
65
15
ACCEPTED MANUSCRIPT 443
between group 1 and 2 were found on the symptom severity scale, cylindrical grip strength and lateral
444
grip strength at 3-,6-,12- and 24-months follow-up.
445
Uçar et al
446
to flexor crease. No significant differences were found on the Boston Carpal Tunnel Questionnaire at
447
1-month follow-up.
448
Xu et al
449
versus standard open approach surgery. Significant differences were found in favor of coronal Z-type
450
lengthening of the transverse carpal ligament in grip strength at 6-months (P=.01) and 12-months
451
(P=.01), but not at 3-months follow-up.
452
In conclusion, there is no evidence with regard to open carpal tunnel release with versus without
453
lengthening of the flexor retinaculum in the short and midterm, internal neurolysis in the short term,
454
tenosynovectomy in the long term. There is moderate evidence for the effectiveness of direct vision
455
plus tunnelling technique compared with open carpal tunnel release in the short term. There is no
456
evidence in regard to short wrist transverse open technique versus carpal tunnel release with limited
457
open technique in the long term, transverse carpal ligament releasing with distal forearm fascia
458
releasing compared to without in the long term, carpal tunnel release with the incision distal compared
459
with proximal to the flexor crease in the long term, or miniopen technique using the Biomet TM Indiana
460
Tome compared with standard open incision in the short term.
461
There is limited evidence for the miniopen technique using the Biomet TM Indiana Tome compared
462
with standard open incision at 7-years of follow-up and for the subneural reconstruction of the
463
transverse carpal ligament compared with endoscopic carpal tunnel release in the short, mid- and,
464
long term. There is also limited evidence in favor of coronal Z-type lengthening of the transverse
465
carpal ligament compared with standard open approach surgery in the midterm and long term, but no
466
evidence in the short term. Further, there is conflicting evidence for the double compared with
467
standard single incision technique in the short and midterm and limited evidence in the long term.
468
Further, we found conflicting evidence for the effectiveness of epineurotomy on the median nerve
469
volume in the long term.
100
RI PT
(n=58, low-quality) compared coronal Z-type lengthening of the transverse carpal ligament
AC C
EP
TE D
M AN U
SC
101
(n=90, low-quality) compared carpal tunnel release with the incision distal versus proximal
470
16
ACCEPTED MANUSCRIPT 471
4. Postoperative Treatments
472
Systematic review. The Cochrane review of Peters et al
473
rehabilitation interventions following CTS surgery versus no treatment, placebo, or another
474
intervention; 13 high-quality RCTs
475
One high-quality study
476
strip (2-3 days) with long duration bulky dressing (9-14 days) after surgery. Significant differences in
477
favor of short duration bulky dressing were found on grip strength (MD=-16.0 (95% CI, -21.57 to -
478
10.43)) and tip pinch strength (MD=-1.20 (95% CI, -2.35 to -.05)) at 6- to 12-weeks follow-up. No
479
significant differences were found on the 3-point pinch - and lateral pinch strength at 6- to 12-weeks
480
follow-up. In one high-quality study
481
group after surgery to treat CTS. At 8-weeks follow-up, significant differences in favor of the retraining
482
program were found on the Shape-Texture Identification Test (MD=1.94 (95% CI, .68 to 3.20)) and the
483
Locognosia test (MD=6.31 (95% CI, 1.14 to 11.48)). No significant differences were found on the
484
Weinstein Enhanced Sensory Test, the 2-points discrimination and the Disabilities of the Arm,
485
Shoulder and Hand at 8-weeks follow-up. One high-quality study
486
plus exercises (group 1), laser therapy plus exercises (group 2) and exercises alone (group 3). For
487
pinch grip group 3 was more effective compared with group 1 and 2, in which group 2 was more
488
effective than group 1 at 6-weeks follow-up. For pain, group 1 was more effective compared with
489
group 2 and 3, in which group 2 was more effective compared with group 3 at 6-weeks follow-up. The
490
other studies
491
(versus placebo), splint versus bulky dressing, specialized home elevation device versus standard
492
sling, controlled cold therapy versus ice therapy, bulky dressing plus splint versus light dressing,
493
contrast bath plus exercise versus contrast bath versus exercises, Arnica versus placebo, high-dose
494
versus low-dose Arnica and multi-modal hand therapy versus normal activities/exercise, however no
495
significant differences between groups were found for outcomes on pain, function and recovery in the
496
short, mid- and/or long term.
497
Recent RCTs. Shalimar et al
498
limited open carpal tunnel release. No significant differences between groups were found on pain
499
(VAS), 2-point discrimination test radial and ulnar side of the index finger, pinch and grip strength,
17
and 9 low-quality RCTs
115-123
(total n=1521) were included.
compared short duration bulky dressing with replacement of an adhesive
, a sensory retraining program was compared with a control
M AN U
106
SC
RI PT
109
102-114
examined the effectiveness of
TE D
113
included in the review of Peters et al
17
compared: low-level laser
AC C
EP
102-105, 107, 108, 110-112, 114-123
compared continues ultrasound
124
, (n=30, high-quality) compared splint with soft bulky dressing after
17
ACCEPTED MANUSCRIPT power grade abductor pollicis brevis, the Boston Questionnaire Symptom Severity Scale, functional
501
status scale and scar and pillar pain at 6-months follow-up.
502
We found moderate evidence in favor of short duration dressing compared with long duration dressing
503
after carpal tunnel release and for the effectiveness of a postoperative sensory retraining program
504
compared with control in the short term. We found conflicting evidence for the effect of ultrasound plus
505
exercise versus laser therapy plus exercises and exercises alone after carpal tunnel release in the
506
short term. For the other post-operative interventions, no evidence was found in the short, mid- and,
507
long term.
RI PT
500
508
SC
509 DISCUSSION
511
This systematic review provides an overview of the effect of surgical and postsurgical interventions for
512
CTS. The RCTs concentrated on surgical versus non-surgical interventions, timing of surgery, various
513
surgical techniques and post-operative interventions. Strong and moderate evidence was found within
514
all these domains, except for timing of surgery. For the latter only one low quality study
515
with limited evidence that early surgery (<1 week after diagnosis) was more effective than delayed
516
surgery (>6 months after diagnosis).
517
Taking our results into consideration, surgical treatment seems to be more effective compared with
518
prolonged conservative treatment in the short, mid-, and, long term, although we found strong
519
evidence that a local corticosteroid injection is more effective than surgery in short term and moderate
520
evidence in favor of manual therapy compared with surgery in the short and midterm. This is in
521
agreement with the Cochrane review of Verdugo et al and the AAOS guideline. In the literature,
522
conservative treatment is preferred to treat mild to moderate cases of CTS and surgical treatment to
523
treat severe cases.
524
preoperative symptom severity.
525
RCTs exploring the optimal timing for surgery are scarce. We only found one RCT
526
early (<1 week after diagnosis) with delayed (>6 months after diagnosis) endoscopic carpal tunnel
527
release in patients with moderately severe CTS, in which limited evidence was found in favor of early
528
surgery in the midterm and long term. It might be possible that timing is an important factor for total
529
recovery after surgery. For example, a long-lasting compression can result in axonal damage, which
M AN U
510
was found
7
8
AC C
EP
TE D
37
6, 125
Future research should focus on stratifying treatment outcomes based on
37
that compared
18
ACCEPTED MANUSCRIPT 530
will not improve after surgery. More high-quality RCTs exploring the optimal timing of surgery are
531
required.
532
Although we found a large number of RCTs examining various surgical techniques of carpal tunnel
533
decompression, no unequivocal conclusion can be made which surgical treatment is superior to the
534
other in treating CTS. This is in agreement with the Cochrane review of Vasiliadis et al
535
reported no differences in the rates of major complications after endoscopic compared to open carpal
536
tunnel release. The Cochrane review of Scholten et al
537
standard open carpal tunnel release by existing alternative surgical procedure. Unless the theoretical
538
framework for the use of smaller or portal incision/preservation of superficial nerve branches/proximal
539
or distal incisions, it seems that the patients outcome is more based on the expertise procedure of the
540
surgeon compared to a specific technique.
541
Furthermore, we found one review (n=22 RCTs) concentrating on post-surgery treatments. Only two
542
RCTs found moderate evidence for effectiveness in the short term, a sensory retraining program
543
versus no program and short (2-3 days) versus a long (9-14 days) duration bulking dressing is of value
544
for better results in recovery after CTS surgery. More RCTs are needed to provide additional evidence
545
for this statement.
546
Other post-surgical interventions that are advised after CTS surgery by European experts are
547
instructions to the patient, splinting and exercise therapy. It would be interesting to continue studying
548
these post-surgical treatments in more detail in future research.
reported no evidence for replacing the
TE D
M AN U
SC
16
17
6
EP
549
which
RI PT
14
Study Limitations
551
Some methodological weaknesses of this review need to be addressed. First, we refrained from
552
statistic pooling of the data of the included studies, because of the heterogeneity of these studies. The
553
use of a best-evidence synthesis is a next-best solution and is considered to be a proven method that
554
is commonly used in the field of musculoskeletal disorders.
555
Second, 40% of the included RCTs had a methodological quality score of high-quality. More high-
556
quality RCTs are needed in order to support evidence-based practice.
557
Third, we included RCTs if an intervention for treating the disorder was evaluated and results on pain,
558
function, or recovery were reported, irrespectively of outcome measurement. Different scales are used
559
for outcome evaluation.
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550
20
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ACCEPTED MANUSCRIPT 560 561 CONCLUSIONS
563
Surgical treatment seems to be more effective than splinting or anti-inflammatory drugs plus hand
564
therapy in the short, mid- and/or long term to treat CTS. Although there is strong evidence that a local
565
corticosteroid injection is more effective than surgery in shortterm and moderate evidence that manual
566
therapy is more effective versus surgery in the short and midterm. We found no unequivocal evidence
567
that suggests one surgical treatment is more effective than the other, although we found moderate
568
evidence in favor of the direct vision plus tunnelling technique and corticosteroid irrigation of the
569
median nerve before skin closure as additive to carpal tunnel release compared with open carpal
570
tunnel release in the short term. For postsurgical treatments no unequivocal evidence for efficacy was
571
found, although we found moderate evidence that for the short term a short-duration dressing is
572
preferable over a long duration dressing and a sensory retraining program seems is more effective
573
than no program after CTS surgery. More research is definitely needed to study the optimal timing of
574
surgery in CTS.
M AN U
SC
RI PT
562
AC C
EP
TE D
575
20
ACCEPTED MANUSCRIPT 576
REFERENCES
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1. de Krom MC, Knipschild PG, Kester AD, Thijs CT, Boekkooi PF, Spaans F. Carpal tunnel syndrome: prevalence in the general population. J Clin Epidemiol 1992;45(4):373-6. 2. Huisstede BM, Miedema HS, Verhagen AP, Koes BW, Verhaar JA. Multidisciplinary consensus on the terminology and classification of complaints of the arm, neck and/or shoulder. Occup Environ Med 2007;64(5):313-9. 3. van Rijn RM, Huisstede BM, Koes BW, Burdorf A. Associations between workrelated factors and the carpal tunnel syndrome--a systematic review. Scand J Work Environ Health 2009;35(1):19-36. 4. de Krom MC, van Croonenborg JJ, Blaauw G, Scholten RJ, Spaans F. [Guideline 'Diagnosis and treatment of carpal tunnel syndrome']. Ned Tijdschr Geneeskd 2008;152(2):76-81. 5. Huisstede BMA, Hoogvliet P, Randsdorp MS, Glerum S, Van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part I: Effectiveness of conservative treatments - a systematic review. Arch Phys Med and Rehabil 2010;91:981–1004. 6. Huisstede BM, Friden J, Coert JH, Hoogvliet P, European HG. Carpal tunnel syndrome: hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline-results from the European HANDGUIDE Study. Arch Phys Med Rehabil 2014;95(12):2253-63. 7. Verdugo RJ, Salinas RA, Castillo JL, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev 2008(4):CD001552. 8. Graham B, Peljovich AE, Afra R, Cho MS, Gray R, Stephenson J et al. The American Academy of Orthopaedic Surgeons Evidence-Based Clinical Practice Guideline on: Management of Carpal Tunnel Syndrome. J Bone Joint Surg Am 2016;98(20):1750-4. 9. Aroori S, Spence RA. Carpal tunnel syndrome. Ulster Med J 2008;77(1):6-17. 10. Agee JM, McCarroll HR, Jr., Tortosa RD, Berry DA, Szabo RM, Peimer CA. Endoscopic release of the carpal tunnel: a randomized prospective multicenter study. J Hand Surg Am 1992;17(6):987-95. 11. Agee JM, McCarroll HR, North ER. Endoscopic carpal tunnel release using the single proximal incision technique. Hand Clin 1994;10(4):647-59. 12. Chow JC. Endoscopic release of the carpal ligament: a new technique for carpal tunnel syndrome. Arthroscopy 1989;5(1):19-24. 13. Chow JC. The Chow technique of endoscopic release of the carpal ligament for carpal tunnel syndrome: four years of clinical results. Arthroscopy 1993;9(3):301-14. 14. Vasiliadis HS, Georgoulas P, Shrier I, Salanti G, Scholten RJ. Endoscopic release for carpal tunnel syndrome. Cochrane Database Syst Rev 2014(1):CD008265. 15. Bland JD. Carpal tunnel syndrome. Bmj 2007;335(7615):343-6. 16. Scholten RJ, Mink van der Molen A, Uitdehaag BM, Bouter LM, de Vet HC. Surgical treatment options for carpal tunnel syndrome. Cochrane Database Syst Rev 2007(4):CD003905. 17. Peters S, Page MJ, Coppieters MW, Ross M, Johnston V. Rehabilitation following carpal tunnel release. Cochrane Database Syst Rev 2016;2:CD004158. 18. Huisstede BMA, Randsdorp MS, Coert J, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part II: Effectiveness of surgical treatments - a systematic review. Arch Phys Med Rehabil 2010;91(7):1005–1024. 19. Furlan AD, Pennick V, Bombardier C, van Tulder M. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976) 2009;34(18):1929-41.
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55. Westphal K, Bayat M, Wustner-Hofmann M, Hofmann A. Course of clinical symptoms before and after surgical decompression in carpal tunnel surgery. Lymphologie in Forschung Und Praxis 2000;4(2):69-73 56. Giele H. Bilateral simultaneous carpal tunnel release to prospectively compare endoscopic and open techniques. Journal of Hand Surgery;British Volume 2000(25B Suppl 1):28-9, Abstract no: 36. 57. Incoll IW, Bateman E, Myers A. Endoscopic vs open carpal tunnel release. Journal of Bone & Joint Surgery 2004;86B(Suppl IV):478–d. 58. Koskella KR, Alexander C. A comparison between open and endoscopic carpal tunnel release. Orthopaedic Transactions 1996;20(4):1102. 59. Sørensen AI, Boeckstyns ME, Nielsen NS, Haugegard M. Carpal tunnel release, a comparison of 3 methods - a preliminary report. Acta Orthopaedica Scandinavica 1997;68(Suppl 277):24–5. 60. Werber KD, Braver RB, Richtarsky I. Endoscopic carpal tunnel release versus open procedure: a prospective randomized study. Journal of Hand Surgery 1996;21 B(Suppl 1):11– 2. 61. Malhotra R, Kiran EK, Dua A, Mallinath SG, Bhan S. Endoscopic versus open carpal tunnel release: A short-term comparative study. Indian J Orthop 2007;41(1):57-61. 62. Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA 2015;314(13):1399-401. 63. Gumustas SA, Ekmekci B, Tosun HB, Orak MM, Bekler HI. Similar effectiveness of the open versus endoscopic technique for carpal tunnel syndrome: a prospective randomized trial. Eur J Orthop Surg Traumatol 2015;25(8):1253-60. 64. Michelotti B, Romanowsky D, Hauck RM. Prospective, randomized evaluation of endoscopic versus open carpal tunnel release in bilateral carpal tunnel syndrome: an interim analysis. Ann Plast Surg 2014;73 Suppl 2:S157-60. 65. Zhang X, Li Y, Wen S, Zhu H, Shao X, Yu Y. Carpal tunnel release with subneural reconstruction of the transverse carpal ligament compared with isolated open and endoscopic release. Bone Joint J 2015;97-B(2):221-8. 66. Mackenzie DJ, Hainer R, Wheatley MJ. Early recovery after endoscopic vs. shortincision open carpal tunnel release. Ann Plast Surg 2000;44(6):601-4. 67. Wong KC, Hung LK, Ho PC, Wong JM. Carpal tunnel release. A prospective, randomised study of endoscopic versus limited-open methods. J Bone Joint Surg Br 2003;85(6):863-8. 68. Eichhorn J, Dieterich K. Open versus endoscopic carpal tunnel release. Results of a prospective study. Chirurgische Praxis 2003;61(2):279-83. 69. Larsen MB, Sorensen AI, Crone KL, Weis T, Boeckstyns ME. Carpal tunnel release: a randomized comparison of three surgical methods. J Hand Surg Eur Vol 2013;38(6):646-50. 70. Bhattacharya R, Birdsall PD, Finn P, Stothard J. A randomized controlled trial of knifelight and open carpal tunnel release. J Hand Surg Br 2004;29(2):113-5. 71. Helm RH, Vaziri S. Evaluation of carpal tunnel release using the Knifelight instrument. J Hand Surg Br 2003;28(3):251-4. 72. Cellocco P, Rossi C, Bizzarri F, Patrizio L, Costanzo G. Mini-open blind procedure versus limited open technique for carpal tunnel release: a 30-month follow-up study. J Hand Surg Am 2005;30(3):493-9. 73. Cellocco P, Rossi C, El Boustany S, Di Tanna GL, Costanzo G. Minimally invasive carpal tunnel release. Orthop Clin North Am 2009;40(4):441-8, vii.
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74. Elsharif M, Papanna M, Helm R. Long-term follow up outcome results of Knifelight carpal tunnel release and conventional open release following a departmental randomized controlled trial. A prospective study. Pol Orthop Traumatol 2014;79:67-70. 75. Heidarian A, Abbasi H, Hasanzadeh Hoseinabadi M, Hajialibeyg A, Kalantar Motamedi SM, Seifirad S. Comparison of Knifelight Surgery versus Conventional Open Surgery in the Treatment of Carpal Tunnel Syndrome. Iran Red Crescent Med J 2013;15(5):385-8. 76. Brüser P, Richter M, Larkin G, Lefering R. The operative treatment of carpal tunnel syndrome and its relevance to endoscopic release. European Journal of Plastic Surgery 1999;22(2-3):80-4. 77. Citron ND, Bendall SP. Local symptoms after open carpal tunnel release. A randomized prospective trial of two incisions. J Hand Surg Br 1997;22(3):317-21. 78. Jugovac I, Burgic N, Micovic V, Radolovic-Prenc L, Uravic M, Golubovic V et al. Carpal tunnel release by limited palmar incision vs traditional open technique: randomized controlled trial. Croat Med J 2002;43(1):33-6. 79. Nakamichi K, Tachibana S. Ultrasonographically assisted carpal tunnel release. J Hand Surg Am 1997;22(5):853-62. 80. Nitzsche T, Steen M. Open and modified open surgery technique to split the retinaculum flexorum in treatment of carpal tunnel syndrome. Deutsche Gesellschaft Fur Chirurgie 1999;Suppl Kongressband II:999-1001. 81. Richter VM, Bruser P. [Surgical treatment of carpal tunnel syndrome: a comparison between long and short incision and endoscopic release]. Handchir Mikrochir Plast Chir 1996;28(3):160-6. 82. Tarallo M, Fino P, Sorvillo V, Parisi P, Scuderi N. Comparative analysis between minimal access versus traditional accesses in carpal tunnel syndrome: a perspective randomised study. J Plast Reconstr Aesthet Surg 2014;67(2):237-43. 83. Siegmeth AW, Hopkinson-Woolley JA. Standard open decompression in carpal tunnel syndrome compared with a modified open technique preserving the superficial skin nerves: a prospective randomized study. J Hand Surg [Am] 2006;31(9):1483-9. 84. Forward DP, Singh AK, Lawrence TM, Sithole JS, Davis TR, Oni JA. Preservation of the ulnar bursa within the carpal tunnel: does it improve the outcome of carpal tunnel surgery? A randomized, controlled trial. J Bone Joint Surg Am 2006;88(11):2432-8. 85. Stepic N, Novakovic M, Martic V, Peric D. Effects of perineural steroid injections on median nerve conduction during the carpal tunnel release. Vojnosanit Pregl 2008;65(11):8259. 86. Padua R, Padua L, Bondi R, Campi A, Ceccarelli E, Padua S. Intrasurgical use of steroids on carpal tunnel syndrome: A randomized, prospective, double-blind controlled study. Journal of Orthopaedics and Traumatology. 2003. p 76-80. 87. Dias JJ, Bhowal B, Wildin CJ, Thompson JR. Carpal tunnel decompression. Is lengthening of the flexor retinaculum better than simple division? J Hand Surg Br 2004;29(3):271-6. 88. Lowry WE, Jr., Follender AB. Interfascicular neurolysis in the severe carpal tunnel syndrome. A prospective, randomized, double-blind, controlled study. Clin Orthop Relat Res 1988;227:251-4. 89. Mackinnon SE, McCabe S, Murray JF, Szalai JP, Kelly L, Novak C et al. Internal neurolysis fails to improve the results of primary carpal tunnel decompression. J Hand Surg Am 1991;16(2):211-8. 90. Leinberry CF, Hammond NL, 3rd, Siegfried JW. The role of epineurotomy in the operative treatment of carpal tunnel syndrome. J Bone Joint Surg Am 1997;79(4):555-7.
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91. Shum C, Parisien M, Strauch RJ, Rosenwasser MP. The role of flexor tenosynovectomy in the operative treatment of carpal tunnel syndrome. J Bone Joint Surg Am 2002;84-A(2):221-5. 92. Suppaphol S, Worathanarat P, Kawinwongkovit V, Pittayawutwinit P. The comparison between limited open carpal tunnel release using direct vision and tunneling technique and standard open carpal tunnel release: a randomized controlled trial study. J Med Assoc Thai 2012;95(4):532-6. 93. Cho YJ, Lee JH, Shin DJ, Park KH. Comparison of short wrist transverse open and limited open techniques for carpal tunnel release: a randomized controlled trial of two incisions. J Hand Surg Eur Vol 2016;41(2):143-7. 94. Crnkovic T, Bilic R, Trkulja V, Cesarik M, Gotovac N, Kolundzic R. The effect of epineurotomy on the median nerve volume after the carpal tunnel release: a prospective randomised double-blind controlled trial. Int Orthop 2012;36(9):1885-92. 95. Castillo TN, Yao J. Prospective randomized comparison of single-incision and twoincision carpal tunnel release outcomes. Hand (N Y) 2014;9(1):36-42. 96. Acar MA, Kutahya H, Gulec A, Elmadag M, Karalezli N, Ogun TC. Triggering of the Digits After Carpal Tunnel Surgery. Ann Plast Surg 2015;75(4):393-7. 97. Cresswell TR, Heras-Palou C, Bradley MJ, Chamberlain ST, Hartley RH, Dias JJ et al. Long-term outcome after carpal tunnel decompression - a prospective randomised study of the Indiana Tome and a standard limited palmar incision. J Hand Surg Eur Vol 2008;33(3):332-6. 98. Hamed AR, Makki D, Chari R, Packer G. Double- versus single-incision technique for open carpal tunnel release. Orthopedics 2009;32(10). 99. Vanni D, Sirabella FS, Galzio R, Salini V, Magliani V. The double tunnels technique: an alternative minimally invasive approach for carpal tunnel syndrome. J Neurosurg 2015;123(5):1230-7. 100. Ucar BY, Demirtas A, Bulut M, Azboy I, Ucar D. Carpal tunnel decompression: two different mini-incision techniques. Eur Rev Med Pharmacol Sci 2012;16(4):533-8. 101. Xu L, Huang F, Hou C. Treatment for carpal tunnel syndrome by coronal Z-type lengthening of the transverse carpal ligament. J Pak Med Assoc 2011;61(11):1068-71. 102. Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol 2010;223(1):192-202. 103. Hochberg J. A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release. J Hand Ther 2001;14(3):208-15. 104. Janssen RG, Schwartz DA, Velleman PF. A randomized controlled study of contrast baths on patients with carpal tunnel syndrome. J Hand Ther 2009;22(3):200-7; quiz 8. 105. Jeffrey SL, Belcher HJ. Use of Arnica to relieve pain after carpal-tunnel release surgery. Altern Ther Health Med 2002;8(2):66-8. 106. Jerosch-Herold C, Shepstone L, Miller L. Sensory relearning after surgical treatment for carpal tunnel syndrome: a pilot clinical trial. Muscle Nerve 2012;46(6):885-90. 107. Martins RS, Siqueira MG, Simplicio H. Wrist immobilization after carpal tunnel release: a prospective study. Arq Neuropsiquiatr 2006;64(3A):596-9. 108. Pomerance J, Fine I. Outcomes of carpal tunnel surgery with and without supervised postoperative therapy. J Hand Surg [Am] 2007;32(8):1159-63; discussion 64-5. 109. Ritting AW, Leger R, O'Malley MP, Mogielnicki H, Tucker R, Rodner CM. Duration of postoperative dressing after mini-open carpal tunnel release: a prospective, randomized trial. J Hand Surg Am 2012;37(1):3-8. 110. Stevinson C, Devaraj VS, Fountain-Barber A, Hawkins S, Ernst E. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery. J R Soc Med 2003;96(2):60-5.
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111. Williams AM, Baker PA, Platt AJ. The impact of dressings on recovery from carpal tunnel decompression. J Plast Reconstr Aesthet Surg 2008;61(12):1493-5. 112. Powell F. Desensitisation techniques: do they reduce scar sensitivity following carpal tunnel release? (A pilot study). Unpublished Masters Thesis 2003. 113. Sawan SA, Sayed Mahmoud HM, Hussien MM. Effect of different physical therapy modalities on post-operative recovery following transverse carpal ligament release: a randomized controlled trial. Physiotherapy Practice and Research 2013;34(2):75–82. 114. Alves MPT, Araujo GCS. Low-level laser therapy after carpal tunnel release. Revista Brasileira de Ortopedia 2011;46(6):697–701. 115. Bhatia R, Field J, Grote J, Huma H. Does splintage help pain after carpal tunnel release? J Hand Surg Br 2000;25(2):150. 116. Bury TF, Akelman E, Weiss AP. Prospective, randomized trial of splinting after carpal tunnel release. Ann Plast Surg 1995;35(1):19-22. 117. Cebesoy O, Kose KC, Kuru I, Altinel L, Gul R, Demirtas M. Use of a splint following open carpal tunnel release: a comparative study. Adv Ther 2007;24(3):478-84. 118. Cook AC, Szabo RM, Birkholz SW, King EF. Early mobilization following carpal tunnel release. A prospective randomized study. J Hand Surg [Br] 1995;20(2):228-30. 119. Fagan DJ, Evans A, Ghandour A, Prabhkaran P, Clay NR. A controlled clinical trial of postoperative hand elevation at home following day-case surgery. J Hand Surg Br 2004;29(5):458-60. 120. Finsen V, Andersen K, Russwurm H. No advantage from splinting the wrist after open carpal tunnel release. A randomized study of 82 wrists. Acta Orthop Scand 1999;70(3):28892. 121. Huemer GM, Koller M, Pachinger T, Dunst KM, Schwarz B, Hintringer T. Postoperative splinting after open carpal tunnel release does not improve functional and neurological outcome. Muscle Nerve 2007;36(4):528-31. 122. Provinciali L, Giattini A, Splendiani G, Logullo F. Usefulness of hand rehabilitation after carpal tunnel surgery. Muscle Nerve 2000;23(2):211-6. 123. Li GF, Tian DH, Yu JL, Li WZ, Meng J. Synergistic effects of compound physical factor treatment on neurological outcome after peripheral nerve entrapment surgery - A randomized controlled study. Neural Regeneration Research 2008;3(1):97-100. 124. Shalimar A, Nor-Hazla MH, Arifaizad A, Jamari S. Splinting after Carpal Tunnel Release: Does it really Matter? Malaysian Orthopaedic Journal 2015;9(2). 125. Duncan KH, Lewis RC, Jr., Foreman KA, Nordyke MD. Treatment of carpal tunnel syndrome by members of the American Society for Surgery of the Hand: results of a questionnaire. J Hand Surg Am 1987;12(3):384-91.
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Figure 1: Flow chart of the literature search
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ACCEPTED MANUSCRIPT Table 1: Best-evidence synthesis - levels of scientific evidence.20
The level of evidence was ranked and divided in the following levels:
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Strong evidence for effectiveness: consistent (i.e. ≥75% of the trials report the same findings) positive (significant) findings within multiple higher quality RCTs. Moderate evidence for effectiveness: consistent positive (significant) findings within multiple lower quality RCTs and/or 1 high-quality RCT. Limited evidence for effectiveness: consistent positive (significant) findings within 1 low-quality RCT. Conflicting evidence for effectiveness: provided by conflicting (significant) findings in the RCTs (<75% of the studies report consistent findings). No evidence found for effectiveness of the inventions: RCTs available, but no (significant) differences between intervention and control groups were reported. No systematic review or RCT found.
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ACCEPTED MANUSCRIPT
Blinding? Caregiver?
Blinding? Outcome assessors?
Incomplete outcome data addressed? Dropouts?
Incomplete outcome data? ITT analysis?
Free of suggestions of selective outcome reporting?
Similarity of baseline characteristics?
Co-interventions avoided or similar?
Compliance acceptable in all groups?
Timing of the outcome assessment similar?
Maximum score
Study score
+ + + +
+ + -
-
+ + + +
+ + + +
+ + + +
+ + + +
? + ?
+ ? ? +
NA NA NA ?
+ + + +
11 11 11 12
9 8 8 8
82 73 73 67
+ + + ? + + + + + +
+ + + ? ? ? ? ? + ?
+
-
+ + ? ? ? + ? + ? ?
+ + + + + + + +
+ ? + + + + + + +
+ + + ? + + + + + +
+ ? + + + + + ? + ?
+ ? + + ? ? ? ?
