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Is radiofrequency treatment effective for shoulder impingement syndrome? A prospective randomized controlled study
J Shoulder Elbow Surg (2013) 22, 1488-1494
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Is radiofrequency treatment effective for shoulder impingement syndrome? A prospective randomized controlled study Yi Lu, MD, PhD, Qiang Zhang, MD, Yiming Zhu, MD, PhD, Chunyan Jiang, MD* Shoulder and Elbow Service, Beijing Ji Shui Tan Hospital, School of Medicine, Peking University, Beijing, China Background: To determine whether radiofrequency based plasma microtenotomy has a positive effective in the treatment of shoulder impingement syndrome with cuff tendinosis. Materials and methods: Eighty patients with impingement syndrome and cuff tendinosis that were treated arthroscopically were enrolled in the study. The patients were randomly assigned to receive either arthroscopic subacromial decompression (ASD) alone (ASD group, n ¼ 40) or arthroscopic subacromial decompression combined with radiofrequency (RF) based plasma microtenotomy (RF group, n ¼ 40). Clinical outcome data including VAS pain score, shoulder range of motion (ROM), ASES, UCLA, ConstantMurley, and SST score were recorded preoperatively and at 3 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. Results: Sixty-five out of eighty patients (81.3%) were available for the final follow-up at 1 year postoperation. There were 32 patients in the ASD group and 33 in the RF group. Both treatment groups showed significantly (P ¼ .031 in the ASD group vs P ¼ .017 in the RF group) reduced pain 3 weeks postoperatively. Both treatment groups showed significantly improved functional scores 3 months postoperatively. Both treatment groups showed significantly improved flexion elevation (FE) and external rotation (ER) 1 year postoperatively and internal rotation (IR) 6 months postoperatively. No significant difference between the 2 groups was found in any of the outcome measurements at any time point postoperatively. Conclusion: Arthroscopic subacromial decompression is a reliable treatment for refractory impingement syndrome. The additional radiofrequency based plasma microtenotomy did not show any significant positive effects regarding pain relief, ROM, or functional recovery. Level of evidence: Level II, Randomized Controlled Trial, Treatment Study. Ó 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Arthroscopic subacromial decompression; bipolar radiofrequency; tendon debridement; shoulder surgery; topaz; microtenotomy
IRB Approval no. 2009-156: Beijing Jishuitan Hospital. *Reprint requests: Chunyan Jiang, MD, Shoulder and Elbow Service, Beijing Ji Shui Tan Hospital, School of Medicine, Peking University, No. 31 Xinjiekoudongie, 100035 Beijing, China. E-mail address: [email protected] (C. Jiang).
Shoulder impingement syndrome is a clinical entity characterized by shoulder pain, weakness, and difficulties in daily activities often associated with pathology in the subacromial bursa and lesions of the supraspinatus tendon. Neer’s description of this entity in 197222 greatly enhanced our understanding of the pathophysiology and the treatment
1058-2746/$ - see front matter Ó 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2013.06.006
Radiofrequency treatment for shoulder impingement syndrome
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of this disease. Subacromial decompression, which includes removing the undersurface of the anterior aspect of the acromion, resecting the coracoacromial ligament, subacromial bursectomy, and debridement, had been accepted as the ‘‘golden standard’’ of treatment.23 Ellman et al8 observed an 88% success rate