NA NA ? NA NA NA NA NA NA
+ ? + + + + + + + +
12 11 11 12 11 11 11 11 11 11
8 7 7 7 6 6 6 6 6 6
67 64 64 58 55 55 55 55 55 55
+ + + ? + + + ? + ? ? ? ? ? ? ? ?
? ? + ? ? ? ? + ? ? ? ? ? ? ? ? ? ?
+ ? ? ? ? -
? -
? ? ? ? + ? + ? ? ? ? ? ? ?
+ + + + + + + ? + ? ? ? ? ? ? + ?
+ + + + + ? ? ? ? + ? ? ? ? ? ?
+ + + + + + + + + + + + + + + + +
+ ? ? + + + ? ? ? + ? ? ? ? ? + ? ?
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? -
NA NA NA NA ? NA NA NA NA NA NA NA NA NA NA NA NA NA NA
+ + + + + + + + + ? + + + + +
11 11 11 11 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11
5 5 5 5 5 4 4 4 4 3 3 3 2 2 2 2 2 2 2
45 45 45 45 42 36 36 36 36 27 27 27 18 18 18 18 18 18 18
SC
M AN U
TE D
AC C
+ = yes: - = no: ? = unsure: NA = not attempted
Percentage
Blinding? Patients?
+ + + +
RI PT
Allocation concealment?
94
Crnkovic et al 86 Padua et al 92 Suppaphol et al Fernandez-de-las32 Penas et al 33 Jarvik et al 62 Atroshi et al 93 Cho et al 124 Shalimar et al 23 Ejiri et al 63 Gumustas et al 36 Ismatullah et al 24 Kang et al 30 Ly-Pen et al Siegmeth and 83 Hopkinson-Woolley 37 Chandra et al 74 Elsharif et al 84 Forward et al 82 Tarallo et al 25 Ucan et al 96 Acar et al 95 Castillo and Yao 98 Hamed et al 69 Larsen et al 97 Cresswell et al 64 Michelotti et al 99 Vanni et al 35 Andreu et al 22 Aslani et al 75 Heidarian et al 85 Stepic et al 100 Ucar et al 101 Xu et al 65 Zhang et al
EP
Reference
Adequate randomization?
Table 2: Methodological quality scores of the included RCTs
ACCEPTED MANUSCRIPT 14
+ + +
+ + + + + ? ?
+ + + ? ? ?
+ + + ? + ?
7 7 7 7 7 7 7
5 5 3 3 2 2 2
71 71 43 43 29 29 29
? + ? ? ? ? ? ?
? ? ? ? ? ?
-
+ + + -
? ? ? + ? ? + + +
? ? ? ? ? -
+ + ? ? ? + ? ? ?
7 7 7 7 7 7 7 7 7
2 2 1 1 1 1 1 1 1
29 29 14 14 14 14 14 14 14
? ? ?
?
-
-
? -
? ? ?
? ?
7 7 7
0 0 0
0 0 0
? ? ? ?
? ? ? ?
-
-
? ? ? ?
? ? ? ?
? ? ?
7 7 7 7
0 0 0 0
0 0 0 0
? ? ? ? ?
? ? ? ?
-
-
? ? ? ?
? ? ? ? ?
? ? ? ? ?
7 7 7 7 7
0 0 0 0 0
0 0 0 0 0
Percentage
Study score
SC
M AN U
TE D
AC C 14
RI PT
Incomplete outcome data
-
Maximum score
Blinding outcome assessment
+ + ? ? ? ?
Other bias
Blinding participants and personnel
+ + ? + + +
Selective reporting
Allocation concealment?
38
Atroshi et al 39 Tüzüner et al 46 Hoefnagels et al 50 Saw et al 40 Sennwald et al 41 Brown et al Ferdinand and 44 MacLean 54 Trumble et al 67 Wong et al 57 Incoll et al 47 Jacobsen et al 48 Macdermid et al 61 Malhotra et al 49 Rab et al 51 Schäfer et al Stark and Engkvist52 Löfmark 10 Agee et al 42 Dumontier et al Eichhorn and 68 Dieterich 43 Erdmann 45 Foucher et al 56 Giele et al Koskella and 58 Alexander 66 Mackenzie et al 59 Sørensen et al 53 Tian et al 60 Werber et al 55 Westphal et al
EP
Reference
Random sequence generation
Table 3: Methodologic quality scores of the Cochrane Review of Vasiliadis et al
The review of Vasiliadis et al applied for the methodologic quality scores the methodological quality 27 criteria of the Cochrane Collaboration's Tool + = yes: - = no: ? = unsure
ACCEPTED MANUSCRIPT 16
Assessment timing similar?
Intention to treat analysis?
? + NA + NA NA ? NA
+ + + + ? ?
+ + + + ? + ? ?
+ + + + + + ? ?
+ + ? -
M AN U
TE D
16
9 9 8 9 8 8 9 8
Percentage
Drop-out rate described and acceptable?
+ + ? + + ? ? ?
Study score
Blinding outcome assessors?
+ + ? + + ? ?
RI PT
Blinding patient?
? ? + + ? ? ?
Maximum score
Co-interventions avoided or similar?
+ + + + + + + ?
SC
Similar at baseline?
90
Leinberry et al 89 Mackinnon et al 78 Jugovac et al 88 Lowry et al 70 Bhattacharya et al 71 Helm et al 91 Shum et al Eichhorn and 68 Dieterich
Allocation concealment?
Reference
Randomization?
Table 4: Methodologic quality scores of the Cochrane Review of Scholten et al
7 7 6 6 5 4 1 0
78 78 75 67 63 50 11 0
AC C
EP
The review of Scholten et al applied for the methodologic quality scores the methodological quality 20 criteria of van Tulder et al + = yes: - = no: ? = unsure: NA = not attempted
ACCEPTED MANUSCRIPT 7
7
RI PT
SC
Percentage
NA NA NA NA
Study score
+ + + NR
Maximum score
+ + + ?
M AN U
Patient blinded?
+ + + +
Observer blinded?
Baseline differences?
30
Ly-Pen et al 29 Gerritsen et al 31 Hui et al 28 Garland et al
Allocation concealment?
Reference
Randomization?
Table 5: Methodologic quality scores of the Cochrane Review of Verdugo et al
NA NA
3 4 4 3
3 3 3 1
100 75 75 33
The review of Verdugo et al applied for the methodologic quality scores the methodological quality 26 criteria of Schultz et al
AC C
EP
TE D
+ = yes: - = no: ? = unsure: NA = not attempted: NR = not reported
ACCEPTED MANUSCRIPT 17
Blinding self-reported outcomes
Blinding other outcomes
Incomplete outcome data 12 weeks or less
Incomplete outcome data after 12 weeks
Selective reporting
Other bias
Maximum score
Study score
Percentage
+ + ?
+ ? +
+ + +
+ + +
+ + +
NA NA NA
+ + +
+ + +
7 7 7
7 6 6
100 86 86
+
+
-
+
+
?
+
+
8
6
75
+
+
-
+
+
+
-
+
8
6
75
+ + + -
+ + -
+ +
+ + + -
+ + + +
? NA +
+ + + +
+ ? + +
8 8 7 8
6 6 5 5
75 75 71 63
+ + + + + ? + ? ? -
? ? ? ? ? ? ? ? ? ? -
-
+ + ? ? ? ? ? ? + ? ?
+ + + + + ? + NA + ? ? -
NA NA NA + NA NA ? NA NA ? -
+ + + + + + -
+ + + + + + + + + + + + +
7 7 7 8 7 7 8 8 7 7 7 8 8
4 4 4 4 3 3 3 3 2 2 2 1 1
57 57 57 50 43 43 38 38 29 29 29 13 13
SC
M AN U
TE D
AC C 17
RI PT
Allocation concealment?
112
Powell et al 104 Janssen et al Jeffrey and 105 Belcher Jerosch-Herold 106 et al Pomerance and 108 Fine 113 Sawan et al 110 Stevinson et al 111 Williams et al Alves and 114 Araujo 103 Hochberg et al 107 Martins et al 109 Ritting et al 102 Gordon et al 117 Cebesoy et al 119 Fagan et al 115 Bhatia et al 123 Li et al 116 Bury et al 121 Huemer et al 122 Provinciali et al 118 Cook et al 120 Finsen et al
EP
Reference
Random sequence generation
Table 6: Methodologic quality scores of the Cochrane Review of Peters et al
The review of Peters et al applied for the methodologic quality scores the methodological quality 27 criteria of the Cochrane Collaboration's Tool + = yes: - = no: ? = unsure: NA = not attempted
ACCEPTED MANUSCRIPT Table 7: Strong and Moderate Evidence for Effectiveness of Surgical Interventions for CTS Surgery to treat carpal tunnel syndrome Surgery vs non-surgical √a,b,c,d,e,f,g Timing of surgery 0 Various surgical techniques √ h,i Post-surgical √j,k
RI PT
√: strong or moderate evidence found; 0: RCT(s) found, but only limited, conflicting or no evidence for effectiveness of interventions was found. Short-term: Strong evidence: surgical treatment vs corticosteroid injections* f Moderate evidence: surgical treatment vs manual therapy* h Moderate evidence: corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release i Moderate evidence: direct vision plus tunneling technique* vs standard open carpal tunnel release j Moderate evidence: short dressing* vs long duration bulky dressing k Moderate evidence: postoperative sensory retraining program* vs no program Midterm: a Moderate evidence: surgical treatment* vs splinting d Moderate evidence: surgical treatment* vs anti-inflammatory drugs plus hand therapy g Moderate evidence: surgical treatment vs manual therapy* Long-term: b Moderate evidence: surgical treatment* vs splinting e Moderate evidence: surgical treatment* vs anti-inflammatory drugs plus hand therapy * in favor of
AC C
EP
TE D
M AN U
SC
c
ACCEPTED MANUSCRIPT
Table 8. Complete overview of evidence for effectiveness of surgical interventions for carpal tunnel syndrome
++ ++
++ ++ NE
RI PT
Post-operative ►Short* vs long duration bulky dressing Short-term: ►Postoperative sensory retraining program* vs non Short-term: ►Ultrasound plus exercise vs laser therapy plus exercise Short-term: ►Ultrasound plus exercise vs exercise alone Short-term: ►Laser therapy plus exercise vs exercise alone Short-term: ►Low level laser vs placebo Short-term: Midterm: ►Splint vs (soft) bulky dressing Short-term: Midterm: ►Specialized home elevation device vs standard sling Short-term: Midterm:
SC
± ± ±
± NE NE
M AN U
TE D
+++ NE +
EP
± ++ ++
SURGICAL TREATMENT Timing of surgery Various surgical techniques ►Early surgery* ►Endoscopic* vs standard <1wk after open carpal tunnel release diagnosis Short-term: vs delayed Midterm: surgery >6mo Long-term: after ►Endoscopic vs miniopen diagnosis carpal tunnel release Midterm: + Short-term: Long-term: + Midterm: Long-term: ►One-portal endoscopic vs open carpal tunnel release Short-term: Midterm: Long-term: ►Two-portal endoscopic vs open carpal tunnel release Short-term: Midterm: Long-term: ►Mini-open technique assisted by Knifelight Instrument* vs standard open release Short-term: Midterm: Long-term: ►Modified open* vs standard open release incision Short-term: Midterm: Long-term:
AC C
Surgical vs non-surgical ►Surgical treatment* vs splinting Short-term: Midterm: Long-term : ►Surgical treatment vs corticosteroid* injections Short-term: Midterm: Long-term : ►Surgical treatment* vs anti-inflammatory drugs plus handtherapy (plus ultrasound in cases not responding to handtherapy) Midterm : Long-term: ►Surgical treatment vs manual therapy* Short-term: Midterm: Long-term:
± ± NE
± ± ±
NE NE +
± ± ±
++
++
NE
NE
NE
NE NE
NE NE
NE NE
ACCEPTED MANUSCRIPT
RI PT
SC
NE NE
►Controlled cold therapy vs ice therapy Short-term: Midterm: ►Bulky dressing plus splint vs light dressing Short-term: ►Contrast bath plus exercise vs no exercise Short-term: Midterm: ►Arnica vs placebo ►High dosis arnica vs low dosis Short-term: Midterm: ►Multi-modal hand therapy vs normal activities/exercise Short-term: Midterm:
NE
AC C
EP
TE D
M AN U
►Nerve- preserving decompression vs standard decompression of the carpal tunnel Short-term: Midterm: ►Open carpal tunnel release with vs without preservation of the ulnar bursa Short-term: ►Open carpal tunnel release with perineural steroid injection immediately after decompression vs no perineural steroid injection after decompression Short-term: ►Corticosteroid irragiation* of the median nerve before skin closure as additive to carpal tunnel release: Short-term: ►With vs without lengthening of the flexor retinaculum in open carpal tunnel release Short-term: Midterm: ► With vs without internal neurolysis in open carpal tunnel release Short-term:
NC
++
NE NE
NE
NE NE
NE
NE NE
NE NE
NE NE
ACCEPTED MANUSCRIPT
SC
NE
RI PT
NE
++
AC C
EP
TE D
M AN U
►With vs without epineurotomy in open carpal tunnel release Long-term: ►With vs without tenosynovectomy in open carpal tunnel release Long-term: ►Direct vision plus tunneling technique* vs standard open carpal tunnel release Short-term: ►Short wrist transverse vs limited open technique Long-term: ►Transverse carpal ligament releasing with vs without distal forearm fascia releasing Long-term: ►Mini-open Technique using the Biomet TM Indiane Tome vs standard open limited incision Short-term: Long-term: ►Double tunnels technique* vs standard open technique Short-term: Midterm: Long-term: ►Subneural reconstruction of the transverse carpal ligament* vs endoscopic carpal tunnel release
NE
NE
NE NE
± ± +
ACCEPTED MANUSCRIPT
SC
+ + +
RI PT
+ + +
NE
M AN U
Short-term: Midterm: Long-term: ►Subneural reconstruction of the transverse carpal ligament* vs open carpal tunnel release Short-term: Midterm: Long-term: ►Incision distal vs proximal to flexor crease Short-term: ►Coronal Z-type lengthening of the transverse carpal ligament* vs standard open approach Short-term: Midterm: Long-term:
NE + +
AC C
EP
TE D
Abbreviations: vs, versus; wk, weeks; mo, months. X: No systematic review (SR) or randomized clinical trial (RCT) found. +: limited evidence found; ++: moderate evidence found; +++: strong evidence found; ±: conflicting evidence for effectiveness. NC: RCT was found, but no comparison was made between the intervention and control groups, thus no evidence was found. NE: no evidence found for effectiveness of the treatment: RCT(s) available, but no differences were found between intervention and control groups. *: in favor of. Different surgical techniques: Open carpal tunnel release: the carpal tunnel ligament is divided by a (5 cm) palmar incision. Modified open carpal tunnel release: the carpal tunnel ligament is divided by a (5 cm) palmar incision with preservation of superficial nerve branches crossing the incision site. Mini-open carpal tunnel release: the carpal tunnel ligament is divided by a smaller (1-2 cm) palmar incision. Miniopen technique assisted by Knifelight instrument: a special knife with a battery-operated trans illuminating light source introduced through a small, proximal or distal incision. Endoscopic carpal tunnel release: division of the transverse carpal ligament with the use of an endoscopic camera, optic fiber light source and monitor performed with one or two portals, whilst leaving overlying structures intact. Single portal endoscopic carpal tunnel release: one small incision (portal) proximal or distal to the carpal tunnel to indirect access to the bottom surface of the transverse ligament. Two portal endoscopic carpal tunnel release: two small incision (portal) proximal or distal to the carpal tunnel to indirect access to the bottom surface of the transverse ligament.
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
ACCEPTED MANUSCRIPT
Appendix 1: Systematic reviews: CTS No. of patients/ hands
Treatment
Control/ Comparison
Outcome Measures
Effect Size
Splinting
Clinical improvement
3mo: RR=1.38 (95% CI, 1.08 to 1.75)
RI PT
Author
Surgical versus nonsurgical Surgery
SC
349
Steroid injection
Clinical improvement
TE D
Surgery
2586
Endoscopic (twoor one-portal) carpal tunnel release
AC C
Vasiliadis et 14 al (28 RCTs)
EP
Grip strength
Various surgical techniques
(1 RCT) in favor of surgery 6mo: RR=1.29 (95% CI, 1.08 to 1.55) (1 RCT) in favor of surgery 1 year: RR=1.27 (95% CI, 1.05 to 1.53) (2 RCTs) in favor of surgery 3mo: RR=.66 (95% CI, .49 to .90) in favor of steroid injection 3mo: RR=2.18 (95% CI, 1.39 to 3.42) (2 RCTs) in favor of steroid injection 6mo: RR=.95 (95% CI, .71 to 1.29) (1 RCT) 1y: not significant (no RR given) 20wk: RR=.71 (95% CI, .43 to 1.15)
M AN U
Verdugo et 7 al (4 RCTs)
Open carpal tunnel release
Overall improvement Symptom severity scale (Levine)
Function status scale (Levine)
> 3mo: RR=1.05 (95% CI, .96 to 1.15) ≤ 3mo: WMD= -.09 (95% CI, -.48 to .30) > 3mo: WMD=.02 (95% CI, -.18 to .22) ≤ 3mo: WMD=-.19 (95% CI, -.61 to .23) > 3mo: WMD=.01 (95% CI, -.14 to
ACCEPTED MANUSCRIPT
RI PT
Pain
M AN U
Modified open carpal tunnel release
Overall improvement
Symptom severity scale (Levine) Function status scale (Levine) Pain
EP
TE D
Endoscopic (twoor one-portal) carpal tunnel release
SC
Numbness
Grip strength
AC C
Grip strength
Two-portal endoscopic carpal tunnel release
.16) ≤ 3mo: WMD=-.41 (95% CI, -.65 to -.18) in favor of endoscopic release RR=.49 (95% CI, .21 to 1.15) > 3mo: MD=-5.20 (95% CI, -12.65 to 2.25) RR=.88 (95% CI, .57 to 1.38) ≤ 3mo: RR=1.14 (95% CI, .76 to 1.71) > 3mo: MD=.06 (95% CI, -.04 to .16) RR=.64 (95% CI, .31 to 1.35) ≤ 3mo: WMD=.40 (95% CI, .10 to .71) in favor of endoscopic release > 3mo: WMD=1.13 (95% CI, .56 to 1.71) in favor of endoscopic release ≤ 3mo: RR=1.11 (95% CI, .89 to 1.38) > 3mo: RR=.89 (95% CI, .59 to 1.35) ≤ 3mo: MD= -.37 (95% CI, -1.01 to .27) ≤ 3mo: MD=-.48 (95% CI, -1.14 to .17) ≤ 3mo: WMD=.01 (95% CI, -1.07 to 1.08) RR=2.0 (95% CI, 1.01 to 3.95) in favor of modified open release ≤ 3mo: MD=.14 (95% CI, -.48 to .76) ≤ 3mo: OR=1.35 (95% CI, .71 to 2.55) >3mo: OR=1.00 (95% CI, .49 to 2.02)
Open (standard or modified) carpal tunnel release
Overall improvement
Symptom severity scale (Levine) Function status scale (Levine)
≤ 3mo: WMD= -.08 (95% CI, -.39 to .22) > 3mo: MD=.03 (95% CI, -.21 to .27) ≤ 3mo: WMD=-.16 (95% CI, -.60 to .29)
ACCEPTED MANUSCRIPT
RI PT
Pain
> 3mo: MD=.01 (95% CI, -.16 to .18) ≤ 3mo: WMD=-.18 (95% CI, -.96 to .59) OR=1.18 (95% CI, .50 to 2.78) > 3mo: MD=-5.20 (95% CI, -12.65 to 2.25) RR=.91 (95% CI, .39 to 2.14) ≤ 3mo: OR=1.12 (95% CI, .55 to 2.28) ≤ 3mo: WMD=.27 (95% CI, .02 to .53) in favor of two-portal endoscopic release > 3mo: MD=.76 (95% CI, -.32 to 1.84) > 3mo: OR=2.05 (95% CI, .74 to 5.69) ≤ 3mo: WMD= -.12 (95% CI, -.66 to .42) > 3mo: MD=.00 (95% CI, -.35 to .35) ≤ 3mo: WMD=-.25 (95% CI, -.82 to .32) > 3mo: MD=.0 (95% CI, -.29 to .29) ≤ 3mo: MD=-.31 (95% CI, -.63 to .02) OR=.06 (95% CI, .02 to .22) in favor of one-portal endoscopic release >3mo: OR=.80 (95% CI, .38 to 1.69) ≤ 3mo: OR=1.30 (95% CI, .62 to 2.71) > 3mo: MD=.06 (95% CI, -.04 to .16) OR=.60 (95% CI, .26 to 1.42) ≤ 3mo: WMD=.50 (95% CI, -.14 to 1.13) > 3mo: MD=1.28 (95% CI, .60 to 1.96) in favor of endoscopic release ≤ 3mo: RR=1.00 (95% CI, .83 to 1.20)
One-portal endoscopic carpal tunnel release
Open (standard or modified) carpal tunnel release
M AN U
SC
Numbness Grip strength
Overall improvement Symptom severity scale (Levine)
TE D
Function status scale (Levine)
EP
Pain
AC C
Numbness
Scholten et 16 al
2021
Open: modified
Open: standard
Grip strength
Overall improvement
ACCEPTED MANUSCRIPT
≤ 3mo: RR=1.02 (95% CI, .68 to 1.54) > 3mo: RR=.92 (95% CI, .74 to 1.14)
Overall improvement
After 3mo: RR=.93 (95% CI, .58 to 1.50) After 3mo: WMD=.00 (95% CI, .29 to .29) After 3mo: WMD=.10 (95% CI -.18 to .38)
RI PT
Overall improvement
SC
Placebo
≤ 3mo: OR=.76 (95% CI, .14 to 4.28)
Symptom severity score (Levine) Functional status score (Levine)
M AN U
1521
Postsurgical interventions Low-level laser
Overall improvement
Palmar pain Numbness
TE D
17
incision Open: without Knifelight instrument Open: without internal neurolysis Open: without epineurotomy Open: without tenosynovectomy
Paraesthesia Scar pain
EP
Peters et al (22 RCTs)
incision Open: with Knifelight instrument Open: with internal neurolysis Open: with epineurotomy Open: with tenosynovectomy
Pillar pain
Immobilisation (splint) Immobilisation (plaster or Paris splint)
AC C
(8 RCTs)
Mobilisation (bulky dressing) Bulky dressing and mobilisation
Symptom free Improved or cured Boston Carpal Tunnel Questionnaire, functional status score Boston Carpal Tunnel Questionnaire, symptom severity score
3mo: RR=.33 (95% CI, .01 to 7.86) 6mo: RR=1.0 (95% CI, .07 to 15.24) 3mo: RR=.14 (95% CI, .01 to 2.65) 6mo: RR=.2 (95% CI, .01 to 3.99) 3mo: RR=.14 (95% CI, .01 to 2.65) 6mo: RR=.2 (95% CI, .01 to 3.99) 3mo: RR=.33 (95% CI, .04 to 3.02) 6mo: RR=.33 (95% CI, .01 to 7.86) 3mo: RR=.67 (95% CI, .21 to 2.12) 6mo: RR=.33 (95% CI, .01 to 7.86) 6mo: RR=.94 (95% CI, .52 to 1.70) 6mo: RR=.90 (95% CI, .76 to 1.06) 3mo: MD=.39 (95% CI, -.45 to 1.23)
3mo: MD=1.60 (95% CI, -.12 to 3.32)
ACCEPTED MANUSCRIPT
Scar discomfort
6w: RR=.95 (95% CI, .59 to 1.54) 6mo: RR=1.19 (95% CI, .42 to 3.38) 1mo: RR=2.4 (95% CI, .99 to 5.81) 6wk: RR=1.25 (95% CI, .39 to 3.99) 6mo: RR=3.57 (95% CI, .39 to 32.87) 6wk: RR=2.5 (95% CI, .24 to 26.48) 6mo: RR=1.19 (95% CI, .08 to 18.36) 3mo: RR=5.0 (95% CI, .25 to 99.16)
RI PT
Pillar pain Hypothenar pain
Light dressing
Scar pain
Normal activities/ exercise
Disabilities of the Arm, Shoulder and Hand Grip strength Lateral pinch strength
TE D
Boston Carpal Tunnel Questionnaire, functional status score Boston Carpal Tunnel Questionnaire, symptom severity score Pain or discomfort
EP
Short duration dressing
No treatment
Extended duration dressing
AC C
Desensitization therapy (as part of multiple interventions)
6mo: MD=1.0 (95% CI, -4.44 to 6.44) 12wk: MD=-.60 (95% CI, -3.43 to 2.23) 6mo: MD=-.40 (95% CI, -3.59 to 2.79) 12wk: MD=-.20 (95% CI, -.97 to .57) 6mo: MD=-.20 (95% CI, -.94 to .54) 12wk: MD=-.03 (95% CI, -.39 to .33)
M AN U
Bulky dressing plus splint Multi-modal hand therapy
SC
Thenar pain
Grip strength Scar sensitivity Grip strength
Tip pinch strength
3-point pinch strength Lateral pinch strength
6wk: MD=.02 (95% CI, -.35 to .39)
12wk: MD=4.9 (95% CI, -14.69 to 24.49) 12wk: MD=-.80 (95% CI, -7.38 to 5.78) 12wk: MD=-.67 (95% CI, -1.46 to .12) 6 to 12wk: MD=-16.0 (95% CI, -21.57 to -10.43) in favor of short duration dressing 6 to 12wk: MD=-1.20 (95% CI, -2.35 to -.05) in favor of short duration dressing 6 to 12wk: MD=-1.10 (95% CI, -2.28 to .08) 6 to 12wk: MD=-.70 (95% CI, -1.88 to
ACCEPTED MANUSCRIPT
Continues ultrasound plus exercises
Laser therapy plus exercises
Continues ultrasound plus exercises
Exercises alone
Laser therapy plus exercises
Exercises alone
Disabilities of the Arm, Shoulder and Hand Pinch strength Pain
Pinch strength Pain
TE D
Pinch strength
AC C
EP
Pain
8wk: MD=-2.17 (95% CI, -4.59 to .25) 8wk: MD=1.94 (95% CI, .68 to 3.20) in favor of sensory retraining 8wk: MD=6.31 (95% CI, 1.14 to 11.48) in favor of sensory retraining 8wk: MD=-12.86 (95% CI, -30.91 to 5.19) 6wk: MD=1.40 (95% CI, .23 to 2.57) in favor of laser 6wk: MD=-.60 (95% CI, -1.05 to -.15) in favor of ultrasound 6wk: MD=4.0 (95% CI, 3.14 to 4.86) in favor of exercises 6wk: MD=-.1.80 (95% CI, -2.30 to -1.30) in favor of ultrasound 6wk: MD=2.60 (95% CI, 1.49 to 3.71) in favor of exercises 6wk: MD=-.1.20 (95% CI, -1.75 to -.65) in favor of laser
RI PT
Weinstein Enhanced Sensory Test 2-points discrimination Shape-Texture Identification test Locognosia test
SC
Control
M AN U
Sensory retraining programme
.48) 8wk: MD=.37 (95% CI, -.14 to .88)
ACCEPTED MANUSCRIPT
Appendix 2. Recent RCTs – CTS Treatment
Control/Comparison
Outcome Measures (Total Follow-Up Time)
Results Statistical
Non-surgical therapy: Local corticosteroid injection (n=83)
Nocturnal paraesthesias (VAS) (24mo) Diurnal pain (VAS) (24mo)
P<.001
Surgery: carpal tunnel release (n=20)
Non-surgical therapy: Local corticosteroid injection (n=20)
35
Surgery: carpal tunnel release, limited palmar incision technique (n=80)
Non-surgical therapy: Local corticosteroid injection (n=83)
P=.19
Surgical: mean ± SD, 1.29±7.26, vs nonsurgical: 3.04±6.54 at 24mo follow-up
P=.008
Surgical: mean ± SD, 2.02±7.23, vs nonsurgical: 6.21±8.81 at 24mo follow-up
Global Symptom score (12wk)
P=.794
Surgical: mean ± SD, 35.45000±7.43020, vs nonsurgical: 34.8000±8.14733 at baseline Surgical: mean ± SD, 12.5000±7.28011, vs nonsurgical: 11.6000±6.90080 at 2w follow-up Surgical: mean ± SD, 7.3000±5.67636, vs nonsurgical: 9.8500±6.39305 at 4wk follow-up Surgical: mean ± SD, 5.450±6.9014, vs nonsurgical: 22.100±6.8970 at 12wk follow-up
AC C
Andreu et al
Surgical: mean ± SD, 1.38±4.51, vs nonsurgical: 8.81±13.95 at 24mo follow-up
Self-perceived functional impairment (24mo)
EP
Ismatullah et 36 al
Surgery: Carpal tunnel release, limited palmar incision technique (n=80)
M AN U
34
TE D
Ly-Pen et al
SC
Surgical vs nonsurgical
Results by Outcome Measure
RI PT
Author
Functional impairment (VAS) (12mo)
P=.690
P=.190
P=.000
P=.793 P=.003
Surgical: mean ± SD, 39±28, vs nonsurgical: 38±26 at baseline Surgical: mean ± SD, 17±23, vs nonsurgical: 6±13 at 3mo follow-up
ACCEPTED MANUSCRIPT
P=.701
Pain (VAS)(12mo)
P=.951 P=.008
SC
P=.302
RI PT
P=.014
Surgical: mean ± SD, 7±15, vs nonsurgical: 8±15 at 6mo follow-up Surgical: mean ± SD, 3±11, vs nonsurgical: 9±15 at 12mo follow-up Surgical: mean ± SD, 42±30, vs nonsurgical: 42±29 at baseline Surgical: mean ± SD, 15±22, vs nonsurgical: 6±15 at 3mo follow-up Surgical: mean ± SD, 5±16, vs nonsurgical: 8±18 at 6mo follow-up Surgical: mean ± SD, 2±10, vs nonsurgical: 8±15 at 12mo follow-up Surgical: mean ± SD, 56±29, vs nonsurgical: 58±29 at baseline Surgical: mean ± SD, 16±25, vs nonsurgical: 8±17 at 3mo follow-up Surgical: mean ± SD, 7±17, vs nonsurgical: 13±21 at 6mo follow-up Surgical: mean ± SD, 3±11, vs nonsurgical: 12±19 at 12mo followup
M AN U
P=.018 Nocturnal paraesthesias (VAS) (12mo)
P=.584 P=.041
Splinting in neutral position with standard cotton-polyester, day and night for 3mo (group 1; n=23)
Local steroid injection into the carpal tunnel (20mg triamcinolone acetonide and 20mg lidocaine) after 3mo of splinting (group 2) (n=23)
Boston Questionnaire Symptom severity scale (6mo)
EP
25
AC C
Ucan et al
TE D
P=.060 P=.002
NS, no P value given
Group 1: from mean ± SD, 2.66±.35 at baseline to 1.39±0.37 at 3mo vs group 2: from 2.79±.63 at baseline to1.41±.32 at 3mo vs group 3: from 3.09±0.5 at baseline to1.86±0.6 at 3mo
P=.004
Group 1: from mean ± SD, 2.66±.35 to 1.54±.31 at 6mo vs group 2: from 2.79±.63 at baseline to 1.96±.63 at 6mo vs group 3*:3.09±0.5 at baseline to 1.41±.31 at 6mo Group 1: from mean ± SD,
Open carpal tunnel release (group 3; n=11)
BQ function capacity
NS, no P
ACCEPTED MANUSCRIPT
value given
Non-surgical therapy: Non-steroidal antiinflammatory drugs (ibuprofen 3 times daily 200mg) + hand therapy 6 sessions in 6wk + Splinting; ultrasound was offered in patient who did not improve at 6wk follow-up (n=59)
Pain intensity (12mo)
TE D
Surgery: open or endoscopic decompression of the carpal tunnel (n=57)
NS, no P value given P=.0993
Carpal Tunnel Syndrome Assessment Questionnaire Function score (12mo)
Surgical: mean ± SD, 6.6±2.6, vs nonsurgical: 6.8±2.5 at baseline Surgical: mean ± SD, 4.7±3.2, vs nonsurgical: 5.7±3.1 at 6mo followup Treatment effect (difference between groups): MD=1.0 (95% CI, -0.2 to 2.1)
P=.1590
Surgical: mean ± SD, 3.5 ± 3.0, vs nonsurgical: 4.3±3.3 at 12mo follow-up Treatment effect (difference between groups): MD=.90 (95% CI, -0.3 to 2.1)
NS, no P value given
Surgical: mean ± SD, 2.42±.82,vs nonsurgical: 2.53±.82 at baseline
EP
33
AC C
Jarvik et al
M AN U
SC
P=.03
2.47±.65 at baseline to 1.60±0.2 at 3mo vs group 2: from 2.19±.51 at baseline to 1.32±.33 at3mo vs group 3: from 2.7±.62 at baseline to 1.85 ±.63 at 3mo Group 1: from mean ± SD, 2.47±.65 at baseline to 1.75±.26 at 6mo vs group 2: from 2.19±.51 at baseline to 1.69±.31 at 6mo vs group 3*: from 2.7±.62 at baseline to1.52±.34 at 6mo
RI PT
scale (6mo)
ACCEPTED MANUSCRIPT
Surgical: mean ± SD, 1.74±.79, vs nonsurgical: 2.17±.96 at 12mo follow-up Treatment effect (difference between groups): MD=.40 (95% CI, .11 to .70)
M AN U
SC
P=.0081
Surgical: mean ± SD, 1.91±.88, vs nonsurgical: 2.44±.87 at 6mo followup Treatment effect (difference between groups): MD=.46 (95% CI, .20 to .72)
RI PT
P=0.006
NS, no P value given P=.0181
Carpal tunnel release (n=60)
AC C
Fernándezde-las-Peñas 32 et al
3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system
Mean level of hand pain (NPRS) (12mo)
Surgical: mean ± SD, 2.95±.77, vs nonsurgical: 3.01±.64 at baseline Surgical: mean ± SD, 2.02±1.03, vs nonsurgical: 2.42±.80 at 6mo follow-up Treatment effect (difference between groups): MD=.42 (95% CI, .07 to .77)
P=.0357
Surgical: mean ± SD, 1.74±.76, vs non-surgical: 2.07±.88 at 12mo follow-up Treatment effect (difference groups): MD=.34 (95% CI, .02 to .65)
NS, no P value given Significant, no P value given
Surgical: mean ± SD, 4.9±2.2, vs manual therapy: 4.8±1.5 at baseline
EP
TE D
Symptom score (12mo)
Surgical: mean ± SD, 2.5±2.1, vs manual therapy: 1.1±1.8 at 3mo follow-up
ACCEPTED MANUSCRIPT
Surgical: mean ± SD, 1.8±2.5, vs manual therapy: 1.1±1.6 at 6mo follow-up Surgical: mean ± SD, 1.3±1.9, vs manual therapy: 1.2±1.8 at 12mo follow-up Surgical: mean ± SD, 7.0±2.0, vs manual therapy: 6.6±1.7 at baseline
M AN U
SC
Worst level of hand pain (NPRS) (12mo)
NS, no P value given NS, no P value given NS, no P value given Significant, no P value given Significant, no P value given NS, no P value given NS, no P value given Significant, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no
RI PT
of 30 minutes duration, once per week (n=60)
AC C
EP
TE D
Boston Questionnaire Functional status scale (12mo)
Symptom severity
Surgical: mean ± SD, 4.3±3.0 vs manual therapy: 2.3±2.6 at 3mo follow-up Surgical: mean ± SD, 3.3±3.3, vs manual therapy: 2.2±2.5 at 6mo follow-up Surgical: mean ± SD, 2.7±1.9, vs manual therapy: 2.0±1.6 at 12mo follow-up Surgical: mean ± SD, 2.4±.6, vs manual therapy: 2.3±.5 at baseline Surgical: mean ± SD, 2.3±.7, vs manual therapy: 1.5±.4 at 1mo follow-up Surgical: mean ± SD, 1.8±.7, vs manual therapy: 1.5±.5 at 3mo follow-up Surgical: mean ± SD, 1.6±.6, vs manual therapy: 1.5±.5 at 6mo follow-up Surgical: mean ± SD, 1.5±.6, vs manual therapy: 1.5±.5 at 12mo follow-up Surgical: mean ± SD, 2.7±.6, vs
ACCEPTED MANUSCRIPT
manual therapy: 2.5±.7 at baseline Surgical: mean ± SD, 1.6±.4, vs manual therapy: 1.6±.6 at 3mo follow-up
RI PT
P value given NS, no P value given NS, no P value given NS, no P value given
Surgical: mean ± SD, 1.5±.5, vs manual therapy: 1.6±.6 at 6mo follow-up Surgical: mean ± SD, 1.5±.5, vs manual therapy: 1.5±.5 at 12mo follow-up
Symptom severity score (12.8y)
P=.79
Functional status score (12.8y)
P=.27
Pain (12.8y)
P=.54
TE D
Open carpal tunnel release (n=65)
EP
62
Disabilities of the Arm Shoulder and Hand (12.8y) Numbness and/or tingling (12.8y) Numbness and/or tingling, median nerve distribution Pain in scar or proximal palm (12.8y)
AC C
Atroshi et al
Various surgical techniques Endoscopic carpal tunnel release (n=63)
M AN U
SC
scale (12mo)
P=.82
P=.80 P=.75
P=.80
MD from baseline to mean (SD), 12.8 (1.2) y: -.03 (95% CI, -.25 to .19) MD from baseline to mean (SD), 12.8 (1.2) y= .11 (95% CI, -.09 to .31) MD from baseline to mean (SD), 12.8 (1.2) y= 1.5 (95% CI, -3.5 to 6.5) MD from baseline to mean (SD), 12.8 (1.2) y= -.7 (95% CI, -6.6 to 5.2) RR=.95 (95% CI, -3.5 to 6.5) at mean (SD) 12.8 (1.2) y follow-up RR=1.14 (95% CI, .52 to 2.48) at mean (SD) 12.8 (1.2) y follow-up
RR=.86 (95% CI, .28 to 2.67) at mean (SD) 12.8 (1.2) y follow-up
ACCEPTED MANUSCRIPT
Endoscopic carpal tunnel release (n=21)
Open carpal tunnel release (n=20)
Boston Questionnaire Symptom severity scale (6mo)
P=.39 P=.75
Functional status scale (6mo)
P=.17
Open carpal tunnel release (n=50)
Degree of improvement (12wk)
P=.08
Semmes-Weinstein monofilament test Two-point discrimination test Grip strength (kg)
P=.20
TE D
Endoscopic carpal tunnel release (Okutsu method) (n=51)
M AN U
23
Ejiri et al
EP
Tip pinch strength
Endoscopic carpal tunnel release (n=25)
AC C
Side pinch strength
Michelotti et 64 al
Open carpal tunnel release (n=25)
SC
P=.49
Carpal tunnel syndrome-Functional status score (24wk)
Endoscopic: mean ± SD, 3.35±.65, vs open: 3.51±0.54 at baseline Endoscopic: mean ± SD, 1.26±.48, vs open: 1.41±0.46 at 6mo follow-up Endoscopic: mean ± SD, 3.11±.82, vs open: 3.43±0.63 at baseline Endoscopic: mean ± SD, 1.20±.35, vs open: 1.56±0.48 at 6mo follow-up
RI PT
Gümüstas et 63 al
P=.79 P=.04 P=.27 P=.09 P=.01 P=.07
P=.68 P=.29 P=.92
Endoscopic: improved/unchanged/ exacerbated, 47/2/1, versus open: 50/0/0 at 12wk follow-up Endoscopic: MD from baseline to 12w, -.49, versus open -.24 Endoscopic: MD from baseline to 12w, -3.3, versus open -1.7 Endoscopic: MD from baseline to 4wk, -4.60, versus open -8.10 Endoscopic: MD from baseline to 12wk, -1.20, versus open -3.60 Endoscopic: MD from baseline to 12wk, .07, versus open -.2 Endoscopic: MD from baseline to 4wk, .3, versus open -.8 Endoscopic: MD from baseline to 12wk, .7, versus open -.2 Endoscopic: mean, 2.27, vs open: 2.18 at baseline Endoscopic: mean, 1.18, vs open: 1.23 at 12wk follow-up Endoscopic: mean, 1.13, vs open:
ACCEPTED MANUSCRIPT
P=.32 P=.32 P=.76 P=.65
SC
Pain (VAS) (24wk)
RI PT
Carpal tunnel syndrome-Symptom severity score (24wk)
1.14 at 24wk follow-up Endoscopic: mean, 2.66, vs open: 2.50 at baseline Endoscopic: mean, 1.23, vs open: 1.28 at 12wk follow-up Endoscopic: mean, 1.21, vs open: 1.19 at 24w follow-up Endoscopic: mean, 1.33, vs open: 1.06 at baseline Endoscopic: mean, .40, vs open: .26 at 12wk follow-up Endoscopic: mean, .23, vs open: .19 at 24wk follow-up Endoscopic: mean, 6.92, vs open: 6.60 at baseline Endoscopic: mean, 5.13, vs open: 4.91 at 12wk follow-up Endoscopic: mean, 5.11, vs open: 4.71 at 24wk follow-up Endoscopic: mean, 3.64, vs open: 3.78 at baseline Endoscopic: mean, 3.06, vs open: 3.20 at 12wk follow-up Endoscopic: mean, 3.07, vs open: 3.11 at 24wk follow-up Endoscopic: mean, 4.50, vs open: 4.52 at baseline Endoscopic: mean, 4.87, vs open: 4.86 at 12wk follow-up Endoscopic: mean, 4.89, vs open: 4.90 at 24wk follow-up Endoscopic: mean, 15.20, vs open: 16.56 at baseline Endoscopic: mean, 15.33, vs open:
P=.29
M AN U
P=.44
Two-point discrimination test (24wk)
P=.71 P=.34
TE D
P=.24
EP
Semmes-Weinstein monofilament testing (24wk)
AC C
Abductor pollicis brevis strength (24wk)
Grip strength (24wk)
P=.38 P=.40 P=.79 P=.91 P=.91 P=.96 P=.55 P=.52
ACCEPTED MANUSCRIPT
14.09 at 12wk follow-up Endoscopic: mean, 15.79, vs open: 15.81 at 24wk follow-up
22
Group 1: Endoscopic carpal tunnel release (n=32)
Group 2: Regular open carpal tunnel release (n=36)
Night pain (4mo)
Numbness (4mo) Group 3: Mid-palmar mini incision (n=28)
M AN U
Stiffness (4mo)
NS, no P value given NS, no P value given NS, no P value given NS, no P value given P<.05
Wrist pain (4mo)
TE D
Weakness (4mo)
Zhang et al
65
Group 1: subneural reconstruction of the transverse carpal ligament (n=68)
AC C
EP
Grip strength (4mo) Pain (4mo)
Group 2: isolated open carpal tunnel release (n=92) Group 3: endoscopic carpal tunnel release
Boston carpal tunnel Questionnaire Symptom severity scale (24mo)
Group 1: 0/32, versus group 2: 0/36, versus group 3: 0/28 at 4mo follow up Group 1: 0/32, versus group 2: 0/36, versus group 3: 0/28 at 4mo follow up Group 1: 4/32, versus group 2: 2/36, versus group 3: 0/28 at 4mo follow up Group 1: 4/32, versus group 2: 0/36, versus group 3: 4/28 at 4mo follow up Group 1: 2/32, versus group 2: 4/36, versus group 3: 0/28, in favor of group 1 and group 3 versus group 2 at 4mo follow up No data given at 4mo follow-up No data given, but in favor of group 1 and group 3 versus group 2 at 4w follow-up No data given at 4mo follow-up
SC
Aslani et al
RI PT
P=.99
P<.05 P<.05
NS, no P value given
Group 1-2: P=.084 Group 1-3: P=.204
Group 1: mean ± SD, 39.5±6.1, vs group 2: 37.5±6.1, vs group 3: 38±6.1 at baseline
ACCEPTED MANUSCRIPT
Group 1: mean ± SD, 13.4±8.4, vs group 2: 14.2±9.5, vs group 3: 13.9±10.8 at 3mo follow-up
RI PT
Group 2-3: P=.457 Group 1-2: P=.206 Group 1-3: P=.674 Group 2-3: P=.739 Group 1-2: P=.264 Group 1-3: P=.777 Group 2-3: P=.773 Group 1-2: P=.336 Group 1-3: P=.381 Group 2-3: P=.520 Group 1-2: P=.267 Group 1-3: P=.423 Group 2-3: P=.329 Group 1-2: P=.114 Group 1-3: P=.612 Group 2-3: P=.082 Group 1-2: P=.001
Group 1: mean ± SD, 6.4±5.6, vs group 2: 6.2±5.2, vs group 3: 5.7±6.4 at 6mo follow-up
AC C
EP
TE D
M AN U
SC
(n=53)
Function status scale (24mo)
Group 1: mean ± SD, 5.1±5.7, vs group 2: 4.9±4.2, vs group 3: 4.8±4.1 at 12mo follow-up
Group 1: mean ± SD, 4.3±5.0, vs group 2: 4.4±5.5, vs group 3: 4.7±5.6 at 24mo follow-up
Group 1: mean ± SD, 27.3±6.6, vs group 2: 26.6±7.3, vs group 3: 28.6±5.5 at baseline
Group 1: mean ± SD, 5.1±3.9, vs group 2: 9.3±7.5, vs group 3:
ACCEPTED MANUSCRIPT
RI PT
6.8±5.2 at 3mo follow-up
Group 1: mean ± SD, 4.5±3.7, vs group 2: 6.9±6.6, vs group 3: 6.2±6.3 at 6mo follow-up
TE D
M AN U
SC
Group 1-3: P=.030 Group 2-3: P=.045 Group 1-2: P=.001 Group 1-3: P=.026 Group 2-3: P=.231 Group 1-2: P=.003 Group 1-3: P=.031 Group 2-3: P=.452 Group 1-2: P=.015 Group 1-3: P=.001 Group 2-3: P=.248 Group 1-2: P=.905 Group 1-3: P=.490 Group 2-3: P=.273 Group 1-2: P=.001 Group 1-3: P=.001 Group 2-3: P=.169
AC C
EP
Cylindrical grip strength
Group 1: mean ± SD, 3.5±2.9, vs group 2: 6.5±5.8, vs group 3: 6.8±5.1 at 12mo follow-up
Group 1: mean ± SD, 3.3±3.6, vs group 2: 6.8±5.2, vs group 3: 6.2±6.5 at 24mo follow-up
Group 1: mean ± SD, 71.8±17.5, vs group 2: 73±17.5, vs group 3: 74.6±15.8 at baseline
Group 1: mean ± SD, 74.7±14.5, vs group 2: 84.4±13.7, vs group 3: 87.2±13.5 at 3mo follow-up
ACCEPTED MANUSCRIPT
RI PT
Group 1: mean ± SD, 87.9±12.1, vs group 2: 87.4±12.8, vs group 3: 89.9±12.2 at 6mo follow-up
Group 1: mean ± SD, 95.7±14.6, vs group 2: 88.2±10.9, vs group 3: 87.4±14.1 at 12mo follow-up
M AN U
SC
Group 1-2: P=.001 Group 1-3: P=.009 Group 2-3: P=.367 Group 1-2: P=.015 Group 1-3: P=.032 Group 2-3: P=.451 Group 1-2: P=.002 Group 1-3: P=.001 Group 2-3: P=.347 Group 1-2: P=.352 Group 1-3: P=.477 Group 2-3: P=.087 Group 1-2: P=.255 Group 1-3: P=.374 Group 2-3: P=.786 Group 1-2: P=.427 Group 1-3: P=.126
AC C
EP
TE D
Lateral grip strength (24mo)
Group 1: mean ± SD, 96.1±18.2, vs group 2: 87±15.7, vs group 3: 86.9±17.6 at 24mo follow-up
Group 1: mean ± SD, 76.8±13.4, vs group 2: 78±17.6, vs group 3: 72.3±16.3 at baseline
Group 1: mean ± SD, 82.8±18.1, vs group 2: 85.7±19.5, vs group 3: 84.9±15 at 3mo follow-up
Group 1: mean ± SD, 86.7±12.8, vs group 2: 84.9±18.4, vs group 3: 86.5±13.6 at 6mo follow-up
ACCEPTED MANUSCRIPT
RI PT
Group 1: mean ± SD, 92.2±16.5, vs group 2: 89.7±17.4, vs group 3: 88.5±10.9 at 12mo follow-up
Group 1: mean ± SD, 97.6±12.4, vs group 2: 88.4±18.3, vs group 3: 92.5±12.5 at 24mo follow-up
M AN U
SC
Group 2-3: P=.352 Group 1-2: P=.250 Group 1-3: P=.293 Group 2-3: P=.224 Group 1-2: P=.754 Group 1-3: P=.329 Group 2-3: P=.128 Group 1-2: P=.266 Group 1-3: P=.753 Group 2-3: P=.182 Group 1-2: P=.525 Group 1-3: P=.094 Group 2-3: P=.007 Group 1-2: P=.004 Group 1-3: P=.008 Group 2-3: P=.269 Group 1-2: P=.012
AC C
EP
TE D
Pinch grip strength (24mo)
Group 1: mean ± SD, 75.8±16.3, vs group 2: 73±23.1, vs group 3: 76.3±15.3 at baseline
Group 1: mean ± SD, 77.4±16.4, vs group 2: 75.5±18.1, vs group 3: 78.3±12.9 at 3mo follow-up
Group 1: mean ± SD, 95±16.4, vs group 2: 82.3±22.2, vs group 3: 80.7±16.5 at 6mo follow-up
Group 1: mean ± SD, 96.5±17.3, vs group 2: 80.8±17.7, vs group 3:
ACCEPTED MANUSCRIPT
RI PT
82.5±12.4 at 12mo follow-up
Kang et al
24
Endoscopic carpal tunnel release (n=52)
AC C
EP
TE D Mini-incision carpal tunnel release (n=52)
Boston carpal tunnel Questionnaire Symptom severity scale (3mo)
Group 1: mean ± SD, 96.1±17.3, vs group 2: 81.5±17.8, vs group 3: 84.3±16.1 at 24mo follow-up
SC
M AN U
Michigan Hand Outcome (24mo)
Group 1-3: P=.032 Group 2-3: P=.531 Group 1-2: P=.006 Group 1-3: P=.025 Group 2-3: P=.392 Group 1-2: P=.478 Group 1-3: P=.216 Group 2-3: P=.321 Group 1-2: P=.002 Group 1-3: P=.012 Group 2-3: P=.006 Group 1-2: P=.001 Group 1-3: P=.001 Group 2-3: P=.001
No P value given
Group 1: mean ± SD, 45.2±14.4, vs group 2: 48.5±15.9, vs group 3: 43.2±12.1 at baseline
Group 1: mean ± SD, 89.5±12.6, vs group 2: 76.3±21.6, vs group 3: 81.5±14.8 at 12mo follow-up
Group 1: mean ± SD, 91.2±7.2, vs group 2 84.4±8.4, vs group 3: 86.2±7.6 at 24mo follow-up
Endoscopic: mean, 3.3 (95% CI, 3.1 to 3.5), vs mini-incision: 3.3 (95% CI, 3.1 to 3.5) at baseline
ACCEPTED MANUSCRIPT
Functional status scale (3mo)
P=.774 No P value given
P=.832 No P value given
M AN U
Disabilities of the Arm Shoulder and Hand (3mo)
SC
No P value given
No P value given
Group 2: Open carpal tunnel release (classic incision) (n=30)
Pain (VAS)
EP
Group 1: Endoscopic carpal tunnel release (n=30)
Group 3: Open carpal tunnel release (short incision) (n=30)
AC C
69
TE D
P=.978
Larsen et al
Paraesthesia (VAS)
Endoscopic: mean, 1.5 (95% CI, 1.4 to 1.6), vs mini-incision: 1.4 (95% CI, 1.4 to 1.6) at 3mo follow-up MD at 3mo: no exact data given Endoscopic: mean, 2.8 (95% CI, 2.6 to 3.1), vs mini-incision: 3.0 (95% CI, 2.6 to 3.0) at baseline Endoscopic: mean, 1.5 (95% CI, 1.4 to 1.6), vs mini-incision: 1.7 (95% CI, 1.3 to 1.5) at 3mo follow-up MD at 3mo: no exact data given Endoscopic: mean, 48 (95% CI, 44 to 53), vs mini-incision: 48 (95% CI, 43 to 52) at baseline Endoscopic: mean, 11 (95% CI, 9 to 14), vs mini-incision: 11 (95% CI, 8 to 14) at 3mo follow-up MD at 3mo: no exact data given
RI PT
No P value given
No P value given NS, no P value given NS, no P value given No P value given NS, no P value given NS, no P value
No exact data given at baseline No exact data given at 12w followup No exact data given at 24w followup No exact data given at baseline No exact data given at 12w followup No exact data given at 24w followup
ACCEPTED MANUSCRIPT
74
Heidarian et 75 al
Tarallo et al
82
Carpal tunnel release using a Knifelight (n=39)
Open carpal tunnel release (n=43)
Quick Disabilities of the Arm Shoulder and Hand (10y)
Knifelight surgery (n=29)
Standard open carpal tunnel release (n=30)
Pain (VAS) (3wk)
Minimal access
Standard open carpal
Boston carpal tunnel
AC C
Elsharif et al
EP
TE D
RI PT
M AN U
Grip strength
No exact data given, but significant in favor of group 1 versus group 2 and group 3 at 3w follow- up No exact data given at 12w followup No exact data given at 24w followup
SC
Range of motion
given Significant, no P value given NS, no P value given NS, no P value given Significant, no P value given Significant, no P value given Significant, no P value given NS, no P value given
No exact data given, but significant in favor of group 1 versus group 2 and group 3 at 3w follow- up No exact data given, but significant in favor of group 1 and group 2 versus group 3 at 6w follow- up No exact data given, but significant in favor of group1 and group 2 versus group 3 at 12w follow- up No exact data given at 24w followup
P=.0024
Knifelight: mean ± SD, 13.22±13.62, vs open: 34.10 ± 23.27 at 10y follow-up
P=.24
Knifelight: mean ± SD (95% CI), 1.38±1.08 (1 to 1.8), vs standard: 1.80±1.58 (1.2 to 2.4) at 3wk follow-up
ACCEPTED MANUSCRIPT
tunnel release (n=60)
Questionnaire Symptom severity scale (12mo)
NS, no P value given P<.001
TE D
Standard CTD (n=42)
Scar pain scores
EP
Nerve-preserving CTD (n=42)
AC C
Siegmeth and Hopkinson83 Woolley
PEM score, second part (i.e., outcome, range 1-7)
Minimal access: mean ± SD, 1.1±.1 vs standard CTR: 1.6±.4 at 12mo follow-up
NS, no P value given P<.001
Minimal access: mean ± SD, 3.7±.3 vs standard CTR: 3.6±.4 at baseline
P<.001
Minimal access: mean ± SD, 1.1±.1 vs standard CTR: 1.5±.2 at 12mo follow-up
P=.59
3mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 6mo after surgery: no differences between nervepreserving CTS and standard CTD (no data given) 3mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 6mo after surgery: no differences between nerve- preserving CTS and standard CTD (no data given)
M AN U
Functional status scale (12mo)
Minimal access: mean ± SD, 1.4±.3 vs standard CTR: 2.7±.6 at 6mo follow-up
SC
P<.001
Minimal access: mean ± SD, 3.9±.4 vs standard CTR: 3.8±.5 at baseline
RI PT
carpal tunnel release (n=60)
P=.38
P=.43
P=.13
Minimal access: mean ± SD, 1.4±.4 vs standard CTR: 2.3±.6 at 6mo follow-up
ACCEPTED MANUSCRIPT
Open carpal tunnel release with preservation of the parietal layer of the ulnar bursa beneath the flexor retinaculum (n=53)
Open carpal tunnel release with division of the parietal layer of the ulnar bursa beneath the flexor retinaculum (n=58)
Grip strength (9wk)
Preservation of ulnar bursa: mean ± SD, 4.1±.32 at baseline to mean (95% CI),13.2 (10.7 to 15.7) at 9wk follow-up vs division of ulnar bursa:
P=.661
RI PT
Forward et 84 al
20.0±1.7 at baseline to 14.7 (11.3 to 18.2) at 9 wk follow-up
P=.990
Preservation of ulnar bursa: mean ± SD, 54±0.3 at baseline to mean (95% CI), 26 (21 to 32) at 9 wk follow-up vs division
Crnković et 94 al
Decompression of the median nerve by open carpal tunnel release without perineural corticosteroid injection (n=20)
Open carpal tunnel release followed by longitudinal epineurotomy (n=25)
Standard open carpal tunnel release (n=25)
Disappearance of symptoms (%; 90d)
Grip strength (kg) (180d)
Pain (VAS) (180d)
of ulnar bursa: 57±0.3 at baseline to 25 (20 to 30) at 9wk follow-up
No P value given
Treatment group: 77.5% 7d after treatment and 97.5% 90d after treatment vs controls: 75% 7d after treatment and 95% 90d after treatment #
NS, no P value given NS, no P value given NS, no P value given P=.271
CTR with epineurtomy: mean, 21.5, vs standard CTR: 23 at baseline
TE D
Decompression of the median nerve by open carpal tunnel release with perineural injection of 1mL betamethasone immediately after decompression (n=20)
EP
85
AC C
Stepic et al
M AN U
SC
Patient evaluation Measure score (9wk)
CTR with epineurtomy: mean, 21, vs standard CTR: 19.5 at 90d follow-up CTR with epineurtomy: mean, 22, vs standard CTR: 24 at 180d follow-up Difference between groups (95%
ACCEPTED MANUSCRIPT
Group 2: Standard open carpal tunnel release (n=15 hands)
Levine's symptom Severity score (3mo)
P=0.38
Levine's Functional score (3mo)
P=0.9693
P=0.474
Group 1: mean ± SD, 52±6.49, vs group 2: 50.3 ± 6.11 at 1mo follow-up
P=0.004
Group 1: mean ± SD, 62.67±5.62, vs group 2: 55.67 ± 6.51 at 3mo follow-up
Pinch strength (pounds) (3mo)
P=0.79
2-point discrimination test (3mo)
P=0.28
Group 1: mean ± SD, 13.6±1.84, vs group 2: 12.47 ± 1.55 at 3mo follow-up Group 1: mean, 3.28, vs group 2: 3.04 at baseline
TE D EP Group 1: Carpal tunnel release with short wrist transverse
Group 2: Carpal tunnel release with limited open technique (n=42)
Group 1: mean ± SD, 1.17±0.17, vs group 2: 1.23 ± 1.95 at 3mo follow-up Group 1: mean, 2.946, vs group 2: 2.956 at baseline Group 1: mean ± SD, 1.28±0.31, vs group 2: 1.45 ± 0.5 at 3mo follow-up
AC C 93
Group 1: mean, 3.2, vs group 2: 2.87 at baseline
P=0.29
Grip strength (pounds) (3mo)
Cho et al
P=0.3186
SC
Group 1: Limited open carpal tunnel release using direct vision plus tunneling technique (n=15 hands)
M AN U
Suppaphol et 92 al
RI PT
P=.017
CI): .62 (-.50 to 1.73) in favour of standard CTR at 90d follow-up Difference between groups (95% CI): 1.38 (.26 to 2.49) in favour of standard CTR at 180d follow-up
Brigham and Women's carpal tunnel Questionnaire
P=0.63
Group 1: mean ± SD, 2.75±0.62, vs group 2: 2.63 ± 0.69 at 3mo follow-up
ACCEPTED MANUSCRIPT
open technique (n=42)
Symptom severity scale (2y)
P=.56
P=.38 Functional status scale (2y)
P=.44
SC
P=.58
RI PT
P=.36
Group 1: mean, 3.80 vs group 2: 3.78 at baseline Group 1: mean, 1.62 vs group 2: 1.64 at 1y follow-up Group 1: mean, 1.48 vs group 2: 1.50 at 2y follow-up Group 1: mean, 3.83 vs group 2: 3.82 at baseline Group 1: mean, 1.65 vs group 2: 1.68 at 1y follow-up Group 1: mean, 1.53 vs group 2: 1.56 at 2y follow-up Group 1 (%): 26/39 (67%) vs group 2: 29/40 (72%) at 3mo follow-up Group 1 (%): 13/39 (33%) vs group 2: 14/40 (35%) at 6mo follow-up Group 1 (%): 2/39 (5%) vs group 2: 5/40 (2%) at 1y follow-up Group 1 (%): 1/39 (3%) vs group 2: 1/40 (3%) at 2y follow-up
M AN U
P=.39 Scar discomfort (2y)
P=.32 P=.24
Transverse carpal ligament releasing with distal forearm fascia releasing (n=80)
Transverse carpal ligament releasing (n=79)
Pain (VAS) (24mo)
EP
96
AC C
Acar et al
TE D
P=.38
Hamed et al
98
Open carpal tunnel decompression using a double-incision
Open carpal tunnel decompression using the standard single-
P=.58
P=.120 P=.120
Night-time paraesthesia, positive (24mo)
P=.120
Pillar pain (6mo)
P=0.04
P=.107
TCL+DFFR: mean ± SD, 6.52±2.70, vs TCL, 7.13±2.23 at baseline TCL+DFFR: mean ± SD, 1.26±2.38, vs TCL, 1.00±2.09 at 24mo follow-up TCL+DFFR: 100%, vs TCL 92.2% at baseline TCL+DFFR: 100%, vs TCL 0% at 24mo follow-up Number of wrists with pillar pain: double incision: 4/19 vs single incision:12/21 at 3mo follow-up
ACCEPTED MANUSCRIPT
incision technique (n=21) Grip strength (6mo)
P=0.03
Number of wrists with pillar pain: double incision: 1/19 vs single incision: 8/21 at 6mo follow-up
P=1.0
Double incision: mean ± SD, 46±10, vs single incision: 46±8 at baseline Double incision: mean ± SD, 65±12, vs single incision: 61±10 at 3mo follow-up
P=0.25
Double incision: mean ± SD, 70±16, vs single incision: 65±16 at 6mo follow-up
Brigham and Women's carpal tunnel Questionnaire Symptom severity scale (6mo+)
TE D
Standard open carpal tunnel release (n=16)
EP
Two-incision carpal tunnel release (n=14)
Functional status scale (6mo+)
AC C
Castillo and 95 Yao
M AN U
SC
P=0.45
RI PT
technique (n=19)
Disabilities of the Arm
P=0.58
P=0.61
P=0.09
P=0.72
P=0.69
P=0.35
P=0.61
Two-incision: mean ± SD, 2.91±.59, vs standard CTR: 2.84±.77 at baseline Two-incision: mean ± SD, 1.89±.77, vs standard CTR: 2.27±1.58 at 6w follow-up Two-incision: mean ± SD, 1.33±.53, vs standard CTR: 1.33±.36 at 6mo+ follow-up Two-incision: mean ± SD, 2.54±.75, vs standard CTR: 2.39±.97 at baseline Two-incision: mean ± SD, 2.10±1.06, vs standard CTR: 2.08±.79 at 6wk follow-up Two-incision: mean ± SD, 1.60±.87, vs standard CTR: 1.57±.88 at 6mo+ follow-up Two-incision: mean ± SD,
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Shoulder and Hand Questionnaire (6mo+)
P=0.11
SC
P=0.92
P=0.33
Two-incision: mean ± SD, .0±0, vs standard CTR: .13±.50 at 6mo+ follow-up
P=0.35
Two-incision: mean ± SD, 1.18±2.44, vs standard CTR: .25±.87 at 6wk follow-up Two-incision: mean ± SD, .0±0, vs standard CTR: .56±1.55 at 6mo+ follow-up
M AN U
Scar tenderness (6mo+)
RI PT
P=0.83
Radial pillar pain (6mo+)
TE D
P=0.65
AC C
EP
Ulnar pillar pain (6mo+)
Grip strength (lb) (6mo+)
35.80±14.23, vs standard CTR: 41.96±24.10 at baseline Two-incision: mean ± SD, 30.48±25.49, vs standard CTR: 26.68±18.83 at 6wk follow-up Two-incision: mean ± SD, 13.50±22.46, vs standard CTR: 13.22±20.63 at 6mo+ follow-up Two-incision: mean ± SD, .45±.93, vs standard CTR: .42±.90 at 6wk follow-up
P=0.55
Two-incision: mean ± SD, .36±.67, vs standard CTR: .83±1.40 at 6wk follow-up
P=0.49
Two-incision: mean ± SD, .0±0, vs standard CTR: .94±2.05 at 6mo+ follow-up
P=0.45
Two-incision: mean ± SD, 44.53±23.13, vs standard CTR: 36.16±21.20 at baseline Two-incision: mean ± SD, 26.18±13.12, vs standard CTR: 37.46±21.84 at 6wk follow-up Two-incision: mean ± SD, 43.60±14.15, vs standard
P=0.28
P=1.00
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CTR: 42.81±22.15 at 6mo+ follow-up P=0.34
P=0.55
TE D
M AN U
Change in SemmesWeinstein monofilament scores Thumb (6mo+)
SC
P=0.07
AC C
EP
Second finger (6mo+)
Third finger (6mo+)
Vanni et al
99
Double tunnels
Standard open
Boston carpal tunnel
Two-incision: mean ± SD, 17.85±12.68, vs standard CTR: 12.00±5.83 at baseline Two-incision: mean ± SD, 13.64±4.27, vs standard CTR: 12.08±5.23 at 6wk follow-up Two-incision: mean ± SD, 16.60±3.27, vs standard CTR: 12.25±6.04 at 6mo+ follow-up
RI PT
Pinch strength (lb) (6mo+)
P=0.75
Two-incision: mean ± SD, -.18±.60, vs standard CTR: -.17±.83 at 6wk follow-up
P=0.53
Two-incision: mean ± SD, -.20±.63, vs standard CTR: -.38±.72 at 6mo+ follow-up
P=0.03
Two-incision: mean ± SD, -.18±.40, vs standard CTR: -.67±.49 at 6wk follow-up
P=0.09
Two-incision: mean ± SD, -.10±.32, vs standard CTR: -.56±.51 at 6mo+ follow-up
P=0.22
Two-incision: mean ± SD, -.36±.50, vs standard CTR: -.67±.49 at 6wk follow-up
P=0.04
Two-incision: mean ± SD, .0±.50, vs standard CTR: -.69±.60 at 6mo+ follow-up
No P value
Double tunnels: mean ± SD, 2.1±1.1
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decompression of the median nerve (n=110)
Questionnaire (12mo)
given
vs standard CTR: 8.3±3.8 at 3mo follow-up
No P value given
Double tunnels: mean ± SD, .8±0.1 vs standard CTR: 8.1±1.2 at 6mo follow up
P<.05
P<.05
Double tunnels: mean ± SD, .1±.03 vs standard CTR: 1.9±.9 at 12mo follow up Double tunnels: mean ± SD, 2.1±.5 vs standard CTR: 4.9±.5 at 12mo follow up
Pain (VAS) (3mo)
P=.5
Grip strength (3mo)
P=.5
Pinch grip (3mo)
P=.6
Levine-Katz questionnaire Symptoms (3 mo, 7y)
P=.6
TE D
Carpal tunnel decompression using the standard limited palmar open incision (n=100)
EP
Carpal tunnel decompression using the Biomet TM Indiana Tome (mini open technique; n=100)
AC C
Cresswell et 97 al
M AN U
SC
Pain (VAS) (12mo)
RI PT
technique (n=110)
Levine-Katz questionnaire Function (3mo, 7y)
P<.05 P=.7
P=.2
TM Indiana Tome: 1.9 (mean) at 3mo vs open incision: 2.0 at 3mo follow-up TM Indiana Tome: 96% (mean) at 3mo vs open incision: 94% at 3mo follow-up TM Indiana Tome: 93% (mean) at 3mo vs open incision: 89% at 3mo follow-up TM Indiana Tome: from 17.8 (mean) preoperative to 18.5 at 3mo vs open incision: from 19.3 preoperative to 17.1 at 3mo follow-up TM Indiana Tome*: 16.0 (mean) vs open incision: 13 at 7y follow-up TM Indiana Tome: from 33.9 (mean) preoperative to18.5 at 3mo vs open incision: from 34.5 preoperative to 19.8 at 3mo follow-up TM Indiana Tome: 12 (mean) vs open incision: 10 at 7y follow-up
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100
Carpal tunnel release, incision distal to the flexor crease (n=45)
Carpal tunnel release, incision proximal to the flexor crease (n=45)
Boston carpal tunnel Questionnaire Symptom severity scale (1mo)
NS, no P value given
mean ± SD, 3.27±.72 vs incision proximal to the flexor crease: 3.38±.76 at baseline Incision distal to the flexor crease:
mean ± SD, 2.41±.75 vs incision proximal to the flexor crease:
SC
NS, no P value given
Incision distal to the flexor crease:
RI PT
Uçar et al
M AN U
NS, no P value given
AC C
EP
TE D
Function status scale (1mo)
Xu et al
101
Coronal Z-type lengthening of transverse carpal
Standard open approach surgery (n=28)
Grip strength (kg) (12mo)
NS, no P value given NS, no P value given NS, no P value given
2.65±.76 at 1mo follow-up Incision distal to the flexor crease:
mean ± SD, 2.42±.75 at (mean ± SD) 30.4 ± 15.0 vs incision proximal to the flexor crease: 2.16±.68 at (mean ± SD) 31.0±15.3 at 1mo follow-up Incision distal to the flexor crease:
mean ± SD, 3.10±.70 vs incision proximal to the flexor crease: 3.13±.76 at baseline Incision distal to the flexor crease: mean ± SD, 2.14±.69 vs incision proximal to the flexor crease: 2.19±.75 at 1mo follow-up Incision distal to the flexor crease: mean ± SD, 2.66±.74 at (mean ± SD) 30.4 ± 15.0 mo vs incision proximal to the flexor crease: 2.21±.73 at (mean ± SD) 31.0±15.3 mo
No P value given
Z-type lengthening: mean ± SD, 7±1.1, vs standard open approach: 4.5±1.5 at baseline
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Z-type lengthening: mean ± SD, 20.8±1.4, vs standard open approach: 19.2±1.2 at 3mo follow-up
P=.01
Z-type lengthening: mean ± SD, 39.6±7.5, vs standard open approach: 21.4±6.2 at 6mo follow-up Z-type lengthening: mean ± SD, 38.4±6.4, vs standard open approach: 22.6±4.5 at 12mo follow-up
M AN U
SC
P=.01
RI PT
P=.05
ligament (n=30)
Post-operative treatment
Pain (VAS) (6mo)
TE D
Soft bulky dressing after limited open carpal tunnel release (n=14)
2-point discrimination test radial side of the index finger (6mo)
EP
Splint after limited open carpal tunnel release for 1w (n=16)
AC C
Shalimar et 124 al
Ulnar side of the index finger (6mo)
NS, no P value given NS, no P value given NS, no P value given
Splint: mean ± SD, 4.7±2.0, vs no splint: 5.6±2.3 at baseline Splint: mean ± SD, 1.3±1.8, vs no splint: 1.4±1.8 at 2mo Splint: mean ± SD, .1±.3, vs no splint: .4±1.3 at 6mo
NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P
Splint: mean ± SD, 7.0±3.7, vs no splint: 6.4±2.0 at baseline Splint: mean ± SD, 5.0±1.0, vs no splint: 5.6±1.4 at 2mo Splint: mean ± SD, 4.3±1.0, vs no splint: 4.7±.7 at 6mo Splint: mean ± SD, 5.8±1.6, vs no splint: 6.2±1.6 at baseline Splint: mean ± SD, 4.8±.5, vs no splint: 5.6±1.3 at 2mo Splint: mean ± SD, 4.3±1.0, vs no
ACCEPTED MANUSCRIPT
M AN U
SC
Grip strength (6mo)
splint: 5.3±2.1 at 6mo Splint: mean ± SD, 4.9±2.0, vs no splint: 4.5±1.5 at baseline Splint: mean ± SD, 4.3±1.5, vs no splint: 5.1±1.4 at 2mo Splint: mean ± SD, 6.0±2.4, vs no splint: 6.2±1.9 at 6mo Splint: mean ± SD, 18.4±8.2, vs no splint: 18.9±4.5 at baseline Splint: mean ± SD, 16.3±6.9, vs no splint: 18.5±4.9 at 2mo Splint: mean ± SD, 21.4±8.5, vs no splint: 22.9±5.6 at 6mo Splint: mean ± SD, 3.9±.7, vs no splint: 3.7±1.1 at baseline Splint: mean ± SD, 4.1±.4, vs no splint: 4.1±.4 at 2mo Splint: mean ± SD, 4.5±1.1, vs no splint: 4.4±1.1 at 6mo
RI PT
Pinch strength (6mo)
value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given
TE D
Power grade abductor pollicis brevis (6mo)
AC C
EP
Boston Questionnaire Symptom Severity scale (6mo)
Functional status scale (6mo)
Scar pain (6mo)
NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given P=.53
Splint: mean ± SD, 2.6±.7, vs no splint: 2.5±.5 at baseline Splint: mean ± SD, 1.2±.2, vs no splint: 1.4±.3 at 2mo Splint: mean ± SD, 1.0±.0, vs no splint: 1.1±.3 at 6mo Splint: mean ± SD, 2.9±.5, vs no splint: 2.8±.8 at baseline Splint: mean ± SD, 1.5±.5, vs no splint: 1.4±.5 at 2mo Splint: mean ± SD, 1.0±.1, vs no splint: 1.0±.4 at 6mo Splint: 4/16, versus no splint: 5/14 at 2mo
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P=.277
Splint: 0/16, versus no splint: 0/14 at 6mo Splint: 1/16, versus no splint: 1/14 at 2mo Splint: 0/16, versus no splint: 1/14 at 6mo
RI PT
Pillar pain (6mo)
NS, no P value given P=.992
AC C
EP
TE D
M AN U
SC
Abbreviations: NS not significant; RCT, Randomised Controlled Trial; RR relative risk; OR odds ratio; MD mean difference; WMD weighted mean difference; y, years; wk, weeks; d, days; CI, confidence interval; SD, standard deviation; vs, versus, VAS Visual Analogue Scale; kg, kilogram; n, number; mg, milligram’; CTD, carpal tunnel decompression; PEM, Patient Evaluation Measure; NPRS Numeric Pain Rating Scale; BQ Boston Questionnaire. * in favor of. # groups not compared between groups (ie, only compared within groups).
ACCEPTED MANUSCRIPT
Appendix 3. Additional RCTs: CTS Control/comparison
Outcome measures
Results –
Results by Outcome
(total FU time)
Statistical
Measure
Clinical score (>6mo after surgery)
No P value given P<.001
Timing of surgery Chandra et 37 al
Early surgery : <1w after diagnosis (n=51)
Delayed surgery: 6mo after diagnosis (n=49)
Various surgical techniques
Levine Questionnaire Symptom severity scale (60d)
TE D
Release of the transverse carpal ligament without corticosteroid irrigation of the median nerve(n=10)
Functional status scale (60d)
AC C
Release of the transverse carpal ligament with corticosteroid irrigation of the median nerve before skin closure (n=10)
EP
86
Padua et al
P<.001
M AN U
Return to activity, percentage complete return (>6mo after surgery)
RI PT
Treatment
SC
Author
P=.005
Early: mean ± SD, 20.06±2.12, vs delayed: 21.33±1.55 at baseline Early: mean ± SD, 8.11±3.85, vs delayed: 18.19±4.32 at >6mo follow-up after surgery Early: 100%, vs delayed 11% at >6mo follow-up
Steroid treatment group*: from mean ±SD, (95% CI), 44.8±6.0 (41.0-48.6) at baseline to 11.8±1.3 (10.8-12.7) at 60d vs controls: from
NS, no P value given
41.8±5.4 (37.6-45.9) at baseline to 19.4±2.1 (17.8-21.1) at 60d Steroid treatment group: from mean ± SD, 28.8±9.2 (22.334.1) at baseline to 9.00±1.6 (7.9-10.1) at 60d vs controls: from 26.9±9.2 (19.8-34.0) at baseline to 15.4±1.3 (14.4-16.5) at 60d
Abbreviations: NS not significant; RCT, Randomised Controlled Trial; n, number; d, days; wk, weeks; SD, standard deviation; vs, versus; VAS, Visual Analogue Scale. * in favor of. # between groups not compared (i.e. only within groups); CTS, carpal tunnel syndrome.
S0003-9993(17)30372-6
DOI:
10.1016/j.apmr.2017.04.024
Reference:
YAPMR 56901
To appear in:
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION
Received Date: 15 January 2017 Revised Date:
17 April 2017
Accepted Date: 27 April 2017
Please cite this article as: Huisstede BM, van den Brink J, Randsdorp MS, Geelen SJ, Koes BW, The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A Systematic Review, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2017), doi: 10.1016/ j.apmr.2017.04.024. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
Running head: Effectiveness (post)surgical treatments for CTS
2 3
The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A
4
Systematic Review
5 6 7
Bionka MA Huisstede
8
Geelen BSc, Bart W Koes PhD
1
1
2
9 1
University Medical Center Utrecht, Rudolf Magnus Institute of Neurosciences, Department of Rehabilitation, Physical Therapy Science & Sports 2 Erasmus MC, Department of General Practice, Rotterdam, The Netherlands
SC
10 11 12
This material has not been presented elsewhere
15 16
No financial support was provided
17 There are no conflicts of interest
TE D
18
M AN U
13 14
,2
PhD, Janneke van den Brink PT, MSc, Manon S Randsdorp MD, Sven JG
RI PT
1,2
19 20 21
Address for correspondence:
23
Bionka M.A. Huisstede, PhD
24
Rehabilitation, Physical Therapy Science & Sports, Room, Building W01.121
25
University Medical Center Utrecht
26
P.O. Box 85500
27
3508 GA Utrecht, The Netherlands
28
The Netherlands
29
Tel: +31-88-7560945
30
E-mail: [email protected]
AC C
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22
31 32 1
ACCEPTED MANUSCRIPT 1
The Effectiveness of Surgical and Post-Surgical Interventions for Carpal Tunnel Syndrome–A
2
Systematic Review
3 ABSTRACT
5
Objective: To present an evidence-based overview of the effectiveness of surgical and postsurgical
6
interventions for carpal tunnel syndrome (CTS).
7
Data Sources: The Cochrane Library, PubMed, EMBASE, CINAHL and PEDro were searched for
8
relevant systematic reviews and randomized controlled trials (RCTs) up to April 8th 2016.
9
Data Selection and Extraction: Two reviewers independently selected the studies, extracted the
RI PT
4
data, and assessed the methodological quality.
11
Data Synthesis and Results: A best-evidence synthesis was performed to summarize the results.
12
Four systematic reviews and 33 RCTs were included. Surgery versus non-surgical interventions,
13
timing of surgery, various surgical techniques and post-operative interventions were studied.
14
Corticosteroid injection was more effective than surgery (strong evidence, short-term). Surgery was
15
more effective than splinting or anti-inflammatory drugs plus handtherapy (moderate evidence, mid-
16
and longterm). Manual therapy was more effective than surgical treatment (moderate evidence, short
17
and midterm). Within surgery, corticosteroid irrigation of the median nerve before skin closure as
18
additive to CTS-release or the direct vision plus tunnelling technique were more effective than
19
standard open CTS-release (moderate evidence, short term). Furthermore, short- was more effective
20
than long- bulky dressing and a sensory retraining program was more effective than no program after
21
surgery (moderate evidence, shortterm). For all other interventions only conflicting, limited, or no
22
evidence was found.
23
Conclusions: Surgical treatment seems to be more effective than splinting, anti-inflammatory drugs
24
plus hand therapy the in short, mid and/or long term to treat CTS. Although there is strong evidence
25
that a local corticosteroid injection is more effective than surgery in shortterm and moderate evidence
26
that manual therapy is more effective than surgery in short and midterm. There is no unequivocal
27
evidence that suggests one surgical treatment is more effective than the other. Postsurgical, a short-
28
favored a long-duration bulky dressing and a sensory retraining program seems to be more effective
29
than no program in shortterm. More research regarding the optimal timing of surgery for CTS is
30
needed.
AC C
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M AN U
SC
10
1
ACCEPTED MANUSCRIPT 31
Keywords: Carpal tunnel syndrome; Orthopaedic and plastic surgery; Rehabilitation; Review
32
[publication type]; Treatment outcome.
33 34
List of Abbreviations
CANS, complaints of the arm, neck and/or shoulder
37
CI, confidence interval
38
CTS, carpal tunnel syndrome
39
MD, mean difference
40
OR, odds ratio
41
RCT, randomized controlled trial
42
RR, relative risk
43
VAS, visual analog scale
44
WMD, weighted mean differences
45
SMD, standardized mean differences
49 50 51 52 53 54 55 56
M AN U
EP
48
AC C
47
TE D
46
SC
36
RI PT
35
57 58 59 60
2
ACCEPTED MANUSCRIPT 61 62 63
Carpal tunnel syndrome (CTS), the most common entrapment neuropathy, is one of the 6 specific
64
neuropathies mentioned in the complaints of the arm, neck and/or shoulder (CANS) model.
65
report a history of nocturnal pins and needles, numbness and/or pain in the median nerve innervated
66
area of the fingers, consequently often resulting in night waking.
1-3
Patients
RI PT
4
67 5
CTS can be treated conservatively without surgery. Surgery may be indicated when conservative
69
treatment fails. European clinical experts agreed that CTS should be treated with instructions plus
70
splinting, corticosteroid injections, splinting plus corticosteroid injections, or surgery. The Cochrane
71
review of Verdugo et al reported that surgical treatment of carpal tunnel syndrome relieves
72
symptoms significantly better than splinting. The AAOS guideline reported that surgical treatment of
73
carpal tunnel syndrome should have a greater treatment benefit at 6 and 12 months as compared to
74
splinting, NSAIDs/therapy and a single steroid injection. The basic principle of CTS surgery is to
75
increase the volume of the carpal tunnel temporarily by dividing the transverse carpal ligament in order
76
to release the pressure on the median nerve. Two surgical approaches are commonly used: open
77
and endoscopic treatment.
78
complications for endoscopic carpal tunnel release compared to open carpal tunnel release, but
79
reported no difference in the rates of major complications. Over time, several surgical techniques were
80
introduced to increase the success rate of CTS-surgery by reducing postoperative pain, limited
81
function and shortening recovery time, for example by adding tenosynovectomy or transverse carpal
82
ligament reconstruction.
83
evidence supporting the need for replacement of standard open carpal tunnel release by existing
84
alternative surgical procedure. Rehabilitation treatments are believed to speed up recovery and
85
manage pain or symptoms from the surgery itself. However, the Cochrane Review of Peters et al
86
reported limited evidence of the various types of rehabilitation treatment studied (immobilisation,
87
dressing, exercise, cold and ice therapy, different types of hand rehabilitation, laser therapy, electrical
88
treatments, scar desensitisation, and arnica). Since the publication of the Cochrane reviews on this
89
topic, several randomised clinical trials (RCTs) have been published and we were wondering whether
90
the conclusions of the Cochrane reviews would remain the same or needed modification. This review
SC
68
M AN U
7
6
8
9
EP
The Cochrane review of Scholten et al
16
reported that there is no strong
AC C
15
14
The Cochrane review of Vasiliadis et al reported fewer minor
TE D
10-13
17
3
ACCEPTED MANUSCRIPT 91
presents an overview of the effectiveness of surgical and postsurgical treatments for CTS. This
92
concerns an update of our previous systematic review on this topic.
18
93 94 95
METHODS
RI PT
96 Search Strategy
98
A search of relevant systematic reviews on CTS was performed in the Cochrane Library. In addition,
99
relevant review publications and RCTs in PubMed, EMBASE, CINAHL and PEDro were searched (1)
100
for interventions included in the systematic reviews from the date of the search strategy of the review
101
up to April 8th 2016 (ie, recent RCTs) and (2) from the beginning of the database up to April 8th 2016
102
(ie, additional RCTs).
M AN U
SC
97
103 Inclusion Criteria
105
Systematic reviews and/or RCTs were considered eligible for inclusion if they fulfilled all of the
106
following criteria: 1) the study included patients with CTS, (2) CTS was not caused by an acute trauma
107
or any systemic disease (such as osteoarthritis, rheumatoid arthritis, diabetes mellitus, or other
108
connective tissue disease) as described in the definition of Complaints of the Arm, Neck and/or
109
Shoulder (CANS), (3) an intervention for treating the disorder was evaluated and (4) results on pain,
110
function, or recovery were reported. There were no language restrictions.
111
Studies on the effectiveness of analgesics given pre-surgery, during surgery or directly postsurgery
112
and in which the effect of these analgesics on pain as a result of the surgery was studied are excluded
113
from this review. Moreover, studies reporting on the effect of sutures were excluded.
EP
AC C
114
TE D
104
115
Study Selection
116
Two reviewers (B.M.H./T.F. and M.S.R. /S.J.G.G.) independently applied the inclusion criteria to select
117
potential relevant studies from the title and abstracts of the references retrieved by the literature
118
search. A consensus method was used to solve any disagreements concerning inclusion of studies,
119
and a third reviewer (B.K.) was consulted if disagreement persisted.
120 4
ACCEPTED MANUSCRIPT Categorization of the Relevant Literature
122
Relevant articles are categorized under 3 headers: Systematic reviews, Recent RCTs and Additional
123
RCTs. The header "Systematic reviews" describes all Cochrane and Cochrane-based systematic
124
reviews. The header "Recent RCTs" covers all RCTs published from the final date of the search
125
strategy that the systematic review covered. Finally, the header "Additional RCTs" describes all RCTs
126
concerning interventions that have not yet been described in a systematic review
RI PT
121
127 Data extraction
129
Two authors (M.S.R./J.B. and B.M.H./S.J.G.G.) independently extracted the data. A consensus
130
procedure was used to solve any disagreement between the authors.
131
The follow-up time was categorized into short term (0-3mo), midterm (4-6mo) and long term (> 6mo).
132
Methodological quality assessment
133
Two reviewers independently extracted data and assessed the methodological quality (list of Furlan et
134
al , appendix 1).
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128
19
135 Data synthesis
137
If a quantitative analysis of the studies was not possible because of diverse outcome measures and
138
other clinical heterogeneity, a meta-analysis was not performed. A best-evidence syntheses was used
139
to summarize the results (table 1).
140
supplementary file 1.’
AC C
142
144
A detailed description of the method can be found in
EP
20
141
143
TE D
136
RESULTS
145
Characteristics of the Included Studies
146
Initially, we identified 563 systematic reviews (the Cochrane Library: 16, Pubmed: 263, EMBASE: 224,
147
CINHAL: 27, PEDro: 33) and 2681 RCTs (697 from PubMed, 1718 from EMBASE, 156 from CINAHL,
148
110 from PEDro). Finally, 4 Cochrane reviews and 33 RCTs (PubMed: 27, EMBASE: 6, PEDro: 0,
149
CINAHL: 0) were included in our systematic review, figure 1. A detailed description of inclusion and
150
exclusion of the selected reviews is described in supplementary file 2.
21-25
5
ACCEPTED MANUSCRIPT 151
The characteristics of the included studies are reported in appendix 1 (systematic reviews), appendix
152
2 (recent RCTs) and appendix 3 (additional RCTs).
153 Methodological Quality of the Included Studies
155
The results of the methodological quality assessment of the 33 included recent and additional RCTs
156
are presented in table 2. The methodological quality assessments used in the Cochrane reviews of
157
Vasiliadis et al , Scholten et al , Verdugo et al and Peters et al are described in table 3-6
158
respectively.
159
57 (60%) of low-quality.
14
20, 26, 27
16
7
RI PT
154
17
Of the 95 RCTs identified in our systematic review 38 (40%) were of high-quality,
SC
160 Effectiveness of Interventions
162
Evidence for the effectiveness of (post) surgical treatment of CTS can be found in table 7 and 8.
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161
163 164
1. Surgical Versus Nonsurgical Treatment
165
Systematic review. The Cochrane review of Verdugo et al examined surgical versus nonsurgical
166
treatment of which 4 RCTs (n=349) were included. One low-quality RCT
167
compared surgical treatment with splinting (a splint for 1-month and a night splint for at least 6weeks,
168
respectively). At 3- and 6-months follow-up, in the high-quality RCT, significantly better results were
169
reported on clinical improvement in favor of surgery compared with splinting (RR=1.38, 95% CI, 1.08-
170
1.75, and RR=1.29, 95% CI, 1.08-1.55, respectively). At 1-year follow-up, the pooled estimate with
171
regard to clinical improvement showed that surgical treatment of CTS relieves symptoms significantly
172
better than splinting (RR=1.27; 95% CI, 1.05 to 1.53).
173
The other 2 high-quality RCTs , included in the Cochrane review of Verdugo et al compared
174
surgery to steroid injection. Ly-Pen et al found significantly better results in favor of corticosteroid
175
injections versus surgical decompression on improvement in clinical symptoms at 3-months follow-up
176
(RR=.66; 95% CI, .49-.90). At 6- and 12-months follow-up, no significant results were found between
177
the groups on the same outcome measurements. Hui et al
178
favor of surgery on the outcome improvement in clinical symptoms (RR=2.18; 95% CI, 1.39-3.42) at 3-
179
months follow-up. Clinical improvement in grip strength was not significant at 20-weeks follow-up.
TE D
7
28
and 1 high-quality RCT
29
AC C
EP
29
30 31
7
30
31
reported significantly better results in
6
ACCEPTED MANUSCRIPT 25, 32-36
180
Recent RCTs. Six recent RCTs
181
carpal tunnel decompression with nonsurgical therapy. Four of these RCTs
182
injection with open carpal tunnel release: Ly-pen et al
183
high-quality), Andreu et al
184
performed an additional analysis of the before mentioned study included in the review of Verdugo et
185
al with an extended follow-up of 2-years,
186
At 24-months follow-up, Ly-Pen et al reported significant differences on nocturnal paraesthesias
187
(P<.001) and self-perceived functional impairment (P=.008) in favor of surgery versus corticosteroid
188
injections and no significant differences on diurnal pain.
189
At 12-weeks follow-up Ismatullah et al found significant differences in favor of open carpal tunnel
190
release versus local steroid injection (P=.000) on the Global Symptom score.
191
Andreu et al
192
(P=.008 and P=.018) and nocturnal paraesthesias (P=.041 and P=.002) at 3- and 12-months follow-
193
up, but not at 6-months.
194
Ucan et al
195
should be worn 24 hours a day for 3-months. The second group also received the splint but was first
196
injected with a local steroid. The third group was treated surgical with an open carpal tunnel release.
197
At 3-months of follow-up, no significant changes were found. At 6-months of follow-up, significant
198
results on the symptom severity score were found in favor of the third group (P=.004) and on the
199
function capacity scale (P=.03).
200
Jarvik et al , (n=116, high-quality) compared surgical treatment including open or endoscopic carpal
201
tunnel decompression with a combination of interventions including: Ibuprofen, hand therapy for 6
202
weeks in 6 sessions and ultrasound therapy at 6-weeks follow-up if there was no improvement after
203
hand therapy. Significant differences between the groups were found in favor of surgery on the Carpal
204
Tunnel Syndrome Assessment Questionnaire on function (MD=.46; 95% CI, .20-.72) and symptoms
205
(MD=.42; 95% CI, .07-.77) at 6-months follow-up. Significant results were also found at 12-months
206
follow-up (function: MD=.40, 95% CI, .11-.70; symptoms: MD=.34, 95% CI, .02-.65). No significant
207
differences were found on pain intensity at 6-months and 1-year follow-up.
208
Penas et al (n=120, high-quality) compared manual therapy with carpal tunnel release (open and
209
endoscopic). Significant differences were found on mean hand pain, worst hand pain, and the
compared surgical treatment including open or endoscopic
34
35
34-36
compared local steroid 36
(n=163, high-quality), Ismatullah et al
(n=40,
25
34
(n=163, low-quality) and Ucan et al (n=57, low-quality). Ly-pen et al 30
34
M AN U
reported significant differences for functional impairment (P=.003 and P=.014), pain
compared three interventions groups. The first group was treated with a neutral splint that
AC C
33
EP
TE D
25
35
SC
36
RI PT
7
32
7
ACCEPTED MANUSCRIPT functional status scale, in favor of the manual therapy group (no P-values given) at 3-months follow-
211
up. No significant difference was found on the symptom severity scale at 3-months follow-up. The
212
significant difference in favor of manual therapy on worst hand pain remained at 6-months (no P-value
213
given). No significant differences between groups were found at 12-months follow-up.
214
In conclusion, there is moderate evidence that surgical treatment is more effective than splinting in the
215
midterm and long term, and there is conflicting evidence in the short term. We found strong evidence
216
for the effectiveness of steroid injections compared with surgery in the short term, no evidence in the
217
midterm and limited evidence in favor of surgery in the long term. Furthermore, there is moderate
218
evidence that surgical treatment is more effective than nonsurgical therapy using non-steroidal anti-
219
inflammatory drugs plus hand therapy (plus ultrasound in cases not responding to hand therapy) in the
220
midterm and long term. In contrast, moderate evidence was found in favor of manual therapy in
221
comparison with surgical treatment in the short term and midterm. In the long term, there is no
222
evidence for the effectiveness in favor of one of these treatment options.
223
2. Timing of surgery
224
Additional RCTs. One low-quality RCT
225
delayed (>6-months after diagnosis) endoscopic carpal tunnel release in patients with moderately
226
severe CTS. Chandra et al
227
measures: general improvement, nocturnal awakening, severity of most important symptoms, patient
228
satisfaction, use of pain medication, the symptom severity scale and the functional status scale which
229
was used to make comparisons between groups. After at least 6-months follow up, a significant
230
difference was found on the clinical score in favor of the early surgery group (P<.001).
231
There is limited evidence for the effectiveness of early surgery (<1 week after diagnosis), compared
232
with delayed (>6-months after diagnosis) surgery in the midterm and long term.
SC
M AN U
TE D
(n=100) compared early (<1 week after diagnosis) with
used a clinical score, which was a combination of different outcome
EP
37
37
AC C
233
RI PT
210
234
3. Various Surgical Techniques
235
Two Cochrane reviews
236
surgical techniques. The Cochrane review by Vasiliadis et al
237
endoscopic carpal tunnel release with any other type of surgical intervention for CTS (n=2586). The
238
Cochrane review by Scholten reported on studies comparing various surgical techniques for CTS.
14, 16
, 25 recent RCTs and 1 additional RCT were found that dealt with various 14
reported on studies comparing
16
8
ACCEPTED MANUSCRIPT 239
Eight studies comparing open carpal tunnel release with any other surgical intervention were included
240
in our review (n=553).
241 242
Endoscopic Versus Standard Open Carpal Tunnel Release
243
Systematic review. Two high-quality studies
244
included in the Cochrane review of Vasiliadis et al
245
carpal tunnel release. Ten studies
246
Significant results were found on pain scores in favor of endoscopic carpal tunnel release versus
247
standard open carpal tunnel release (two studies
248
for grip strength (five studies
249
carpal tunnel release. No significant differences were found on overall improvement, the symptom
250
severity scale, the functional status scale, pain, numbness and recurrence of symptoms. In the mid
251
and long term (>3-months) a significant difference was found on grip strength in favor of endoscopic
252
versus standard open carpal tunnel release (two studies
253
.56 to 1.71), but no significant differences were found on overall improvement, the symptom severity
254
scale, the functional status scale, pain, numbness and recurrence of symptoms.
255
Recent RCTs. In total three high-quality
256
The high-quality study of Atroshi et al
257
years) of the study of Atroshi et al
258
Vasiliadis et al . No significant differences were found between two-portal endoscopic and open
259
carpal tunnel release on the symptom severity scale and the function severity scale at 12.8-year
260
follow-up. Gumustas et al
261
endoscopic and open carpal tunnel release on the functional status scale and the symptom severity
262
scale at 6-months follow-up.
263
Ejiri et al
264
pinch strength (P=.01) in favor of one-portal-endoscopic versus open carpal tunnel release at 4-weeks
265
follow-up. This difference did not sustain at 12-weeks follow-up. Sensibility tests were not significant at
266
4- and 12-weeks follow-up.
267
Michelotti et al , (n=50, low-quality) and Aslani et al
and 21 low-quality RCTs
14
(total n=2209)
reported on endoscopic versus standard open
38, 40-42, 46, 50, 52, 54, 55, 61
short term, SMD= -.41; 95% CI, -.65 to -.18) and
SC
38, 50
reported results in the short term (≤3-months).
short term, SMD=.40; 95%CI, .10 to .71) in favor of endoscopic
M AN U
38, 40-42, 50
10, 38-60
RI PT
38, 39
62
38
22, 64, 65
were found.
(n=128) concerned a long term follow-up (mean±SD, 12.8±1.2
which was previously included in the Cochrane review of
EP
14
mid and long term, SMD= 1.13; 95% CI,
and three low-quality recent RCTs
TE D
23, 62, 63
40, 42
(n=41, high-quality) found no significant differences between two-portal-
AC C
63
23
(n=101, high-quality) reported significant differences on grip strength (P=.04) and side
64
22
(n=96, low-quality) reported no significant
9
ACCEPTED MANUSCRIPT 268
differences between two-and-one-portal-endoscopic and open carpal tunnel release for outcomes on
269
pain, function and recovery in respectively 4-weeks/4-months and 12-weeks/24-weeks follow-up.
270
Zhang et al (n=213, low-quality) compared subneural reconstruction of the transverse carpal
271
ligament (group 1) with open carpal tunnel release (group 2) and two-portal-endoscopic carpal tunnel
272
release (group 3). On the functional status scale and pinch grip, significant differences were found
273
between group 2 and 3 (P=.045, P=.007) in favor of group 3 at 3-months follow-up, but not at 6-,12-
274
and 24-months follow-up. The Michigan Hand Outcome showed significant differences between group
275
2 and 3 in favor of group 3 at 12- and 24-months follow-up (P=.006, P=.001). No significant
276
differences between group 2 and 3 were found on the symptom severity scale, cylindrical grip strength
277
and lateral grip strength at 3-,6-,12- and 24-months follow-up.
278
Thus, we found conflicting evidence for the effectiveness of endoscopic compared with standard open
279
carpal tunnel release in the short, mid and, long term.
280
Endoscopic Versus Miniopen Carpal Tunnel Release
281
Systematic review. In total 5 low-quality studies
282
review of Vasiliadis et al , reported on endoscopic versus miniopen carpal tunnel release, of these
283
three RCTs
284
the short term (≤3-months). A significant difference was found on the pain assessed on non-
285
continuous dichotomous scales in favor of endoscopic carpal tunnel release compared with standard
286
open carpal tunnel release (one study short term, RR= 2.00; 95% CI, 1.01 to -3.95). No significant
287
differences were found on overall improvement, the symptom severity scale, the functional status
288
scale, pain, grip strength, and recurrence of symptoms in the short term, midterm and long term.
289
Recent RCTs. The high-quality RCT of Kang et al
290
between one-portal-endoscopic and miniopen carpal tunnel release on the symptom severity scale
291
(P=.774), the functional status scale (P=.832) and the Disabilities of the Arm, Shoulder and Hand
292
(P=.978) at 3-months follow-up.
293
Larsen et al , (n=90, low-quality) reported a significant difference in favor of one-portal-endoscopic
294
versus miniopen carpal tunnel release on range of motion at 3-weeks follow-up, but not at 6-, 12- and
295
24-weeks follow-up. At 3- and 6-weeks follow-up, a significant difference in favor of one-portal-
M AN U 49, 59, 66-68
TE D
14
49, 66, 67
SC
RI PT
65
(total n=377), included in the Cochrane
reported results on pain, function or recovery. Two studies
49, 67
reported results for
AC C
EP
67
24
(n=104) showed no significant difference
69
10
ACCEPTED MANUSCRIPT 296
endoscopic release was found on grip strength (no P value given), but not at 12- and 24-weeks follow-
297
up.
298
We found conflicting evidence that endoscopic carpal tunnel release is more effective in comparison
299
with miniopen carpal tunnel release in the short term and no evidence in favor of one of these
300
treatments in the mid and long term.
RI PT
301 302
Endoscopic One or Two Portal Versus Open or Miniopen Carpal Tunnel Release
303
Systematic review. In total, 1 high-quality study and 15 low-quality studies
304
reported on one-portal endoscopic versus open or miniopen carpal tunnel release and 1 high-quality
305
study and 8 low-quality studies
306
miniopen carpal tunnel release, all included in the Cochrane review of Vasiliadis et al , Eight
307
studies
308
assessed on a non-continuous dichotomous scales favored one-portal carpal tunnel release over
309
standard open carpal tunnel release (two studies
310
grip strength in favor of two-portal carpal tunnel release versus standard open carpal tunnel release
311
(three studies
312
difference on grip strength (>3-months) was found in favor of one-portal versus standard open carpal
313
tunnel release (one study mid-term and long term, SMD= 1.28; 95% CI, .60 to 1.96).
314
Recent RCTs. The same RCTs mentioned in “Endoscopic Carpal Tunnel Release Versus Standard
315
Open Carpal Tunnel Release” and “Endoscopic Carpal Tunnel Release Versus Miniopen Carpal
316
Tunnel Release” are included.
317
RCTs
318
open or miniopen carpal tunnel release (one-portal: two high-quality RCTs
319
RCTs
320
In conclusion, we found conflicting evidence for the effectiveness of one-portal endoscopic compared
321
with open carpal tunnel release in the short and midterm and no evidence in the long term. Further, we
322
found conflicting evidence for the effectiveness of two-portal endoscopic versus open carpal tunnel
323
release in the short, mid-, and, long term. No studies reported on one versus two-portal carpal tunnel
324
release.
38
reported short term (≤3-months) results. Significant results were found on pain
EP
22-24, 62-65, 69
and 4 low-quality RCTs
AC C
64, 69
52, 61
short term, OR=.06; 95% CI, .02 to .22) and for
short term, SMD=.27; 95% CI, .02 to .53). In the mid- and long term a significant
40
23, 24, 62, 63
14
TE D
38, 41, 42
reported on two-portal-endoscopic versus open or
M AN U
38, 40, 42, 44, 52-54, 61
41-43, 47-49, 67, 68
10, 40, 44-46, 50, 51, 53-55, 59-61, 66
SC
39
For the outcomes see above. In total 4 recent high-quality
22, 64, 65, 69
, two-portal: two high-quality RCTs
compared one or two-portal carpal tunnel release with
62, 63
23, 24
and two low-quality
22, 69
and two low-quality RCTs).
325
11
ACCEPTED MANUSCRIPT 326
Miniopen Technique Assisted by Knifelight Instrument Versus Standard (mini) Open Carpal
327
Tunnel Release
328
Systematic review. Two high-quality studies
329
review of Scholten et al , compared the miniopen technique assisted by the Knifelight instrument
330
versus standard open release or open release with mini-incision (≤3-months: OR=.76; 95% CI, .14-
331
4.28). Of these, only 1 low-quality study found a significant result in favor of the Knifelight instrument
332
on the symptom severity score after a mean follow-up of 19-months (range, 12-28months). However,
333
these results were not maintained at a mean follow-up of 30- (range, 24-42) or 60 -months.
334
Recent RCTs: Two low-quality studies
335
the Knifelight instrument versus standard open release. Elsharif et al (n=82) was a long term follow-
336
up of the study of Helm et al
337
al . A significant difference was found in favor of the Knifelight in the Quick-DASH (P=.0024) at 10-
338
years follow-up.
339
The low-quality study of Heidarian et al (n=59) did not find significant differences between groups on
340
pain at 3-weeks follow-up.
341
There is limited evidence that the miniopen technique assisted by the Knifelight instrument is more
342
effective than a standard open release in the long term, however, there is no evidence in the short and
343
midterm.
70, 71
72
and 1 low-quality study , included in the Cochrane
16
RI PT
72
73
74, 75
investigated the effect of the open technique assisted by
which was previously included in the Cochrane review of Scholten et
16
TE D
75
M AN U
71
SC
74
344
Modified Open Versus Standard Open Carpal Tunnel Release
346
Systematic review. Four high-quality
347
of Scholten et al reported on open tunnel release with a modified versus standard incision (4 RCTs
348
76, 78, 79, 81
349
and recovery between groups were found on short, mid- and, long term.
350
Recent RCTs. Three low-quality recent RCTs
351
al (n=120) compared minimal access carpal tunnel release with standard open carpal tunnel release
352
and found significant differences on the symptom severity scale and the functional status scale in
353
favor of the minimal access group at 6-months and 12-months follow-up (P<.001).
354
One RCT (n=90) reported significant difference on grip strength in favor of open carpal tunnel release
355
versus open carpal tunnel release short incision at 12-weeks follow-up (no P value given), but not at
EP
345
76-79
82
AC C
16
short term, 2 RCTs
68, 77
and 2 low-quality RCTs
68, 80
included in the Cochrane review
midterm and long term). No significant differences on pain, function,
22, 69, 82
were found. The low-quality study of Tarallo et
12
ACCEPTED MANUSCRIPT 356
24-weeks. No significant differences between groups were found on pain, pareasthesis and range of
357
motion.
358
Aslani et al , (n=96, low-quality) studied endoscopic carpal tunnel release (group 1) with regular open
359
carpal tunnel release (group 2) and mid-palmar mini incision (group 3). Significant differences between
360
groups were found on pain at 4 weeks (P<.05), for grip strength (P<.05) and weakness (P<.05) at 4-
361
months follow-up, all in favor of group 3 versus group 2. No significant differences were found on night
362
pain, numbness, stiffness, wrist pain and pain at 4-months follow-up.
363
There is conflicting evidence for the effectiveness of modified carpal tunnel release, compared with
364
standard open tunnel release in the short, mid- and, long term.
SC
365
RI PT
22
366
Carpal Tunnel Decompression With Preserving Technique Versus Standard Technique
367
Recent RCTs. The high-quality RCT
368
decompression by using a technique in order to preserve the superficial nerve branches compared
369
with a standard technique on scar pain scores or the second part of the Patient Evaluation Measure
370
score at 3- and 6-months follow-up.
371
Forward et al
372
parietal layer of the ulnar bursa to division of the ulnar bursa. No significant differences were found on
373
grip strength and the Patient Evaluation Measure score at 9-weeks follow-up.
374
No evidence was found in favor of nerve-preserving decompression versus standard decompression
375
of the carpal tunnel in the short and midterm. Furthermore, we found no evidence for open carpal
376
tunnel release with preservation of the parietal layer of the ulnar bursa compared to division of the
377
ulnar bursa in the short term.
M AN U
(n=84) found no significant differences in favor of carpal tunnel
EP
TE D
(n=111, low-quality) compared open carpal tunnel release with preservation of the
AC C
378
84
83
379
Steroids as Additive to Open Carpal Tunnel Release
380
Recent RCTs. Stepic et al
381
betamethasone as additive to open carpal tunnel release on symptom reduction at 7- and 90-days
382
follow-up, but no comparisons between groups were made.
383
Additional RCTs. Padua et al
384
nerve before skin closure as additive to release of the transverse carpal ligament. Significant
385
differences were found on the symptom severity score in favor of those treated with corticosteroid
85
(n=40, low-quality) examined a perineural injection of 1mL
86
(n=20, high-quality) studied corticosteroid irrigation of the median
13
ACCEPTED MANUSCRIPT irrigation versus the release-only group (P=.005) and no significant differences on the function severity
387
score in the short term.
388
There is no evidence for the effectiveness of a perineural steroid injection with 1mL betamethasone as
389
additive to open carpal tunnel release. Furthermore, there is moderate evidence that corticosteroid
390
irrigation of the median nerve before skin closure as additive to surgical release of the carpal ligament
391
is effective in the short term.
RI PT
386
392 393
Other Surgical Techniques
394
Systematic review. The Cochrane review of Scholten et al compared surgery with or without
395
regarding lengthening of the flexor retinaculum (1 high-quality study on short and midterm results),
396
surgery with or without internal neurolysis (1 high-quality study reporting on short term and 1 high-
397
quality study reporting on long term results; overall improvement ≤ 3-months, RR=1.02; 95% CI, .68-
398
1.54, and >3-months, RR=.92; 95% CI, .74-1.14). Moreover, surgery with or without epineurotomy
399
(overall improvement after 3-months, RR=.93, 95% CI, .58-1.50; 1 high-quality study , long term) and
400
surgery with or without tenosynovectomy (1 low-quality study,
401
in favor of one of the interventions studied was found.
402
Recent RCTs. In total three high-quality RCTs
403
One high-quality RCT of Crnkovic et al
404
longitudinal epineurotomy versus standard open carpal tunnel release. In contradiction to the study of
405
Leinberry et al , a significant difference on pain (10-point scale) was found in favor of the standard
406
carpal tunnel release at 180-days follow-up (MD=1.38; 95% CI, .26 to 2.49, P=.017).
407
Suppaphol et al
408
vision plus tunneling technique with standard open carpal tunnel release. Only in grip strength a
409
significant difference in favor of the limited open carpal tunnel release was found at 3-months follow-
410
up (P=.004).
411
Cho et al (n=84, high-quality) studied short wrist transverse open technique versus carpal tunnel
412
release with limited open technique. No significant differences were found on symptoms, function or
413
scar discomfort after 1- and 2-years.
16
SC
87
88
M AN U
89
65, 95-101
TE D
and eight low-quality RCTs
were found.
(n=50) studied open carpal tunnel release followed by
(n=30, high-quality) compared the limited open carpal tunnel release using direct
AC C
92
long term). No significant differences
EP
94
90
92-94
91
90
93
14
ACCEPTED MANUSCRIPT 96
414
Acar et al (n=159, low-quality) compared transverse carpal ligament releasing with and without distal
415
forearm fascia releasing. No significant differences between groups were found on pain or night-time
416
paraesthesia at 24-months follow-up.
417
In total three low-quality RCTs of Hamed et al (n=40), Castillo et al (n=30) and Vanni et al
418
(n=220) compared two incision - with standard open carpal tunnel release.
419
Hamed et al
420
6-months follow-up (P=0.04, P=0.03). No benefit was found on grip strength at 3- and 6-months
421
follow-up.
422
Castillo et al
423
score at 6 weeks (P=.03) and third finger score at 6-months (P=.04), both in favor of the standard
424
open carpal tunnel release. No significant differences were found on the functional status scale, the
425
Disabilities of the Arm, Shoulder and Hand Questionnaire, scar tenderness, radial pillar pain, ulnar
426
pillar pain, grip strength, pinch strength and the Semmes-Weinstein Monofilament score thumb at 3-
427
and 6-months.
428
Vanni et al compared the double tunnels technique to the standard open technique and found a
429
significant difference in favor of the double tunnels technique on pain (P<.05) and the Boston
430
Questionnaire (P<.05) at 12-months, but not at 3- or 6-months follow-up.
431
Cresswell et al (n=200, low-quality) studied carpal tunnel decompression using the Biomet TM
432
Indiana Tome (miniopen technique) versus standard limited palmar open incision and found significant
433
effects on the Levine-Katz questionnaire on symptoms at 7-years follow-up (P<.05). No significant
434
differences were found on the Levine-Katz questionnaire on symptoms 3-months after surgery; the
435
Levine-Katz questionnaire on function 3-months and 7-years after surgery; and pain, grip strength,
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and pinch grip 3-months after surgery.
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Zhang et al (n=213, low-quality) compared subneural reconstruction of the transverse carpal
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ligament (group 1) with open carpal tunnel release (group 2) and endoscopic carpal tunnel release
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(group 3). On the functional status scale (at 3-,6,12 and 24-months), cylindrical grip strength (3-,6-, 12-
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and 24-months), pinch grip strength (at 6-,12- and 24-months) and the Michigan Hand Outcome (at
441
12- and 24-months) significant differences were found at 3-,6-,12-, and 24-months follow-up between
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group 1 and 2 and between group 1 and 3, both in favor of group 1 (P<.032). No significant differences
98
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found significant differences on pain in favor of the double incision technique at 3- and
found significant differences on the Semmes-Weinstein Monofilament, second finger
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between group 1 and 2 were found on the symptom severity scale, cylindrical grip strength and lateral
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grip strength at 3-,6-,12- and 24-months follow-up.
445
Uçar et al
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to flexor crease. No significant differences were found on the Boston Carpal Tunnel Questionnaire at
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1-month follow-up.
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Xu et al
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versus standard open approach surgery. Significant differences were found in favor of coronal Z-type
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lengthening of the transverse carpal ligament in grip strength at 6-months (P=.01) and 12-months
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(P=.01), but not at 3-months follow-up.
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In conclusion, there is no evidence with regard to open carpal tunnel release with versus without
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lengthening of the flexor retinaculum in the short and midterm, internal neurolysis in the short term,
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tenosynovectomy in the long term. There is moderate evidence for the effectiveness of direct vision
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plus tunnelling technique compared with open carpal tunnel release in the short term. There is no
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evidence in regard to short wrist transverse open technique versus carpal tunnel release with limited
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open technique in the long term, transverse carpal ligament releasing with distal forearm fascia
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releasing compared to without in the long term, carpal tunnel release with the incision distal compared
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with proximal to the flexor crease in the long term, or miniopen technique using the Biomet TM Indiana
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Tome compared with standard open incision in the short term.
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There is limited evidence for the miniopen technique using the Biomet TM Indiana Tome compared
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with standard open incision at 7-years of follow-up and for the subneural reconstruction of the
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transverse carpal ligament compared with endoscopic carpal tunnel release in the short, mid- and,
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long term. There is also limited evidence in favor of coronal Z-type lengthening of the transverse
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carpal ligament compared with standard open approach surgery in the midterm and long term, but no
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evidence in the short term. Further, there is conflicting evidence for the double compared with
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standard single incision technique in the short and midterm and limited evidence in the long term.
468
Further, we found conflicting evidence for the effectiveness of epineurotomy on the median nerve
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volume in the long term.
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(n=58, low-quality) compared coronal Z-type lengthening of the transverse carpal ligament
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(n=90, low-quality) compared carpal tunnel release with the incision distal versus proximal
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4. Postoperative Treatments
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Systematic review. The Cochrane review of Peters et al
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rehabilitation interventions following CTS surgery versus no treatment, placebo, or another
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intervention; 13 high-quality RCTs
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One high-quality study
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strip (2-3 days) with long duration bulky dressing (9-14 days) after surgery. Significant differences in
477
favor of short duration bulky dressing were found on grip strength (MD=-16.0 (95% CI, -21.57 to -
478
10.43)) and tip pinch strength (MD=-1.20 (95% CI, -2.35 to -.05)) at 6- to 12-weeks follow-up. No
479
significant differences were found on the 3-point pinch - and lateral pinch strength at 6- to 12-weeks
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follow-up. In one high-quality study
481
group after surgery to treat CTS. At 8-weeks follow-up, significant differences in favor of the retraining
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program were found on the Shape-Texture Identification Test (MD=1.94 (95% CI, .68 to 3.20)) and the
483
Locognosia test (MD=6.31 (95% CI, 1.14 to 11.48)). No significant differences were found on the
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Weinstein Enhanced Sensory Test, the 2-points discrimination and the Disabilities of the Arm,
485
Shoulder and Hand at 8-weeks follow-up. One high-quality study
486
plus exercises (group 1), laser therapy plus exercises (group 2) and exercises alone (group 3). For
487
pinch grip group 3 was more effective compared with group 1 and 2, in which group 2 was more
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effective than group 1 at 6-weeks follow-up. For pain, group 1 was more effective compared with
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group 2 and 3, in which group 2 was more effective compared with group 3 at 6-weeks follow-up. The
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other studies
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(versus placebo), splint versus bulky dressing, specialized home elevation device versus standard
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sling, controlled cold therapy versus ice therapy, bulky dressing plus splint versus light dressing,
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contrast bath plus exercise versus contrast bath versus exercises, Arnica versus placebo, high-dose
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versus low-dose Arnica and multi-modal hand therapy versus normal activities/exercise, however no
495
significant differences between groups were found for outcomes on pain, function and recovery in the
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short, mid- and/or long term.
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Recent RCTs. Shalimar et al
498
limited open carpal tunnel release. No significant differences between groups were found on pain
499
(VAS), 2-point discrimination test radial and ulnar side of the index finger, pinch and grip strength,
17
and 9 low-quality RCTs
115-123
(total n=1521) were included.
compared short duration bulky dressing with replacement of an adhesive
, a sensory retraining program was compared with a control
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102-114
examined the effectiveness of
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included in the review of Peters et al
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compared: low-level laser
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compared continues ultrasound
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, (n=30, high-quality) compared splint with soft bulky dressing after
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ACCEPTED MANUSCRIPT power grade abductor pollicis brevis, the Boston Questionnaire Symptom Severity Scale, functional
501
status scale and scar and pillar pain at 6-months follow-up.
502
We found moderate evidence in favor of short duration dressing compared with long duration dressing
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after carpal tunnel release and for the effectiveness of a postoperative sensory retraining program
504
compared with control in the short term. We found conflicting evidence for the effect of ultrasound plus
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exercise versus laser therapy plus exercises and exercises alone after carpal tunnel release in the
506
short term. For the other post-operative interventions, no evidence was found in the short, mid- and,
507
long term.
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509 DISCUSSION
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This systematic review provides an overview of the effect of surgical and postsurgical interventions for
512
CTS. The RCTs concentrated on surgical versus non-surgical interventions, timing of surgery, various
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surgical techniques and post-operative interventions. Strong and moderate evidence was found within
514
all these domains, except for timing of surgery. For the latter only one low quality study
515
with limited evidence that early surgery (<1 week after diagnosis) was more effective than delayed
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surgery (>6 months after diagnosis).
517
Taking our results into consideration, surgical treatment seems to be more effective compared with
518
prolonged conservative treatment in the short, mid-, and, long term, although we found strong
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evidence that a local corticosteroid injection is more effective than surgery in short term and moderate
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evidence in favor of manual therapy compared with surgery in the short and midterm. This is in
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agreement with the Cochrane review of Verdugo et al and the AAOS guideline. In the literature,
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conservative treatment is preferred to treat mild to moderate cases of CTS and surgical treatment to
523
treat severe cases.
524
preoperative symptom severity.
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RCTs exploring the optimal timing for surgery are scarce. We only found one RCT
526
early (<1 week after diagnosis) with delayed (>6 months after diagnosis) endoscopic carpal tunnel
527
release in patients with moderately severe CTS, in which limited evidence was found in favor of early
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surgery in the midterm and long term. It might be possible that timing is an important factor for total
529
recovery after surgery. For example, a long-lasting compression can result in axonal damage, which
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6, 125
Future research should focus on stratifying treatment outcomes based on
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that compared
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will not improve after surgery. More high-quality RCTs exploring the optimal timing of surgery are
531
required.
532
Although we found a large number of RCTs examining various surgical techniques of carpal tunnel
533
decompression, no unequivocal conclusion can be made which surgical treatment is superior to the
534
other in treating CTS. This is in agreement with the Cochrane review of Vasiliadis et al
535
reported no differences in the rates of major complications after endoscopic compared to open carpal
536
tunnel release. The Cochrane review of Scholten et al
537
standard open carpal tunnel release by existing alternative surgical procedure. Unless the theoretical
538
framework for the use of smaller or portal incision/preservation of superficial nerve branches/proximal
539
or distal incisions, it seems that the patients outcome is more based on the expertise procedure of the
540
surgeon compared to a specific technique.
541
Furthermore, we found one review (n=22 RCTs) concentrating on post-surgery treatments. Only two
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RCTs found moderate evidence for effectiveness in the short term, a sensory retraining program
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versus no program and short (2-3 days) versus a long (9-14 days) duration bulking dressing is of value
544
for better results in recovery after CTS surgery. More RCTs are needed to provide additional evidence
545
for this statement.
546
Other post-surgical interventions that are advised after CTS surgery by European experts are
547
instructions to the patient, splinting and exercise therapy. It would be interesting to continue studying
548
these post-surgical treatments in more detail in future research.
reported no evidence for replacing the
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which
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Study Limitations
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Some methodological weaknesses of this review need to be addressed. First, we refrained from
552
statistic pooling of the data of the included studies, because of the heterogeneity of these studies. The
553
use of a best-evidence synthesis is a next-best solution and is considered to be a proven method that
554
is commonly used in the field of musculoskeletal disorders.
555
Second, 40% of the included RCTs had a methodological quality score of high-quality. More high-
556
quality RCTs are needed in order to support evidence-based practice.
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Third, we included RCTs if an intervention for treating the disorder was evaluated and results on pain,
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function, or recovery were reported, irrespectively of outcome measurement. Different scales are used
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for outcome evaluation.
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Surgical treatment seems to be more effective than splinting or anti-inflammatory drugs plus hand
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therapy in the short, mid- and/or long term to treat CTS. Although there is strong evidence that a local
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corticosteroid injection is more effective than surgery in shortterm and moderate evidence that manual
566
therapy is more effective versus surgery in the short and midterm. We found no unequivocal evidence
567
that suggests one surgical treatment is more effective than the other, although we found moderate
568
evidence in favor of the direct vision plus tunnelling technique and corticosteroid irrigation of the
569
median nerve before skin closure as additive to carpal tunnel release compared with open carpal
570
tunnel release in the short term. For postsurgical treatments no unequivocal evidence for efficacy was
571
found, although we found moderate evidence that for the short term a short-duration dressing is
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preferable over a long duration dressing and a sensory retraining program seems is more effective
573
than no program after CTS surgery. More research is definitely needed to study the optimal timing of
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surgery in CTS.
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74. Elsharif M, Papanna M, Helm R. Long-term follow up outcome results of Knifelight carpal tunnel release and conventional open release following a departmental randomized controlled trial. A prospective study. Pol Orthop Traumatol 2014;79:67-70. 75. Heidarian A, Abbasi H, Hasanzadeh Hoseinabadi M, Hajialibeyg A, Kalantar Motamedi SM, Seifirad S. Comparison of Knifelight Surgery versus Conventional Open Surgery in the Treatment of Carpal Tunnel Syndrome. Iran Red Crescent Med J 2013;15(5):385-8. 76. Brüser P, Richter M, Larkin G, Lefering R. The operative treatment of carpal tunnel syndrome and its relevance to endoscopic release. European Journal of Plastic Surgery 1999;22(2-3):80-4. 77. Citron ND, Bendall SP. Local symptoms after open carpal tunnel release. A randomized prospective trial of two incisions. J Hand Surg Br 1997;22(3):317-21. 78. Jugovac I, Burgic N, Micovic V, Radolovic-Prenc L, Uravic M, Golubovic V et al. Carpal tunnel release by limited palmar incision vs traditional open technique: randomized controlled trial. Croat Med J 2002;43(1):33-6. 79. Nakamichi K, Tachibana S. Ultrasonographically assisted carpal tunnel release. J Hand Surg Am 1997;22(5):853-62. 80. Nitzsche T, Steen M. Open and modified open surgery technique to split the retinaculum flexorum in treatment of carpal tunnel syndrome. Deutsche Gesellschaft Fur Chirurgie 1999;Suppl Kongressband II:999-1001. 81. Richter VM, Bruser P. [Surgical treatment of carpal tunnel syndrome: a comparison between long and short incision and endoscopic release]. Handchir Mikrochir Plast Chir 1996;28(3):160-6. 82. Tarallo M, Fino P, Sorvillo V, Parisi P, Scuderi N. Comparative analysis between minimal access versus traditional accesses in carpal tunnel syndrome: a perspective randomised study. J Plast Reconstr Aesthet Surg 2014;67(2):237-43. 83. Siegmeth AW, Hopkinson-Woolley JA. Standard open decompression in carpal tunnel syndrome compared with a modified open technique preserving the superficial skin nerves: a prospective randomized study. J Hand Surg [Am] 2006;31(9):1483-9. 84. Forward DP, Singh AK, Lawrence TM, Sithole JS, Davis TR, Oni JA. Preservation of the ulnar bursa within the carpal tunnel: does it improve the outcome of carpal tunnel surgery? A randomized, controlled trial. J Bone Joint Surg Am 2006;88(11):2432-8. 85. Stepic N, Novakovic M, Martic V, Peric D. Effects of perineural steroid injections on median nerve conduction during the carpal tunnel release. Vojnosanit Pregl 2008;65(11):8259. 86. Padua R, Padua L, Bondi R, Campi A, Ceccarelli E, Padua S. Intrasurgical use of steroids on carpal tunnel syndrome: A randomized, prospective, double-blind controlled study. Journal of Orthopaedics and Traumatology. 2003. p 76-80. 87. Dias JJ, Bhowal B, Wildin CJ, Thompson JR. Carpal tunnel decompression. Is lengthening of the flexor retinaculum better than simple division? J Hand Surg Br 2004;29(3):271-6. 88. Lowry WE, Jr., Follender AB. Interfascicular neurolysis in the severe carpal tunnel syndrome. A prospective, randomized, double-blind, controlled study. Clin Orthop Relat Res 1988;227:251-4. 89. Mackinnon SE, McCabe S, Murray JF, Szalai JP, Kelly L, Novak C et al. Internal neurolysis fails to improve the results of primary carpal tunnel decompression. J Hand Surg Am 1991;16(2):211-8. 90. Leinberry CF, Hammond NL, 3rd, Siegfried JW. The role of epineurotomy in the operative treatment of carpal tunnel syndrome. J Bone Joint Surg Am 1997;79(4):555-7.
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91. Shum C, Parisien M, Strauch RJ, Rosenwasser MP. The role of flexor tenosynovectomy in the operative treatment of carpal tunnel syndrome. J Bone Joint Surg Am 2002;84-A(2):221-5. 92. Suppaphol S, Worathanarat P, Kawinwongkovit V, Pittayawutwinit P. The comparison between limited open carpal tunnel release using direct vision and tunneling technique and standard open carpal tunnel release: a randomized controlled trial study. J Med Assoc Thai 2012;95(4):532-6. 93. Cho YJ, Lee JH, Shin DJ, Park KH. Comparison of short wrist transverse open and limited open techniques for carpal tunnel release: a randomized controlled trial of two incisions. J Hand Surg Eur Vol 2016;41(2):143-7. 94. Crnkovic T, Bilic R, Trkulja V, Cesarik M, Gotovac N, Kolundzic R. The effect of epineurotomy on the median nerve volume after the carpal tunnel release: a prospective randomised double-blind controlled trial. Int Orthop 2012;36(9):1885-92. 95. Castillo TN, Yao J. Prospective randomized comparison of single-incision and twoincision carpal tunnel release outcomes. Hand (N Y) 2014;9(1):36-42. 96. Acar MA, Kutahya H, Gulec A, Elmadag M, Karalezli N, Ogun TC. Triggering of the Digits After Carpal Tunnel Surgery. Ann Plast Surg 2015;75(4):393-7. 97. Cresswell TR, Heras-Palou C, Bradley MJ, Chamberlain ST, Hartley RH, Dias JJ et al. Long-term outcome after carpal tunnel decompression - a prospective randomised study of the Indiana Tome and a standard limited palmar incision. J Hand Surg Eur Vol 2008;33(3):332-6. 98. Hamed AR, Makki D, Chari R, Packer G. Double- versus single-incision technique for open carpal tunnel release. Orthopedics 2009;32(10). 99. Vanni D, Sirabella FS, Galzio R, Salini V, Magliani V. The double tunnels technique: an alternative minimally invasive approach for carpal tunnel syndrome. J Neurosurg 2015;123(5):1230-7. 100. Ucar BY, Demirtas A, Bulut M, Azboy I, Ucar D. Carpal tunnel decompression: two different mini-incision techniques. Eur Rev Med Pharmacol Sci 2012;16(4):533-8. 101. Xu L, Huang F, Hou C. Treatment for carpal tunnel syndrome by coronal Z-type lengthening of the transverse carpal ligament. J Pak Med Assoc 2011;61(11):1068-71. 102. Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol 2010;223(1):192-202. 103. Hochberg J. A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release. J Hand Ther 2001;14(3):208-15. 104. Janssen RG, Schwartz DA, Velleman PF. A randomized controlled study of contrast baths on patients with carpal tunnel syndrome. J Hand Ther 2009;22(3):200-7; quiz 8. 105. Jeffrey SL, Belcher HJ. Use of Arnica to relieve pain after carpal-tunnel release surgery. Altern Ther Health Med 2002;8(2):66-8. 106. Jerosch-Herold C, Shepstone L, Miller L. Sensory relearning after surgical treatment for carpal tunnel syndrome: a pilot clinical trial. Muscle Nerve 2012;46(6):885-90. 107. Martins RS, Siqueira MG, Simplicio H. Wrist immobilization after carpal tunnel release: a prospective study. Arq Neuropsiquiatr 2006;64(3A):596-9. 108. Pomerance J, Fine I. Outcomes of carpal tunnel surgery with and without supervised postoperative therapy. J Hand Surg [Am] 2007;32(8):1159-63; discussion 64-5. 109. Ritting AW, Leger R, O'Malley MP, Mogielnicki H, Tucker R, Rodner CM. Duration of postoperative dressing after mini-open carpal tunnel release: a prospective, randomized trial. J Hand Surg Am 2012;37(1):3-8. 110. Stevinson C, Devaraj VS, Fountain-Barber A, Hawkins S, Ernst E. Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery. J R Soc Med 2003;96(2):60-5.
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111. Williams AM, Baker PA, Platt AJ. The impact of dressings on recovery from carpal tunnel decompression. J Plast Reconstr Aesthet Surg 2008;61(12):1493-5. 112. Powell F. Desensitisation techniques: do they reduce scar sensitivity following carpal tunnel release? (A pilot study). Unpublished Masters Thesis 2003. 113. Sawan SA, Sayed Mahmoud HM, Hussien MM. Effect of different physical therapy modalities on post-operative recovery following transverse carpal ligament release: a randomized controlled trial. Physiotherapy Practice and Research 2013;34(2):75–82. 114. Alves MPT, Araujo GCS. Low-level laser therapy after carpal tunnel release. Revista Brasileira de Ortopedia 2011;46(6):697–701. 115. Bhatia R, Field J, Grote J, Huma H. Does splintage help pain after carpal tunnel release? J Hand Surg Br 2000;25(2):150. 116. Bury TF, Akelman E, Weiss AP. Prospective, randomized trial of splinting after carpal tunnel release. Ann Plast Surg 1995;35(1):19-22. 117. Cebesoy O, Kose KC, Kuru I, Altinel L, Gul R, Demirtas M. Use of a splint following open carpal tunnel release: a comparative study. Adv Ther 2007;24(3):478-84. 118. Cook AC, Szabo RM, Birkholz SW, King EF. Early mobilization following carpal tunnel release. A prospective randomized study. J Hand Surg [Br] 1995;20(2):228-30. 119. Fagan DJ, Evans A, Ghandour A, Prabhkaran P, Clay NR. A controlled clinical trial of postoperative hand elevation at home following day-case surgery. J Hand Surg Br 2004;29(5):458-60. 120. Finsen V, Andersen K, Russwurm H. No advantage from splinting the wrist after open carpal tunnel release. A randomized study of 82 wrists. Acta Orthop Scand 1999;70(3):28892. 121. Huemer GM, Koller M, Pachinger T, Dunst KM, Schwarz B, Hintringer T. Postoperative splinting after open carpal tunnel release does not improve functional and neurological outcome. Muscle Nerve 2007;36(4):528-31. 122. Provinciali L, Giattini A, Splendiani G, Logullo F. Usefulness of hand rehabilitation after carpal tunnel surgery. Muscle Nerve 2000;23(2):211-6. 123. Li GF, Tian DH, Yu JL, Li WZ, Meng J. Synergistic effects of compound physical factor treatment on neurological outcome after peripheral nerve entrapment surgery - A randomized controlled study. Neural Regeneration Research 2008;3(1):97-100. 124. Shalimar A, Nor-Hazla MH, Arifaizad A, Jamari S. Splinting after Carpal Tunnel Release: Does it really Matter? Malaysian Orthopaedic Journal 2015;9(2). 125. Duncan KH, Lewis RC, Jr., Foreman KA, Nordyke MD. Treatment of carpal tunnel syndrome by members of the American Society for Surgery of the Hand: results of a questionnaire. J Hand Surg Am 1987;12(3):384-91.
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Figure 1: Flow chart of the literature search
27
ACCEPTED MANUSCRIPT Table 1: Best-evidence synthesis - levels of scientific evidence.20
The level of evidence was ranked and divided in the following levels:
RI PT
6
SC
5
M AN U
4
TE D
3
EP
2
Strong evidence for effectiveness: consistent (i.e. ≥75% of the trials report the same findings) positive (significant) findings within multiple higher quality RCTs. Moderate evidence for effectiveness: consistent positive (significant) findings within multiple lower quality RCTs and/or 1 high-quality RCT. Limited evidence for effectiveness: consistent positive (significant) findings within 1 low-quality RCT. Conflicting evidence for effectiveness: provided by conflicting (significant) findings in the RCTs (<75% of the studies report consistent findings). No evidence found for effectiveness of the inventions: RCTs available, but no (significant) differences between intervention and control groups were reported. No systematic review or RCT found.
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1
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Blinding? Caregiver?
Blinding? Outcome assessors?
Incomplete outcome data addressed? Dropouts?
Incomplete outcome data? ITT analysis?
Free of suggestions of selective outcome reporting?
Similarity of baseline characteristics?
Co-interventions avoided or similar?
Compliance acceptable in all groups?
Timing of the outcome assessment similar?
Maximum score
Study score
+ + + +
+ + -
-
+ + + +
+ + + +
+ + + +
+ + + +
? + ?
+ ? ? +
NA NA NA ?
+ + + +
11 11 11 12
9 8 8 8
82 73 73 67
+ + + ? + + + + + +
+ + + ? ? ? ? ? + ?
+
-
+ + ? ? ? + ? + ? ?
+ + + + + + + +
+ ? + + + + + + +
+ + + ? + + + + + +
+ ? + + + + + ? + ?
+ ? + + ? ? ? ?
NA NA ? NA NA NA NA NA NA
+ ? + + + + + + + +
12 11 11 12 11 11 11 11 11 11
8 7 7 7 6 6 6 6 6 6
67 64 64 58 55 55 55 55 55 55
+ + + ? + + + ? + ? ? ? ? ? ? ? ?
? ? + ? ? ? ? + ? ? ? ? ? ? ? ? ? ?
+ ? ? ? ? -
? -
? ? ? ? + ? + ? ? ? ? ? ? ?
+ + + + + + + ? + ? ? ? ? ? ? + ?
+ + + + + ? ? ? ? + ? ? ? ? ? ?
+ + + + + + + + + + + + + + + + +
+ ? ? + + + ? ? ? + ? ? ? ? ? + ? ?
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? -
NA NA NA NA ? NA NA NA NA NA NA NA NA NA NA NA NA NA NA
+ + + + + + + + + ? + + + + +
11 11 11 11 12 11 11 11 11 11 11 11 11 11 11 11 11 11 11
5 5 5 5 5 4 4 4 4 3 3 3 2 2 2 2 2 2 2
45 45 45 45 42 36 36 36 36 27 27 27 18 18 18 18 18 18 18
SC
M AN U
TE D
AC C
+ = yes: - = no: ? = unsure: NA = not attempted
Percentage
Blinding? Patients?
+ + + +
RI PT
Allocation concealment?
94
Crnkovic et al 86 Padua et al 92 Suppaphol et al Fernandez-de-las32 Penas et al 33 Jarvik et al 62 Atroshi et al 93 Cho et al 124 Shalimar et al 23 Ejiri et al 63 Gumustas et al 36 Ismatullah et al 24 Kang et al 30 Ly-Pen et al Siegmeth and 83 Hopkinson-Woolley 37 Chandra et al 74 Elsharif et al 84 Forward et al 82 Tarallo et al 25 Ucan et al 96 Acar et al 95 Castillo and Yao 98 Hamed et al 69 Larsen et al 97 Cresswell et al 64 Michelotti et al 99 Vanni et al 35 Andreu et al 22 Aslani et al 75 Heidarian et al 85 Stepic et al 100 Ucar et al 101 Xu et al 65 Zhang et al
EP
Reference
Adequate randomization?
Table 2: Methodological quality scores of the included RCTs
ACCEPTED MANUSCRIPT 14
+ + +
+ + + + + ? ?
+ + + ? ? ?
+ + + ? + ?
7 7 7 7 7 7 7
5 5 3 3 2 2 2
71 71 43 43 29 29 29
? + ? ? ? ? ? ?
? ? ? ? ? ?
-
+ + + -
? ? ? + ? ? + + +
? ? ? ? ? -
+ + ? ? ? + ? ? ?
7 7 7 7 7 7 7 7 7
2 2 1 1 1 1 1 1 1
29 29 14 14 14 14 14 14 14
? ? ?
?
-
-
? -
? ? ?
? ?
7 7 7
0 0 0
0 0 0
? ? ? ?
? ? ? ?
-
-
? ? ? ?
? ? ? ?
? ? ?
7 7 7 7
0 0 0 0
0 0 0 0
? ? ? ? ?
? ? ? ?
-
-
? ? ? ?
? ? ? ? ?
? ? ? ? ?
7 7 7 7 7
0 0 0 0 0
0 0 0 0 0
Percentage
Study score
SC
M AN U
TE D
AC C 14
RI PT
Incomplete outcome data
-
Maximum score
Blinding outcome assessment
+ + ? ? ? ?
Other bias
Blinding participants and personnel
+ + ? + + +
Selective reporting
Allocation concealment?
38
Atroshi et al 39 Tüzüner et al 46 Hoefnagels et al 50 Saw et al 40 Sennwald et al 41 Brown et al Ferdinand and 44 MacLean 54 Trumble et al 67 Wong et al 57 Incoll et al 47 Jacobsen et al 48 Macdermid et al 61 Malhotra et al 49 Rab et al 51 Schäfer et al Stark and Engkvist52 Löfmark 10 Agee et al 42 Dumontier et al Eichhorn and 68 Dieterich 43 Erdmann 45 Foucher et al 56 Giele et al Koskella and 58 Alexander 66 Mackenzie et al 59 Sørensen et al 53 Tian et al 60 Werber et al 55 Westphal et al
EP
Reference
Random sequence generation
Table 3: Methodologic quality scores of the Cochrane Review of Vasiliadis et al
The review of Vasiliadis et al applied for the methodologic quality scores the methodological quality 27 criteria of the Cochrane Collaboration's Tool + = yes: - = no: ? = unsure
ACCEPTED MANUSCRIPT 16
Assessment timing similar?
Intention to treat analysis?
? + NA + NA NA ? NA
+ + + + ? ?
+ + + + ? + ? ?
+ + + + + + ? ?
+ + ? -
M AN U
TE D
16
9 9 8 9 8 8 9 8
Percentage
Drop-out rate described and acceptable?
+ + ? + + ? ? ?
Study score
Blinding outcome assessors?
+ + ? + + ? ?
RI PT
Blinding patient?
? ? + + ? ? ?
Maximum score
Co-interventions avoided or similar?
+ + + + + + + ?
SC
Similar at baseline?
90
Leinberry et al 89 Mackinnon et al 78 Jugovac et al 88 Lowry et al 70 Bhattacharya et al 71 Helm et al 91 Shum et al Eichhorn and 68 Dieterich
Allocation concealment?
Reference
Randomization?
Table 4: Methodologic quality scores of the Cochrane Review of Scholten et al
7 7 6 6 5 4 1 0
78 78 75 67 63 50 11 0
AC C
EP
The review of Scholten et al applied for the methodologic quality scores the methodological quality 20 criteria of van Tulder et al + = yes: - = no: ? = unsure: NA = not attempted
ACCEPTED MANUSCRIPT 7
7
RI PT
SC
Percentage
NA NA NA NA
Study score
+ + + NR
Maximum score
+ + + ?
M AN U
Patient blinded?
+ + + +
Observer blinded?
Baseline differences?
30
Ly-Pen et al 29 Gerritsen et al 31 Hui et al 28 Garland et al
Allocation concealment?
Reference
Randomization?
Table 5: Methodologic quality scores of the Cochrane Review of Verdugo et al
NA NA
3 4 4 3
3 3 3 1
100 75 75 33
The review of Verdugo et al applied for the methodologic quality scores the methodological quality 26 criteria of Schultz et al
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+ = yes: - = no: ? = unsure: NA = not attempted: NR = not reported
ACCEPTED MANUSCRIPT 17
Blinding self-reported outcomes
Blinding other outcomes
Incomplete outcome data 12 weeks or less
Incomplete outcome data after 12 weeks
Selective reporting
Other bias
Maximum score
Study score
Percentage
+ + ?
+ ? +
+ + +
+ + +
+ + +
NA NA NA
+ + +
+ + +
7 7 7
7 6 6
100 86 86
+
+
-
+
+
?
+
+
8
6
75
+
+
-
+
+
+
-
+
8
6
75
+ + + -
+ + -
+ +
+ + + -
+ + + +
? NA +
+ + + +
+ ? + +
8 8 7 8
6 6 5 5
75 75 71 63
+ + + + + ? + ? ? -
? ? ? ? ? ? ? ? ? ? -
-
+ + ? ? ? ? ? ? + ? ?
+ + + + + ? + NA + ? ? -
NA NA NA + NA NA ? NA NA ? -
+ + + + + + -
+ + + + + + + + + + + + +
7 7 7 8 7 7 8 8 7 7 7 8 8
4 4 4 4 3 3 3 3 2 2 2 1 1
57 57 57 50 43 43 38 38 29 29 29 13 13
SC
M AN U
TE D
AC C 17
RI PT
Allocation concealment?
112
Powell et al 104 Janssen et al Jeffrey and 105 Belcher Jerosch-Herold 106 et al Pomerance and 108 Fine 113 Sawan et al 110 Stevinson et al 111 Williams et al Alves and 114 Araujo 103 Hochberg et al 107 Martins et al 109 Ritting et al 102 Gordon et al 117 Cebesoy et al 119 Fagan et al 115 Bhatia et al 123 Li et al 116 Bury et al 121 Huemer et al 122 Provinciali et al 118 Cook et al 120 Finsen et al
EP
Reference
Random sequence generation
Table 6: Methodologic quality scores of the Cochrane Review of Peters et al
The review of Peters et al applied for the methodologic quality scores the methodological quality 27 criteria of the Cochrane Collaboration's Tool + = yes: - = no: ? = unsure: NA = not attempted
ACCEPTED MANUSCRIPT Table 7: Strong and Moderate Evidence for Effectiveness of Surgical Interventions for CTS Surgery to treat carpal tunnel syndrome Surgery vs non-surgical √a,b,c,d,e,f,g Timing of surgery 0 Various surgical techniques √ h,i Post-surgical √j,k
RI PT
√: strong or moderate evidence found; 0: RCT(s) found, but only limited, conflicting or no evidence for effectiveness of interventions was found. Short-term: Strong evidence: surgical treatment vs corticosteroid injections* f Moderate evidence: surgical treatment vs manual therapy* h Moderate evidence: corticosteroid irrigation of the median nerve before skin closure as additive to carpal tunnel release i Moderate evidence: direct vision plus tunneling technique* vs standard open carpal tunnel release j Moderate evidence: short dressing* vs long duration bulky dressing k Moderate evidence: postoperative sensory retraining program* vs no program Midterm: a Moderate evidence: surgical treatment* vs splinting d Moderate evidence: surgical treatment* vs anti-inflammatory drugs plus hand therapy g Moderate evidence: surgical treatment vs manual therapy* Long-term: b Moderate evidence: surgical treatment* vs splinting e Moderate evidence: surgical treatment* vs anti-inflammatory drugs plus hand therapy * in favor of
AC C
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c
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Table 8. Complete overview of evidence for effectiveness of surgical interventions for carpal tunnel syndrome
++ ++
++ ++ NE
RI PT
Post-operative ►Short* vs long duration bulky dressing Short-term: ►Postoperative sensory retraining program* vs non Short-term: ►Ultrasound plus exercise vs laser therapy plus exercise Short-term: ►Ultrasound plus exercise vs exercise alone Short-term: ►Laser therapy plus exercise vs exercise alone Short-term: ►Low level laser vs placebo Short-term: Midterm: ►Splint vs (soft) bulky dressing Short-term: Midterm: ►Specialized home elevation device vs standard sling Short-term: Midterm:
SC
± ± ±
± NE NE
M AN U
TE D
+++ NE +
EP
± ++ ++
SURGICAL TREATMENT Timing of surgery Various surgical techniques ►Early surgery* ►Endoscopic* vs standard <1wk after open carpal tunnel release diagnosis Short-term: vs delayed Midterm: surgery >6mo Long-term: after ►Endoscopic vs miniopen diagnosis carpal tunnel release Midterm: + Short-term: Long-term: + Midterm: Long-term: ►One-portal endoscopic vs open carpal tunnel release Short-term: Midterm: Long-term: ►Two-portal endoscopic vs open carpal tunnel release Short-term: Midterm: Long-term: ►Mini-open technique assisted by Knifelight Instrument* vs standard open release Short-term: Midterm: Long-term: ►Modified open* vs standard open release incision Short-term: Midterm: Long-term:
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Surgical vs non-surgical ►Surgical treatment* vs splinting Short-term: Midterm: Long-term : ►Surgical treatment vs corticosteroid* injections Short-term: Midterm: Long-term : ►Surgical treatment* vs anti-inflammatory drugs plus handtherapy (plus ultrasound in cases not responding to handtherapy) Midterm : Long-term: ►Surgical treatment vs manual therapy* Short-term: Midterm: Long-term:
± ± NE
± ± ±
NE NE +
± ± ±
++
++
NE
NE
NE
NE NE
NE NE
NE NE
ACCEPTED MANUSCRIPT
RI PT
SC
NE NE
►Controlled cold therapy vs ice therapy Short-term: Midterm: ►Bulky dressing plus splint vs light dressing Short-term: ►Contrast bath plus exercise vs no exercise Short-term: Midterm: ►Arnica vs placebo ►High dosis arnica vs low dosis Short-term: Midterm: ►Multi-modal hand therapy vs normal activities/exercise Short-term: Midterm:
NE
AC C
EP
TE D
M AN U
►Nerve- preserving decompression vs standard decompression of the carpal tunnel Short-term: Midterm: ►Open carpal tunnel release with vs without preservation of the ulnar bursa Short-term: ►Open carpal tunnel release with perineural steroid injection immediately after decompression vs no perineural steroid injection after decompression Short-term: ►Corticosteroid irragiation* of the median nerve before skin closure as additive to carpal tunnel release: Short-term: ►With vs without lengthening of the flexor retinaculum in open carpal tunnel release Short-term: Midterm: ► With vs without internal neurolysis in open carpal tunnel release Short-term:
NC
++
NE NE
NE
NE NE
NE
NE NE
NE NE
NE NE
ACCEPTED MANUSCRIPT
SC
NE
RI PT
NE
++
AC C
EP
TE D
M AN U
►With vs without epineurotomy in open carpal tunnel release Long-term: ►With vs without tenosynovectomy in open carpal tunnel release Long-term: ►Direct vision plus tunneling technique* vs standard open carpal tunnel release Short-term: ►Short wrist transverse vs limited open technique Long-term: ►Transverse carpal ligament releasing with vs without distal forearm fascia releasing Long-term: ►Mini-open Technique using the Biomet TM Indiane Tome vs standard open limited incision Short-term: Long-term: ►Double tunnels technique* vs standard open technique Short-term: Midterm: Long-term: ►Subneural reconstruction of the transverse carpal ligament* vs endoscopic carpal tunnel release
NE
NE
NE NE
± ± +
ACCEPTED MANUSCRIPT
SC
+ + +
RI PT
+ + +
NE
M AN U
Short-term: Midterm: Long-term: ►Subneural reconstruction of the transverse carpal ligament* vs open carpal tunnel release Short-term: Midterm: Long-term: ►Incision distal vs proximal to flexor crease Short-term: ►Coronal Z-type lengthening of the transverse carpal ligament* vs standard open approach Short-term: Midterm: Long-term:
NE + +
AC C
EP
TE D
Abbreviations: vs, versus; wk, weeks; mo, months. X: No systematic review (SR) or randomized clinical trial (RCT) found. +: limited evidence found; ++: moderate evidence found; +++: strong evidence found; ±: conflicting evidence for effectiveness. NC: RCT was found, but no comparison was made between the intervention and control groups, thus no evidence was found. NE: no evidence found for effectiveness of the treatment: RCT(s) available, but no differences were found between intervention and control groups. *: in favor of. Different surgical techniques: Open carpal tunnel release: the carpal tunnel ligament is divided by a (5 cm) palmar incision. Modified open carpal tunnel release: the carpal tunnel ligament is divided by a (5 cm) palmar incision with preservation of superficial nerve branches crossing the incision site. Mini-open carpal tunnel release: the carpal tunnel ligament is divided by a smaller (1-2 cm) palmar incision. Miniopen technique assisted by Knifelight instrument: a special knife with a battery-operated trans illuminating light source introduced through a small, proximal or distal incision. Endoscopic carpal tunnel release: division of the transverse carpal ligament with the use of an endoscopic camera, optic fiber light source and monitor performed with one or two portals, whilst leaving overlying structures intact. Single portal endoscopic carpal tunnel release: one small incision (portal) proximal or distal to the carpal tunnel to indirect access to the bottom surface of the transverse ligament. Two portal endoscopic carpal tunnel release: two small incision (portal) proximal or distal to the carpal tunnel to indirect access to the bottom surface of the transverse ligament.
AC C
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SC
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Appendix 1: Systematic reviews: CTS No. of patients/ hands
Treatment
Control/ Comparison
Outcome Measures
Effect Size
Splinting
Clinical improvement
3mo: RR=1.38 (95% CI, 1.08 to 1.75)
RI PT
Author
Surgical versus nonsurgical Surgery
SC
349
Steroid injection
Clinical improvement
TE D
Surgery
2586
Endoscopic (twoor one-portal) carpal tunnel release
AC C
Vasiliadis et 14 al (28 RCTs)
EP
Grip strength
Various surgical techniques
(1 RCT) in favor of surgery 6mo: RR=1.29 (95% CI, 1.08 to 1.55) (1 RCT) in favor of surgery 1 year: RR=1.27 (95% CI, 1.05 to 1.53) (2 RCTs) in favor of surgery 3mo: RR=.66 (95% CI, .49 to .90) in favor of steroid injection 3mo: RR=2.18 (95% CI, 1.39 to 3.42) (2 RCTs) in favor of steroid injection 6mo: RR=.95 (95% CI, .71 to 1.29) (1 RCT) 1y: not significant (no RR given) 20wk: RR=.71 (95% CI, .43 to 1.15)
M AN U
Verdugo et 7 al (4 RCTs)
Open carpal tunnel release
Overall improvement Symptom severity scale (Levine)
Function status scale (Levine)
> 3mo: RR=1.05 (95% CI, .96 to 1.15) ≤ 3mo: WMD= -.09 (95% CI, -.48 to .30) > 3mo: WMD=.02 (95% CI, -.18 to .22) ≤ 3mo: WMD=-.19 (95% CI, -.61 to .23) > 3mo: WMD=.01 (95% CI, -.14 to
ACCEPTED MANUSCRIPT
RI PT
Pain
M AN U
Modified open carpal tunnel release
Overall improvement
Symptom severity scale (Levine) Function status scale (Levine) Pain
EP
TE D
Endoscopic (twoor one-portal) carpal tunnel release
SC
Numbness
Grip strength
AC C
Grip strength
Two-portal endoscopic carpal tunnel release
.16) ≤ 3mo: WMD=-.41 (95% CI, -.65 to -.18) in favor of endoscopic release RR=.49 (95% CI, .21 to 1.15) > 3mo: MD=-5.20 (95% CI, -12.65 to 2.25) RR=.88 (95% CI, .57 to 1.38) ≤ 3mo: RR=1.14 (95% CI, .76 to 1.71) > 3mo: MD=.06 (95% CI, -.04 to .16) RR=.64 (95% CI, .31 to 1.35) ≤ 3mo: WMD=.40 (95% CI, .10 to .71) in favor of endoscopic release > 3mo: WMD=1.13 (95% CI, .56 to 1.71) in favor of endoscopic release ≤ 3mo: RR=1.11 (95% CI, .89 to 1.38) > 3mo: RR=.89 (95% CI, .59 to 1.35) ≤ 3mo: MD= -.37 (95% CI, -1.01 to .27) ≤ 3mo: MD=-.48 (95% CI, -1.14 to .17) ≤ 3mo: WMD=.01 (95% CI, -1.07 to 1.08) RR=2.0 (95% CI, 1.01 to 3.95) in favor of modified open release ≤ 3mo: MD=.14 (95% CI, -.48 to .76) ≤ 3mo: OR=1.35 (95% CI, .71 to 2.55) >3mo: OR=1.00 (95% CI, .49 to 2.02)
Open (standard or modified) carpal tunnel release
Overall improvement
Symptom severity scale (Levine) Function status scale (Levine)
≤ 3mo: WMD= -.08 (95% CI, -.39 to .22) > 3mo: MD=.03 (95% CI, -.21 to .27) ≤ 3mo: WMD=-.16 (95% CI, -.60 to .29)
ACCEPTED MANUSCRIPT
RI PT
Pain
> 3mo: MD=.01 (95% CI, -.16 to .18) ≤ 3mo: WMD=-.18 (95% CI, -.96 to .59) OR=1.18 (95% CI, .50 to 2.78) > 3mo: MD=-5.20 (95% CI, -12.65 to 2.25) RR=.91 (95% CI, .39 to 2.14) ≤ 3mo: OR=1.12 (95% CI, .55 to 2.28) ≤ 3mo: WMD=.27 (95% CI, .02 to .53) in favor of two-portal endoscopic release > 3mo: MD=.76 (95% CI, -.32 to 1.84) > 3mo: OR=2.05 (95% CI, .74 to 5.69) ≤ 3mo: WMD= -.12 (95% CI, -.66 to .42) > 3mo: MD=.00 (95% CI, -.35 to .35) ≤ 3mo: WMD=-.25 (95% CI, -.82 to .32) > 3mo: MD=.0 (95% CI, -.29 to .29) ≤ 3mo: MD=-.31 (95% CI, -.63 to .02) OR=.06 (95% CI, .02 to .22) in favor of one-portal endoscopic release >3mo: OR=.80 (95% CI, .38 to 1.69) ≤ 3mo: OR=1.30 (95% CI, .62 to 2.71) > 3mo: MD=.06 (95% CI, -.04 to .16) OR=.60 (95% CI, .26 to 1.42) ≤ 3mo: WMD=.50 (95% CI, -.14 to 1.13) > 3mo: MD=1.28 (95% CI, .60 to 1.96) in favor of endoscopic release ≤ 3mo: RR=1.00 (95% CI, .83 to 1.20)
One-portal endoscopic carpal tunnel release
Open (standard or modified) carpal tunnel release
M AN U
SC
Numbness Grip strength
Overall improvement Symptom severity scale (Levine)
TE D
Function status scale (Levine)
EP
Pain
AC C
Numbness
Scholten et 16 al
2021
Open: modified
Open: standard
Grip strength
Overall improvement
ACCEPTED MANUSCRIPT
≤ 3mo: RR=1.02 (95% CI, .68 to 1.54) > 3mo: RR=.92 (95% CI, .74 to 1.14)
Overall improvement
After 3mo: RR=.93 (95% CI, .58 to 1.50) After 3mo: WMD=.00 (95% CI, .29 to .29) After 3mo: WMD=.10 (95% CI -.18 to .38)
RI PT
Overall improvement
SC
Placebo
≤ 3mo: OR=.76 (95% CI, .14 to 4.28)
Symptom severity score (Levine) Functional status score (Levine)
M AN U
1521
Postsurgical interventions Low-level laser
Overall improvement
Palmar pain Numbness
TE D
17
incision Open: without Knifelight instrument Open: without internal neurolysis Open: without epineurotomy Open: without tenosynovectomy
Paraesthesia Scar pain
EP
Peters et al (22 RCTs)
incision Open: with Knifelight instrument Open: with internal neurolysis Open: with epineurotomy Open: with tenosynovectomy
Pillar pain
Immobilisation (splint) Immobilisation (plaster or Paris splint)
AC C
(8 RCTs)
Mobilisation (bulky dressing) Bulky dressing and mobilisation
Symptom free Improved or cured Boston Carpal Tunnel Questionnaire, functional status score Boston Carpal Tunnel Questionnaire, symptom severity score
3mo: RR=.33 (95% CI, .01 to 7.86) 6mo: RR=1.0 (95% CI, .07 to 15.24) 3mo: RR=.14 (95% CI, .01 to 2.65) 6mo: RR=.2 (95% CI, .01 to 3.99) 3mo: RR=.14 (95% CI, .01 to 2.65) 6mo: RR=.2 (95% CI, .01 to 3.99) 3mo: RR=.33 (95% CI, .04 to 3.02) 6mo: RR=.33 (95% CI, .01 to 7.86) 3mo: RR=.67 (95% CI, .21 to 2.12) 6mo: RR=.33 (95% CI, .01 to 7.86) 6mo: RR=.94 (95% CI, .52 to 1.70) 6mo: RR=.90 (95% CI, .76 to 1.06) 3mo: MD=.39 (95% CI, -.45 to 1.23)
3mo: MD=1.60 (95% CI, -.12 to 3.32)
ACCEPTED MANUSCRIPT
Scar discomfort
6w: RR=.95 (95% CI, .59 to 1.54) 6mo: RR=1.19 (95% CI, .42 to 3.38) 1mo: RR=2.4 (95% CI, .99 to 5.81) 6wk: RR=1.25 (95% CI, .39 to 3.99) 6mo: RR=3.57 (95% CI, .39 to 32.87) 6wk: RR=2.5 (95% CI, .24 to 26.48) 6mo: RR=1.19 (95% CI, .08 to 18.36) 3mo: RR=5.0 (95% CI, .25 to 99.16)
RI PT
Pillar pain Hypothenar pain
Light dressing
Scar pain
Normal activities/ exercise
Disabilities of the Arm, Shoulder and Hand Grip strength Lateral pinch strength
TE D
Boston Carpal Tunnel Questionnaire, functional status score Boston Carpal Tunnel Questionnaire, symptom severity score Pain or discomfort
EP
Short duration dressing
No treatment
Extended duration dressing
AC C
Desensitization therapy (as part of multiple interventions)
6mo: MD=1.0 (95% CI, -4.44 to 6.44) 12wk: MD=-.60 (95% CI, -3.43 to 2.23) 6mo: MD=-.40 (95% CI, -3.59 to 2.79) 12wk: MD=-.20 (95% CI, -.97 to .57) 6mo: MD=-.20 (95% CI, -.94 to .54) 12wk: MD=-.03 (95% CI, -.39 to .33)
M AN U
Bulky dressing plus splint Multi-modal hand therapy
SC
Thenar pain
Grip strength Scar sensitivity Grip strength
Tip pinch strength
3-point pinch strength Lateral pinch strength
6wk: MD=.02 (95% CI, -.35 to .39)
12wk: MD=4.9 (95% CI, -14.69 to 24.49) 12wk: MD=-.80 (95% CI, -7.38 to 5.78) 12wk: MD=-.67 (95% CI, -1.46 to .12) 6 to 12wk: MD=-16.0 (95% CI, -21.57 to -10.43) in favor of short duration dressing 6 to 12wk: MD=-1.20 (95% CI, -2.35 to -.05) in favor of short duration dressing 6 to 12wk: MD=-1.10 (95% CI, -2.28 to .08) 6 to 12wk: MD=-.70 (95% CI, -1.88 to
ACCEPTED MANUSCRIPT
Continues ultrasound plus exercises
Laser therapy plus exercises
Continues ultrasound plus exercises
Exercises alone
Laser therapy plus exercises
Exercises alone
Disabilities of the Arm, Shoulder and Hand Pinch strength Pain
Pinch strength Pain
TE D
Pinch strength
AC C
EP
Pain
8wk: MD=-2.17 (95% CI, -4.59 to .25) 8wk: MD=1.94 (95% CI, .68 to 3.20) in favor of sensory retraining 8wk: MD=6.31 (95% CI, 1.14 to 11.48) in favor of sensory retraining 8wk: MD=-12.86 (95% CI, -30.91 to 5.19) 6wk: MD=1.40 (95% CI, .23 to 2.57) in favor of laser 6wk: MD=-.60 (95% CI, -1.05 to -.15) in favor of ultrasound 6wk: MD=4.0 (95% CI, 3.14 to 4.86) in favor of exercises 6wk: MD=-.1.80 (95% CI, -2.30 to -1.30) in favor of ultrasound 6wk: MD=2.60 (95% CI, 1.49 to 3.71) in favor of exercises 6wk: MD=-.1.20 (95% CI, -1.75 to -.65) in favor of laser
RI PT
Weinstein Enhanced Sensory Test 2-points discrimination Shape-Texture Identification test Locognosia test
SC
Control
M AN U
Sensory retraining programme
.48) 8wk: MD=.37 (95% CI, -.14 to .88)
ACCEPTED MANUSCRIPT
Appendix 2. Recent RCTs – CTS Treatment
Control/Comparison
Outcome Measures (Total Follow-Up Time)
Results Statistical
Non-surgical therapy: Local corticosteroid injection (n=83)
Nocturnal paraesthesias (VAS) (24mo) Diurnal pain (VAS) (24mo)
P<.001
Surgery: carpal tunnel release (n=20)
Non-surgical therapy: Local corticosteroid injection (n=20)
35
Surgery: carpal tunnel release, limited palmar incision technique (n=80)
Non-surgical therapy: Local corticosteroid injection (n=83)
P=.19
Surgical: mean ± SD, 1.29±7.26, vs nonsurgical: 3.04±6.54 at 24mo follow-up
P=.008
Surgical: mean ± SD, 2.02±7.23, vs nonsurgical: 6.21±8.81 at 24mo follow-up
Global Symptom score (12wk)
P=.794
Surgical: mean ± SD, 35.45000±7.43020, vs nonsurgical: 34.8000±8.14733 at baseline Surgical: mean ± SD, 12.5000±7.28011, vs nonsurgical: 11.6000±6.90080 at 2w follow-up Surgical: mean ± SD, 7.3000±5.67636, vs nonsurgical: 9.8500±6.39305 at 4wk follow-up Surgical: mean ± SD, 5.450±6.9014, vs nonsurgical: 22.100±6.8970 at 12wk follow-up
AC C
Andreu et al
Surgical: mean ± SD, 1.38±4.51, vs nonsurgical: 8.81±13.95 at 24mo follow-up
Self-perceived functional impairment (24mo)
EP
Ismatullah et 36 al
Surgery: Carpal tunnel release, limited palmar incision technique (n=80)
M AN U
34
TE D
Ly-Pen et al
SC
Surgical vs nonsurgical
Results by Outcome Measure
RI PT
Author
Functional impairment (VAS) (12mo)
P=.690
P=.190
P=.000
P=.793 P=.003
Surgical: mean ± SD, 39±28, vs nonsurgical: 38±26 at baseline Surgical: mean ± SD, 17±23, vs nonsurgical: 6±13 at 3mo follow-up
ACCEPTED MANUSCRIPT
P=.701
Pain (VAS)(12mo)
P=.951 P=.008
SC
P=.302
RI PT
P=.014
Surgical: mean ± SD, 7±15, vs nonsurgical: 8±15 at 6mo follow-up Surgical: mean ± SD, 3±11, vs nonsurgical: 9±15 at 12mo follow-up Surgical: mean ± SD, 42±30, vs nonsurgical: 42±29 at baseline Surgical: mean ± SD, 15±22, vs nonsurgical: 6±15 at 3mo follow-up Surgical: mean ± SD, 5±16, vs nonsurgical: 8±18 at 6mo follow-up Surgical: mean ± SD, 2±10, vs nonsurgical: 8±15 at 12mo follow-up Surgical: mean ± SD, 56±29, vs nonsurgical: 58±29 at baseline Surgical: mean ± SD, 16±25, vs nonsurgical: 8±17 at 3mo follow-up Surgical: mean ± SD, 7±17, vs nonsurgical: 13±21 at 6mo follow-up Surgical: mean ± SD, 3±11, vs nonsurgical: 12±19 at 12mo followup
M AN U
P=.018 Nocturnal paraesthesias (VAS) (12mo)
P=.584 P=.041
Splinting in neutral position with standard cotton-polyester, day and night for 3mo (group 1; n=23)
Local steroid injection into the carpal tunnel (20mg triamcinolone acetonide and 20mg lidocaine) after 3mo of splinting (group 2) (n=23)
Boston Questionnaire Symptom severity scale (6mo)
EP
25
AC C
Ucan et al
TE D
P=.060 P=.002
NS, no P value given
Group 1: from mean ± SD, 2.66±.35 at baseline to 1.39±0.37 at 3mo vs group 2: from 2.79±.63 at baseline to1.41±.32 at 3mo vs group 3: from 3.09±0.5 at baseline to1.86±0.6 at 3mo
P=.004
Group 1: from mean ± SD, 2.66±.35 to 1.54±.31 at 6mo vs group 2: from 2.79±.63 at baseline to 1.96±.63 at 6mo vs group 3*:3.09±0.5 at baseline to 1.41±.31 at 6mo Group 1: from mean ± SD,
Open carpal tunnel release (group 3; n=11)
BQ function capacity
NS, no P
ACCEPTED MANUSCRIPT
value given
Non-surgical therapy: Non-steroidal antiinflammatory drugs (ibuprofen 3 times daily 200mg) + hand therapy 6 sessions in 6wk + Splinting; ultrasound was offered in patient who did not improve at 6wk follow-up (n=59)
Pain intensity (12mo)
TE D
Surgery: open or endoscopic decompression of the carpal tunnel (n=57)
NS, no P value given P=.0993
Carpal Tunnel Syndrome Assessment Questionnaire Function score (12mo)
Surgical: mean ± SD, 6.6±2.6, vs nonsurgical: 6.8±2.5 at baseline Surgical: mean ± SD, 4.7±3.2, vs nonsurgical: 5.7±3.1 at 6mo followup Treatment effect (difference between groups): MD=1.0 (95% CI, -0.2 to 2.1)
P=.1590
Surgical: mean ± SD, 3.5 ± 3.0, vs nonsurgical: 4.3±3.3 at 12mo follow-up Treatment effect (difference between groups): MD=.90 (95% CI, -0.3 to 2.1)
NS, no P value given
Surgical: mean ± SD, 2.42±.82,vs nonsurgical: 2.53±.82 at baseline
EP
33
AC C
Jarvik et al
M AN U
SC
P=.03
2.47±.65 at baseline to 1.60±0.2 at 3mo vs group 2: from 2.19±.51 at baseline to 1.32±.33 at3mo vs group 3: from 2.7±.62 at baseline to 1.85 ±.63 at 3mo Group 1: from mean ± SD, 2.47±.65 at baseline to 1.75±.26 at 6mo vs group 2: from 2.19±.51 at baseline to 1.69±.31 at 6mo vs group 3*: from 2.7±.62 at baseline to1.52±.34 at 6mo
RI PT
scale (6mo)
ACCEPTED MANUSCRIPT
Surgical: mean ± SD, 1.74±.79, vs nonsurgical: 2.17±.96 at 12mo follow-up Treatment effect (difference between groups): MD=.40 (95% CI, .11 to .70)
M AN U
SC
P=.0081
Surgical: mean ± SD, 1.91±.88, vs nonsurgical: 2.44±.87 at 6mo followup Treatment effect (difference between groups): MD=.46 (95% CI, .20 to .72)
RI PT
P=0.006
NS, no P value given P=.0181
Carpal tunnel release (n=60)
AC C
Fernándezde-las-Peñas 32 et al
3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system
Mean level of hand pain (NPRS) (12mo)
Surgical: mean ± SD, 2.95±.77, vs nonsurgical: 3.01±.64 at baseline Surgical: mean ± SD, 2.02±1.03, vs nonsurgical: 2.42±.80 at 6mo follow-up Treatment effect (difference between groups): MD=.42 (95% CI, .07 to .77)
P=.0357
Surgical: mean ± SD, 1.74±.76, vs non-surgical: 2.07±.88 at 12mo follow-up Treatment effect (difference groups): MD=.34 (95% CI, .02 to .65)
NS, no P value given Significant, no P value given
Surgical: mean ± SD, 4.9±2.2, vs manual therapy: 4.8±1.5 at baseline
EP
TE D
Symptom score (12mo)
Surgical: mean ± SD, 2.5±2.1, vs manual therapy: 1.1±1.8 at 3mo follow-up
ACCEPTED MANUSCRIPT
Surgical: mean ± SD, 1.8±2.5, vs manual therapy: 1.1±1.6 at 6mo follow-up Surgical: mean ± SD, 1.3±1.9, vs manual therapy: 1.2±1.8 at 12mo follow-up Surgical: mean ± SD, 7.0±2.0, vs manual therapy: 6.6±1.7 at baseline
M AN U
SC
Worst level of hand pain (NPRS) (12mo)
NS, no P value given NS, no P value given NS, no P value given Significant, no P value given Significant, no P value given NS, no P value given NS, no P value given Significant, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no
RI PT
of 30 minutes duration, once per week (n=60)
AC C
EP
TE D
Boston Questionnaire Functional status scale (12mo)
Symptom severity
Surgical: mean ± SD, 4.3±3.0 vs manual therapy: 2.3±2.6 at 3mo follow-up Surgical: mean ± SD, 3.3±3.3, vs manual therapy: 2.2±2.5 at 6mo follow-up Surgical: mean ± SD, 2.7±1.9, vs manual therapy: 2.0±1.6 at 12mo follow-up Surgical: mean ± SD, 2.4±.6, vs manual therapy: 2.3±.5 at baseline Surgical: mean ± SD, 2.3±.7, vs manual therapy: 1.5±.4 at 1mo follow-up Surgical: mean ± SD, 1.8±.7, vs manual therapy: 1.5±.5 at 3mo follow-up Surgical: mean ± SD, 1.6±.6, vs manual therapy: 1.5±.5 at 6mo follow-up Surgical: mean ± SD, 1.5±.6, vs manual therapy: 1.5±.5 at 12mo follow-up Surgical: mean ± SD, 2.7±.6, vs
ACCEPTED MANUSCRIPT
manual therapy: 2.5±.7 at baseline Surgical: mean ± SD, 1.6±.4, vs manual therapy: 1.6±.6 at 3mo follow-up
RI PT
P value given NS, no P value given NS, no P value given NS, no P value given
Surgical: mean ± SD, 1.5±.5, vs manual therapy: 1.6±.6 at 6mo follow-up Surgical: mean ± SD, 1.5±.5, vs manual therapy: 1.5±.5 at 12mo follow-up
Symptom severity score (12.8y)
P=.79
Functional status score (12.8y)
P=.27
Pain (12.8y)
P=.54
TE D
Open carpal tunnel release (n=65)
EP
62
Disabilities of the Arm Shoulder and Hand (12.8y) Numbness and/or tingling (12.8y) Numbness and/or tingling, median nerve distribution Pain in scar or proximal palm (12.8y)
AC C
Atroshi et al
Various surgical techniques Endoscopic carpal tunnel release (n=63)
M AN U
SC
scale (12mo)
P=.82
P=.80 P=.75
P=.80
MD from baseline to mean (SD), 12.8 (1.2) y: -.03 (95% CI, -.25 to .19) MD from baseline to mean (SD), 12.8 (1.2) y= .11 (95% CI, -.09 to .31) MD from baseline to mean (SD), 12.8 (1.2) y= 1.5 (95% CI, -3.5 to 6.5) MD from baseline to mean (SD), 12.8 (1.2) y= -.7 (95% CI, -6.6 to 5.2) RR=.95 (95% CI, -3.5 to 6.5) at mean (SD) 12.8 (1.2) y follow-up RR=1.14 (95% CI, .52 to 2.48) at mean (SD) 12.8 (1.2) y follow-up
RR=.86 (95% CI, .28 to 2.67) at mean (SD) 12.8 (1.2) y follow-up
ACCEPTED MANUSCRIPT
Endoscopic carpal tunnel release (n=21)
Open carpal tunnel release (n=20)
Boston Questionnaire Symptom severity scale (6mo)
P=.39 P=.75
Functional status scale (6mo)
P=.17
Open carpal tunnel release (n=50)
Degree of improvement (12wk)
P=.08
Semmes-Weinstein monofilament test Two-point discrimination test Grip strength (kg)
P=.20
TE D
Endoscopic carpal tunnel release (Okutsu method) (n=51)
M AN U
23
Ejiri et al
EP
Tip pinch strength
Endoscopic carpal tunnel release (n=25)
AC C
Side pinch strength
Michelotti et 64 al
Open carpal tunnel release (n=25)
SC
P=.49
Carpal tunnel syndrome-Functional status score (24wk)
Endoscopic: mean ± SD, 3.35±.65, vs open: 3.51±0.54 at baseline Endoscopic: mean ± SD, 1.26±.48, vs open: 1.41±0.46 at 6mo follow-up Endoscopic: mean ± SD, 3.11±.82, vs open: 3.43±0.63 at baseline Endoscopic: mean ± SD, 1.20±.35, vs open: 1.56±0.48 at 6mo follow-up
RI PT
Gümüstas et 63 al
P=.79 P=.04 P=.27 P=.09 P=.01 P=.07
P=.68 P=.29 P=.92
Endoscopic: improved/unchanged/ exacerbated, 47/2/1, versus open: 50/0/0 at 12wk follow-up Endoscopic: MD from baseline to 12w, -.49, versus open -.24 Endoscopic: MD from baseline to 12w, -3.3, versus open -1.7 Endoscopic: MD from baseline to 4wk, -4.60, versus open -8.10 Endoscopic: MD from baseline to 12wk, -1.20, versus open -3.60 Endoscopic: MD from baseline to 12wk, .07, versus open -.2 Endoscopic: MD from baseline to 4wk, .3, versus open -.8 Endoscopic: MD from baseline to 12wk, .7, versus open -.2 Endoscopic: mean, 2.27, vs open: 2.18 at baseline Endoscopic: mean, 1.18, vs open: 1.23 at 12wk follow-up Endoscopic: mean, 1.13, vs open:
ACCEPTED MANUSCRIPT
P=.32 P=.32 P=.76 P=.65
SC
Pain (VAS) (24wk)
RI PT
Carpal tunnel syndrome-Symptom severity score (24wk)
1.14 at 24wk follow-up Endoscopic: mean, 2.66, vs open: 2.50 at baseline Endoscopic: mean, 1.23, vs open: 1.28 at 12wk follow-up Endoscopic: mean, 1.21, vs open: 1.19 at 24w follow-up Endoscopic: mean, 1.33, vs open: 1.06 at baseline Endoscopic: mean, .40, vs open: .26 at 12wk follow-up Endoscopic: mean, .23, vs open: .19 at 24wk follow-up Endoscopic: mean, 6.92, vs open: 6.60 at baseline Endoscopic: mean, 5.13, vs open: 4.91 at 12wk follow-up Endoscopic: mean, 5.11, vs open: 4.71 at 24wk follow-up Endoscopic: mean, 3.64, vs open: 3.78 at baseline Endoscopic: mean, 3.06, vs open: 3.20 at 12wk follow-up Endoscopic: mean, 3.07, vs open: 3.11 at 24wk follow-up Endoscopic: mean, 4.50, vs open: 4.52 at baseline Endoscopic: mean, 4.87, vs open: 4.86 at 12wk follow-up Endoscopic: mean, 4.89, vs open: 4.90 at 24wk follow-up Endoscopic: mean, 15.20, vs open: 16.56 at baseline Endoscopic: mean, 15.33, vs open:
P=.29
M AN U
P=.44
Two-point discrimination test (24wk)
P=.71 P=.34
TE D
P=.24
EP
Semmes-Weinstein monofilament testing (24wk)
AC C
Abductor pollicis brevis strength (24wk)
Grip strength (24wk)
P=.38 P=.40 P=.79 P=.91 P=.91 P=.96 P=.55 P=.52
ACCEPTED MANUSCRIPT
14.09 at 12wk follow-up Endoscopic: mean, 15.79, vs open: 15.81 at 24wk follow-up
22
Group 1: Endoscopic carpal tunnel release (n=32)
Group 2: Regular open carpal tunnel release (n=36)
Night pain (4mo)
Numbness (4mo) Group 3: Mid-palmar mini incision (n=28)
M AN U
Stiffness (4mo)
NS, no P value given NS, no P value given NS, no P value given NS, no P value given P<.05
Wrist pain (4mo)
TE D
Weakness (4mo)
Zhang et al
65
Group 1: subneural reconstruction of the transverse carpal ligament (n=68)
AC C
EP
Grip strength (4mo) Pain (4mo)
Group 2: isolated open carpal tunnel release (n=92) Group 3: endoscopic carpal tunnel release
Boston carpal tunnel Questionnaire Symptom severity scale (24mo)
Group 1: 0/32, versus group 2: 0/36, versus group 3: 0/28 at 4mo follow up Group 1: 0/32, versus group 2: 0/36, versus group 3: 0/28 at 4mo follow up Group 1: 4/32, versus group 2: 2/36, versus group 3: 0/28 at 4mo follow up Group 1: 4/32, versus group 2: 0/36, versus group 3: 4/28 at 4mo follow up Group 1: 2/32, versus group 2: 4/36, versus group 3: 0/28, in favor of group 1 and group 3 versus group 2 at 4mo follow up No data given at 4mo follow-up No data given, but in favor of group 1 and group 3 versus group 2 at 4w follow-up No data given at 4mo follow-up
SC
Aslani et al
RI PT
P=.99
P<.05 P<.05
NS, no P value given
Group 1-2: P=.084 Group 1-3: P=.204
Group 1: mean ± SD, 39.5±6.1, vs group 2: 37.5±6.1, vs group 3: 38±6.1 at baseline
ACCEPTED MANUSCRIPT
Group 1: mean ± SD, 13.4±8.4, vs group 2: 14.2±9.5, vs group 3: 13.9±10.8 at 3mo follow-up
RI PT
Group 2-3: P=.457 Group 1-2: P=.206 Group 1-3: P=.674 Group 2-3: P=.739 Group 1-2: P=.264 Group 1-3: P=.777 Group 2-3: P=.773 Group 1-2: P=.336 Group 1-3: P=.381 Group 2-3: P=.520 Group 1-2: P=.267 Group 1-3: P=.423 Group 2-3: P=.329 Group 1-2: P=.114 Group 1-3: P=.612 Group 2-3: P=.082 Group 1-2: P=.001
Group 1: mean ± SD, 6.4±5.6, vs group 2: 6.2±5.2, vs group 3: 5.7±6.4 at 6mo follow-up
AC C
EP
TE D
M AN U
SC
(n=53)
Function status scale (24mo)
Group 1: mean ± SD, 5.1±5.7, vs group 2: 4.9±4.2, vs group 3: 4.8±4.1 at 12mo follow-up
Group 1: mean ± SD, 4.3±5.0, vs group 2: 4.4±5.5, vs group 3: 4.7±5.6 at 24mo follow-up
Group 1: mean ± SD, 27.3±6.6, vs group 2: 26.6±7.3, vs group 3: 28.6±5.5 at baseline
Group 1: mean ± SD, 5.1±3.9, vs group 2: 9.3±7.5, vs group 3:
ACCEPTED MANUSCRIPT
RI PT
6.8±5.2 at 3mo follow-up
Group 1: mean ± SD, 4.5±3.7, vs group 2: 6.9±6.6, vs group 3: 6.2±6.3 at 6mo follow-up
TE D
M AN U
SC
Group 1-3: P=.030 Group 2-3: P=.045 Group 1-2: P=.001 Group 1-3: P=.026 Group 2-3: P=.231 Group 1-2: P=.003 Group 1-3: P=.031 Group 2-3: P=.452 Group 1-2: P=.015 Group 1-3: P=.001 Group 2-3: P=.248 Group 1-2: P=.905 Group 1-3: P=.490 Group 2-3: P=.273 Group 1-2: P=.001 Group 1-3: P=.001 Group 2-3: P=.169
AC C
EP
Cylindrical grip strength
Group 1: mean ± SD, 3.5±2.9, vs group 2: 6.5±5.8, vs group 3: 6.8±5.1 at 12mo follow-up
Group 1: mean ± SD, 3.3±3.6, vs group 2: 6.8±5.2, vs group 3: 6.2±6.5 at 24mo follow-up
Group 1: mean ± SD, 71.8±17.5, vs group 2: 73±17.5, vs group 3: 74.6±15.8 at baseline
Group 1: mean ± SD, 74.7±14.5, vs group 2: 84.4±13.7, vs group 3: 87.2±13.5 at 3mo follow-up
ACCEPTED MANUSCRIPT
RI PT
Group 1: mean ± SD, 87.9±12.1, vs group 2: 87.4±12.8, vs group 3: 89.9±12.2 at 6mo follow-up
Group 1: mean ± SD, 95.7±14.6, vs group 2: 88.2±10.9, vs group 3: 87.4±14.1 at 12mo follow-up
M AN U
SC
Group 1-2: P=.001 Group 1-3: P=.009 Group 2-3: P=.367 Group 1-2: P=.015 Group 1-3: P=.032 Group 2-3: P=.451 Group 1-2: P=.002 Group 1-3: P=.001 Group 2-3: P=.347 Group 1-2: P=.352 Group 1-3: P=.477 Group 2-3: P=.087 Group 1-2: P=.255 Group 1-3: P=.374 Group 2-3: P=.786 Group 1-2: P=.427 Group 1-3: P=.126
AC C
EP
TE D
Lateral grip strength (24mo)
Group 1: mean ± SD, 96.1±18.2, vs group 2: 87±15.7, vs group 3: 86.9±17.6 at 24mo follow-up
Group 1: mean ± SD, 76.8±13.4, vs group 2: 78±17.6, vs group 3: 72.3±16.3 at baseline
Group 1: mean ± SD, 82.8±18.1, vs group 2: 85.7±19.5, vs group 3: 84.9±15 at 3mo follow-up
Group 1: mean ± SD, 86.7±12.8, vs group 2: 84.9±18.4, vs group 3: 86.5±13.6 at 6mo follow-up
ACCEPTED MANUSCRIPT
RI PT
Group 1: mean ± SD, 92.2±16.5, vs group 2: 89.7±17.4, vs group 3: 88.5±10.9 at 12mo follow-up
Group 1: mean ± SD, 97.6±12.4, vs group 2: 88.4±18.3, vs group 3: 92.5±12.5 at 24mo follow-up
M AN U
SC
Group 2-3: P=.352 Group 1-2: P=.250 Group 1-3: P=.293 Group 2-3: P=.224 Group 1-2: P=.754 Group 1-3: P=.329 Group 2-3: P=.128 Group 1-2: P=.266 Group 1-3: P=.753 Group 2-3: P=.182 Group 1-2: P=.525 Group 1-3: P=.094 Group 2-3: P=.007 Group 1-2: P=.004 Group 1-3: P=.008 Group 2-3: P=.269 Group 1-2: P=.012
AC C
EP
TE D
Pinch grip strength (24mo)
Group 1: mean ± SD, 75.8±16.3, vs group 2: 73±23.1, vs group 3: 76.3±15.3 at baseline
Group 1: mean ± SD, 77.4±16.4, vs group 2: 75.5±18.1, vs group 3: 78.3±12.9 at 3mo follow-up
Group 1: mean ± SD, 95±16.4, vs group 2: 82.3±22.2, vs group 3: 80.7±16.5 at 6mo follow-up
Group 1: mean ± SD, 96.5±17.3, vs group 2: 80.8±17.7, vs group 3:
ACCEPTED MANUSCRIPT
RI PT
82.5±12.4 at 12mo follow-up
Kang et al
24
Endoscopic carpal tunnel release (n=52)
AC C
EP
TE D Mini-incision carpal tunnel release (n=52)
Boston carpal tunnel Questionnaire Symptom severity scale (3mo)
Group 1: mean ± SD, 96.1±17.3, vs group 2: 81.5±17.8, vs group 3: 84.3±16.1 at 24mo follow-up
SC
M AN U
Michigan Hand Outcome (24mo)
Group 1-3: P=.032 Group 2-3: P=.531 Group 1-2: P=.006 Group 1-3: P=.025 Group 2-3: P=.392 Group 1-2: P=.478 Group 1-3: P=.216 Group 2-3: P=.321 Group 1-2: P=.002 Group 1-3: P=.012 Group 2-3: P=.006 Group 1-2: P=.001 Group 1-3: P=.001 Group 2-3: P=.001
No P value given
Group 1: mean ± SD, 45.2±14.4, vs group 2: 48.5±15.9, vs group 3: 43.2±12.1 at baseline
Group 1: mean ± SD, 89.5±12.6, vs group 2: 76.3±21.6, vs group 3: 81.5±14.8 at 12mo follow-up
Group 1: mean ± SD, 91.2±7.2, vs group 2 84.4±8.4, vs group 3: 86.2±7.6 at 24mo follow-up
Endoscopic: mean, 3.3 (95% CI, 3.1 to 3.5), vs mini-incision: 3.3 (95% CI, 3.1 to 3.5) at baseline
ACCEPTED MANUSCRIPT
Functional status scale (3mo)
P=.774 No P value given
P=.832 No P value given
M AN U
Disabilities of the Arm Shoulder and Hand (3mo)
SC
No P value given
No P value given
Group 2: Open carpal tunnel release (classic incision) (n=30)
Pain (VAS)
EP
Group 1: Endoscopic carpal tunnel release (n=30)
Group 3: Open carpal tunnel release (short incision) (n=30)
AC C
69
TE D
P=.978
Larsen et al
Paraesthesia (VAS)
Endoscopic: mean, 1.5 (95% CI, 1.4 to 1.6), vs mini-incision: 1.4 (95% CI, 1.4 to 1.6) at 3mo follow-up MD at 3mo: no exact data given Endoscopic: mean, 2.8 (95% CI, 2.6 to 3.1), vs mini-incision: 3.0 (95% CI, 2.6 to 3.0) at baseline Endoscopic: mean, 1.5 (95% CI, 1.4 to 1.6), vs mini-incision: 1.7 (95% CI, 1.3 to 1.5) at 3mo follow-up MD at 3mo: no exact data given Endoscopic: mean, 48 (95% CI, 44 to 53), vs mini-incision: 48 (95% CI, 43 to 52) at baseline Endoscopic: mean, 11 (95% CI, 9 to 14), vs mini-incision: 11 (95% CI, 8 to 14) at 3mo follow-up MD at 3mo: no exact data given
RI PT
No P value given
No P value given NS, no P value given NS, no P value given No P value given NS, no P value given NS, no P value
No exact data given at baseline No exact data given at 12w followup No exact data given at 24w followup No exact data given at baseline No exact data given at 12w followup No exact data given at 24w followup
ACCEPTED MANUSCRIPT
74
Heidarian et 75 al
Tarallo et al
82
Carpal tunnel release using a Knifelight (n=39)
Open carpal tunnel release (n=43)
Quick Disabilities of the Arm Shoulder and Hand (10y)
Knifelight surgery (n=29)
Standard open carpal tunnel release (n=30)
Pain (VAS) (3wk)
Minimal access
Standard open carpal
Boston carpal tunnel
AC C
Elsharif et al
EP
TE D
RI PT
M AN U
Grip strength
No exact data given, but significant in favor of group 1 versus group 2 and group 3 at 3w follow- up No exact data given at 12w followup No exact data given at 24w followup
SC
Range of motion
given Significant, no P value given NS, no P value given NS, no P value given Significant, no P value given Significant, no P value given Significant, no P value given NS, no P value given
No exact data given, but significant in favor of group 1 versus group 2 and group 3 at 3w follow- up No exact data given, but significant in favor of group 1 and group 2 versus group 3 at 6w follow- up No exact data given, but significant in favor of group1 and group 2 versus group 3 at 12w follow- up No exact data given at 24w followup
P=.0024
Knifelight: mean ± SD, 13.22±13.62, vs open: 34.10 ± 23.27 at 10y follow-up
P=.24
Knifelight: mean ± SD (95% CI), 1.38±1.08 (1 to 1.8), vs standard: 1.80±1.58 (1.2 to 2.4) at 3wk follow-up
ACCEPTED MANUSCRIPT
tunnel release (n=60)
Questionnaire Symptom severity scale (12mo)
NS, no P value given P<.001
TE D
Standard CTD (n=42)
Scar pain scores
EP
Nerve-preserving CTD (n=42)
AC C
Siegmeth and Hopkinson83 Woolley
PEM score, second part (i.e., outcome, range 1-7)
Minimal access: mean ± SD, 1.1±.1 vs standard CTR: 1.6±.4 at 12mo follow-up
NS, no P value given P<.001
Minimal access: mean ± SD, 3.7±.3 vs standard CTR: 3.6±.4 at baseline
P<.001
Minimal access: mean ± SD, 1.1±.1 vs standard CTR: 1.5±.2 at 12mo follow-up
P=.59
3mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 6mo after surgery: no differences between nervepreserving CTS and standard CTD (no data given) 3mo after surgery: no differences between nerve-preserving CTS and standard CTD (no data given) 6mo after surgery: no differences between nerve- preserving CTS and standard CTD (no data given)
M AN U
Functional status scale (12mo)
Minimal access: mean ± SD, 1.4±.3 vs standard CTR: 2.7±.6 at 6mo follow-up
SC
P<.001
Minimal access: mean ± SD, 3.9±.4 vs standard CTR: 3.8±.5 at baseline
RI PT
carpal tunnel release (n=60)
P=.38
P=.43
P=.13
Minimal access: mean ± SD, 1.4±.4 vs standard CTR: 2.3±.6 at 6mo follow-up
ACCEPTED MANUSCRIPT
Open carpal tunnel release with preservation of the parietal layer of the ulnar bursa beneath the flexor retinaculum (n=53)
Open carpal tunnel release with division of the parietal layer of the ulnar bursa beneath the flexor retinaculum (n=58)
Grip strength (9wk)
Preservation of ulnar bursa: mean ± SD, 4.1±.32 at baseline to mean (95% CI),13.2 (10.7 to 15.7) at 9wk follow-up vs division of ulnar bursa:
P=.661
RI PT
Forward et 84 al
20.0±1.7 at baseline to 14.7 (11.3 to 18.2) at 9 wk follow-up
P=.990
Preservation of ulnar bursa: mean ± SD, 54±0.3 at baseline to mean (95% CI), 26 (21 to 32) at 9 wk follow-up vs division
Crnković et 94 al
Decompression of the median nerve by open carpal tunnel release without perineural corticosteroid injection (n=20)
Open carpal tunnel release followed by longitudinal epineurotomy (n=25)
Standard open carpal tunnel release (n=25)
Disappearance of symptoms (%; 90d)
Grip strength (kg) (180d)
Pain (VAS) (180d)
of ulnar bursa: 57±0.3 at baseline to 25 (20 to 30) at 9wk follow-up
No P value given
Treatment group: 77.5% 7d after treatment and 97.5% 90d after treatment vs controls: 75% 7d after treatment and 95% 90d after treatment #
NS, no P value given NS, no P value given NS, no P value given P=.271
CTR with epineurtomy: mean, 21.5, vs standard CTR: 23 at baseline
TE D
Decompression of the median nerve by open carpal tunnel release with perineural injection of 1mL betamethasone immediately after decompression (n=20)
EP
85
AC C
Stepic et al
M AN U
SC
Patient evaluation Measure score (9wk)
CTR with epineurtomy: mean, 21, vs standard CTR: 19.5 at 90d follow-up CTR with epineurtomy: mean, 22, vs standard CTR: 24 at 180d follow-up Difference between groups (95%
ACCEPTED MANUSCRIPT
Group 2: Standard open carpal tunnel release (n=15 hands)
Levine's symptom Severity score (3mo)
P=0.38
Levine's Functional score (3mo)
P=0.9693
P=0.474
Group 1: mean ± SD, 52±6.49, vs group 2: 50.3 ± 6.11 at 1mo follow-up
P=0.004
Group 1: mean ± SD, 62.67±5.62, vs group 2: 55.67 ± 6.51 at 3mo follow-up
Pinch strength (pounds) (3mo)
P=0.79
2-point discrimination test (3mo)
P=0.28
Group 1: mean ± SD, 13.6±1.84, vs group 2: 12.47 ± 1.55 at 3mo follow-up Group 1: mean, 3.28, vs group 2: 3.04 at baseline
TE D EP Group 1: Carpal tunnel release with short wrist transverse
Group 2: Carpal tunnel release with limited open technique (n=42)
Group 1: mean ± SD, 1.17±0.17, vs group 2: 1.23 ± 1.95 at 3mo follow-up Group 1: mean, 2.946, vs group 2: 2.956 at baseline Group 1: mean ± SD, 1.28±0.31, vs group 2: 1.45 ± 0.5 at 3mo follow-up
AC C 93
Group 1: mean, 3.2, vs group 2: 2.87 at baseline
P=0.29
Grip strength (pounds) (3mo)
Cho et al
P=0.3186
SC
Group 1: Limited open carpal tunnel release using direct vision plus tunneling technique (n=15 hands)
M AN U
Suppaphol et 92 al
RI PT
P=.017
CI): .62 (-.50 to 1.73) in favour of standard CTR at 90d follow-up Difference between groups (95% CI): 1.38 (.26 to 2.49) in favour of standard CTR at 180d follow-up
Brigham and Women's carpal tunnel Questionnaire
P=0.63
Group 1: mean ± SD, 2.75±0.62, vs group 2: 2.63 ± 0.69 at 3mo follow-up
ACCEPTED MANUSCRIPT
open technique (n=42)
Symptom severity scale (2y)
P=.56
P=.38 Functional status scale (2y)
P=.44
SC
P=.58
RI PT
P=.36
Group 1: mean, 3.80 vs group 2: 3.78 at baseline Group 1: mean, 1.62 vs group 2: 1.64 at 1y follow-up Group 1: mean, 1.48 vs group 2: 1.50 at 2y follow-up Group 1: mean, 3.83 vs group 2: 3.82 at baseline Group 1: mean, 1.65 vs group 2: 1.68 at 1y follow-up Group 1: mean, 1.53 vs group 2: 1.56 at 2y follow-up Group 1 (%): 26/39 (67%) vs group 2: 29/40 (72%) at 3mo follow-up Group 1 (%): 13/39 (33%) vs group 2: 14/40 (35%) at 6mo follow-up Group 1 (%): 2/39 (5%) vs group 2: 5/40 (2%) at 1y follow-up Group 1 (%): 1/39 (3%) vs group 2: 1/40 (3%) at 2y follow-up
M AN U
P=.39 Scar discomfort (2y)
P=.32 P=.24
Transverse carpal ligament releasing with distal forearm fascia releasing (n=80)
Transverse carpal ligament releasing (n=79)
Pain (VAS) (24mo)
EP
96
AC C
Acar et al
TE D
P=.38
Hamed et al
98
Open carpal tunnel decompression using a double-incision
Open carpal tunnel decompression using the standard single-
P=.58
P=.120 P=.120
Night-time paraesthesia, positive (24mo)
P=.120
Pillar pain (6mo)
P=0.04
P=.107
TCL+DFFR: mean ± SD, 6.52±2.70, vs TCL, 7.13±2.23 at baseline TCL+DFFR: mean ± SD, 1.26±2.38, vs TCL, 1.00±2.09 at 24mo follow-up TCL+DFFR: 100%, vs TCL 92.2% at baseline TCL+DFFR: 100%, vs TCL 0% at 24mo follow-up Number of wrists with pillar pain: double incision: 4/19 vs single incision:12/21 at 3mo follow-up
ACCEPTED MANUSCRIPT
incision technique (n=21) Grip strength (6mo)
P=0.03
Number of wrists with pillar pain: double incision: 1/19 vs single incision: 8/21 at 6mo follow-up
P=1.0
Double incision: mean ± SD, 46±10, vs single incision: 46±8 at baseline Double incision: mean ± SD, 65±12, vs single incision: 61±10 at 3mo follow-up
P=0.25
Double incision: mean ± SD, 70±16, vs single incision: 65±16 at 6mo follow-up
Brigham and Women's carpal tunnel Questionnaire Symptom severity scale (6mo+)
TE D
Standard open carpal tunnel release (n=16)
EP
Two-incision carpal tunnel release (n=14)
Functional status scale (6mo+)
AC C
Castillo and 95 Yao
M AN U
SC
P=0.45
RI PT
technique (n=19)
Disabilities of the Arm
P=0.58
P=0.61
P=0.09
P=0.72
P=0.69
P=0.35
P=0.61
Two-incision: mean ± SD, 2.91±.59, vs standard CTR: 2.84±.77 at baseline Two-incision: mean ± SD, 1.89±.77, vs standard CTR: 2.27±1.58 at 6w follow-up Two-incision: mean ± SD, 1.33±.53, vs standard CTR: 1.33±.36 at 6mo+ follow-up Two-incision: mean ± SD, 2.54±.75, vs standard CTR: 2.39±.97 at baseline Two-incision: mean ± SD, 2.10±1.06, vs standard CTR: 2.08±.79 at 6wk follow-up Two-incision: mean ± SD, 1.60±.87, vs standard CTR: 1.57±.88 at 6mo+ follow-up Two-incision: mean ± SD,
ACCEPTED MANUSCRIPT
Shoulder and Hand Questionnaire (6mo+)
P=0.11
SC
P=0.92
P=0.33
Two-incision: mean ± SD, .0±0, vs standard CTR: .13±.50 at 6mo+ follow-up
P=0.35
Two-incision: mean ± SD, 1.18±2.44, vs standard CTR: .25±.87 at 6wk follow-up Two-incision: mean ± SD, .0±0, vs standard CTR: .56±1.55 at 6mo+ follow-up
M AN U
Scar tenderness (6mo+)
RI PT
P=0.83
Radial pillar pain (6mo+)
TE D
P=0.65
AC C
EP
Ulnar pillar pain (6mo+)
Grip strength (lb) (6mo+)
35.80±14.23, vs standard CTR: 41.96±24.10 at baseline Two-incision: mean ± SD, 30.48±25.49, vs standard CTR: 26.68±18.83 at 6wk follow-up Two-incision: mean ± SD, 13.50±22.46, vs standard CTR: 13.22±20.63 at 6mo+ follow-up Two-incision: mean ± SD, .45±.93, vs standard CTR: .42±.90 at 6wk follow-up
P=0.55
Two-incision: mean ± SD, .36±.67, vs standard CTR: .83±1.40 at 6wk follow-up
P=0.49
Two-incision: mean ± SD, .0±0, vs standard CTR: .94±2.05 at 6mo+ follow-up
P=0.45
Two-incision: mean ± SD, 44.53±23.13, vs standard CTR: 36.16±21.20 at baseline Two-incision: mean ± SD, 26.18±13.12, vs standard CTR: 37.46±21.84 at 6wk follow-up Two-incision: mean ± SD, 43.60±14.15, vs standard
P=0.28
P=1.00
ACCEPTED MANUSCRIPT
CTR: 42.81±22.15 at 6mo+ follow-up P=0.34
P=0.55
TE D
M AN U
Change in SemmesWeinstein monofilament scores Thumb (6mo+)
SC
P=0.07
AC C
EP
Second finger (6mo+)
Third finger (6mo+)
Vanni et al
99
Double tunnels
Standard open
Boston carpal tunnel
Two-incision: mean ± SD, 17.85±12.68, vs standard CTR: 12.00±5.83 at baseline Two-incision: mean ± SD, 13.64±4.27, vs standard CTR: 12.08±5.23 at 6wk follow-up Two-incision: mean ± SD, 16.60±3.27, vs standard CTR: 12.25±6.04 at 6mo+ follow-up
RI PT
Pinch strength (lb) (6mo+)
P=0.75
Two-incision: mean ± SD, -.18±.60, vs standard CTR: -.17±.83 at 6wk follow-up
P=0.53
Two-incision: mean ± SD, -.20±.63, vs standard CTR: -.38±.72 at 6mo+ follow-up
P=0.03
Two-incision: mean ± SD, -.18±.40, vs standard CTR: -.67±.49 at 6wk follow-up
P=0.09
Two-incision: mean ± SD, -.10±.32, vs standard CTR: -.56±.51 at 6mo+ follow-up
P=0.22
Two-incision: mean ± SD, -.36±.50, vs standard CTR: -.67±.49 at 6wk follow-up
P=0.04
Two-incision: mean ± SD, .0±.50, vs standard CTR: -.69±.60 at 6mo+ follow-up
No P value
Double tunnels: mean ± SD, 2.1±1.1
ACCEPTED MANUSCRIPT
decompression of the median nerve (n=110)
Questionnaire (12mo)
given
vs standard CTR: 8.3±3.8 at 3mo follow-up
No P value given
Double tunnels: mean ± SD, .8±0.1 vs standard CTR: 8.1±1.2 at 6mo follow up
P<.05
P<.05
Double tunnels: mean ± SD, .1±.03 vs standard CTR: 1.9±.9 at 12mo follow up Double tunnels: mean ± SD, 2.1±.5 vs standard CTR: 4.9±.5 at 12mo follow up
Pain (VAS) (3mo)
P=.5
Grip strength (3mo)
P=.5
Pinch grip (3mo)
P=.6
Levine-Katz questionnaire Symptoms (3 mo, 7y)
P=.6
TE D
Carpal tunnel decompression using the standard limited palmar open incision (n=100)
EP
Carpal tunnel decompression using the Biomet TM Indiana Tome (mini open technique; n=100)
AC C
Cresswell et 97 al
M AN U
SC
Pain (VAS) (12mo)
RI PT
technique (n=110)
Levine-Katz questionnaire Function (3mo, 7y)
P<.05 P=.7
P=.2
TM Indiana Tome: 1.9 (mean) at 3mo vs open incision: 2.0 at 3mo follow-up TM Indiana Tome: 96% (mean) at 3mo vs open incision: 94% at 3mo follow-up TM Indiana Tome: 93% (mean) at 3mo vs open incision: 89% at 3mo follow-up TM Indiana Tome: from 17.8 (mean) preoperative to 18.5 at 3mo vs open incision: from 19.3 preoperative to 17.1 at 3mo follow-up TM Indiana Tome*: 16.0 (mean) vs open incision: 13 at 7y follow-up TM Indiana Tome: from 33.9 (mean) preoperative to18.5 at 3mo vs open incision: from 34.5 preoperative to 19.8 at 3mo follow-up TM Indiana Tome: 12 (mean) vs open incision: 10 at 7y follow-up
ACCEPTED MANUSCRIPT
100
Carpal tunnel release, incision distal to the flexor crease (n=45)
Carpal tunnel release, incision proximal to the flexor crease (n=45)
Boston carpal tunnel Questionnaire Symptom severity scale (1mo)
NS, no P value given
mean ± SD, 3.27±.72 vs incision proximal to the flexor crease: 3.38±.76 at baseline Incision distal to the flexor crease:
mean ± SD, 2.41±.75 vs incision proximal to the flexor crease:
SC
NS, no P value given
Incision distal to the flexor crease:
RI PT
Uçar et al
M AN U
NS, no P value given
AC C
EP
TE D
Function status scale (1mo)
Xu et al
101
Coronal Z-type lengthening of transverse carpal
Standard open approach surgery (n=28)
Grip strength (kg) (12mo)
NS, no P value given NS, no P value given NS, no P value given
2.65±.76 at 1mo follow-up Incision distal to the flexor crease:
mean ± SD, 2.42±.75 at (mean ± SD) 30.4 ± 15.0 vs incision proximal to the flexor crease: 2.16±.68 at (mean ± SD) 31.0±15.3 at 1mo follow-up Incision distal to the flexor crease:
mean ± SD, 3.10±.70 vs incision proximal to the flexor crease: 3.13±.76 at baseline Incision distal to the flexor crease: mean ± SD, 2.14±.69 vs incision proximal to the flexor crease: 2.19±.75 at 1mo follow-up Incision distal to the flexor crease: mean ± SD, 2.66±.74 at (mean ± SD) 30.4 ± 15.0 mo vs incision proximal to the flexor crease: 2.21±.73 at (mean ± SD) 31.0±15.3 mo
No P value given
Z-type lengthening: mean ± SD, 7±1.1, vs standard open approach: 4.5±1.5 at baseline
ACCEPTED MANUSCRIPT
Z-type lengthening: mean ± SD, 20.8±1.4, vs standard open approach: 19.2±1.2 at 3mo follow-up
P=.01
Z-type lengthening: mean ± SD, 39.6±7.5, vs standard open approach: 21.4±6.2 at 6mo follow-up Z-type lengthening: mean ± SD, 38.4±6.4, vs standard open approach: 22.6±4.5 at 12mo follow-up
M AN U
SC
P=.01
RI PT
P=.05
ligament (n=30)
Post-operative treatment
Pain (VAS) (6mo)
TE D
Soft bulky dressing after limited open carpal tunnel release (n=14)
2-point discrimination test radial side of the index finger (6mo)
EP
Splint after limited open carpal tunnel release for 1w (n=16)
AC C
Shalimar et 124 al
Ulnar side of the index finger (6mo)
NS, no P value given NS, no P value given NS, no P value given
Splint: mean ± SD, 4.7±2.0, vs no splint: 5.6±2.3 at baseline Splint: mean ± SD, 1.3±1.8, vs no splint: 1.4±1.8 at 2mo Splint: mean ± SD, .1±.3, vs no splint: .4±1.3 at 6mo
NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P
Splint: mean ± SD, 7.0±3.7, vs no splint: 6.4±2.0 at baseline Splint: mean ± SD, 5.0±1.0, vs no splint: 5.6±1.4 at 2mo Splint: mean ± SD, 4.3±1.0, vs no splint: 4.7±.7 at 6mo Splint: mean ± SD, 5.8±1.6, vs no splint: 6.2±1.6 at baseline Splint: mean ± SD, 4.8±.5, vs no splint: 5.6±1.3 at 2mo Splint: mean ± SD, 4.3±1.0, vs no
ACCEPTED MANUSCRIPT
M AN U
SC
Grip strength (6mo)
splint: 5.3±2.1 at 6mo Splint: mean ± SD, 4.9±2.0, vs no splint: 4.5±1.5 at baseline Splint: mean ± SD, 4.3±1.5, vs no splint: 5.1±1.4 at 2mo Splint: mean ± SD, 6.0±2.4, vs no splint: 6.2±1.9 at 6mo Splint: mean ± SD, 18.4±8.2, vs no splint: 18.9±4.5 at baseline Splint: mean ± SD, 16.3±6.9, vs no splint: 18.5±4.9 at 2mo Splint: mean ± SD, 21.4±8.5, vs no splint: 22.9±5.6 at 6mo Splint: mean ± SD, 3.9±.7, vs no splint: 3.7±1.1 at baseline Splint: mean ± SD, 4.1±.4, vs no splint: 4.1±.4 at 2mo Splint: mean ± SD, 4.5±1.1, vs no splint: 4.4±1.1 at 6mo
RI PT
Pinch strength (6mo)
value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given
TE D
Power grade abductor pollicis brevis (6mo)
AC C
EP
Boston Questionnaire Symptom Severity scale (6mo)
Functional status scale (6mo)
Scar pain (6mo)
NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given NS, no P value given P=.53
Splint: mean ± SD, 2.6±.7, vs no splint: 2.5±.5 at baseline Splint: mean ± SD, 1.2±.2, vs no splint: 1.4±.3 at 2mo Splint: mean ± SD, 1.0±.0, vs no splint: 1.1±.3 at 6mo Splint: mean ± SD, 2.9±.5, vs no splint: 2.8±.8 at baseline Splint: mean ± SD, 1.5±.5, vs no splint: 1.4±.5 at 2mo Splint: mean ± SD, 1.0±.1, vs no splint: 1.0±.4 at 6mo Splint: 4/16, versus no splint: 5/14 at 2mo
ACCEPTED MANUSCRIPT
P=.277
Splint: 0/16, versus no splint: 0/14 at 6mo Splint: 1/16, versus no splint: 1/14 at 2mo Splint: 0/16, versus no splint: 1/14 at 6mo
RI PT
Pillar pain (6mo)
NS, no P value given P=.992
AC C
EP
TE D
M AN U
SC
Abbreviations: NS not significant; RCT, Randomised Controlled Trial; RR relative risk; OR odds ratio; MD mean difference; WMD weighted mean difference; y, years; wk, weeks; d, days; CI, confidence interval; SD, standard deviation; vs, versus, VAS Visual Analogue Scale; kg, kilogram; n, number; mg, milligram’; CTD, carpal tunnel decompression; PEM, Patient Evaluation Measure; NPRS Numeric Pain Rating Scale; BQ Boston Questionnaire. * in favor of. # groups not compared between groups (ie, only compared within groups).
ACCEPTED MANUSCRIPT
Appendix 3. Additional RCTs: CTS Control/comparison
Outcome measures
Results –
Results by Outcome
(total FU time)
Statistical
Measure
Clinical score (>6mo after surgery)
No P value given P<.001
Timing of surgery Chandra et 37 al
Early surgery : <1w after diagnosis (n=51)
Delayed surgery: 6mo after diagnosis (n=49)
Various surgical techniques
Levine Questionnaire Symptom severity scale (60d)
TE D
Release of the transverse carpal ligament without corticosteroid irrigation of the median nerve(n=10)
Functional status scale (60d)
AC C
Release of the transverse carpal ligament with corticosteroid irrigation of the median nerve before skin closure (n=10)
EP
86
Padua et al
P<.001
M AN U
Return to activity, percentage complete return (>6mo after surgery)
RI PT
Treatment
SC
Author
P=.005
Early: mean ± SD, 20.06±2.12, vs delayed: 21.33±1.55 at baseline Early: mean ± SD, 8.11±3.85, vs delayed: 18.19±4.32 at >6mo follow-up after surgery Early: 100%, vs delayed 11% at >6mo follow-up
Steroid treatment group*: from mean ±SD, (95% CI), 44.8±6.0 (41.0-48.6) at baseline to 11.8±1.3 (10.8-12.7) at 60d vs controls: from
NS, no P value given
41.8±5.4 (37.6-45.9) at baseline to 19.4±2.1 (17.8-21.1) at 60d Steroid treatment group: from mean ± SD, 28.8±9.2 (22.334.1) at baseline to 9.00±1.6 (7.9-10.1) at 60d vs controls: from 26.9±9.2 (19.8-34.0) at baseline to 15.4±1.3 (14.4-16.5) at 60d
Abbreviations: NS not significant; RCT, Randomised Controlled Trial; n, number; d, days; wk, weeks; SD, standard deviation; vs, versus; VAS, Visual Analogue Scale. * in favor of. # between groups not compared (i.e. only within groups); CTS, carpal tunnel syndrome.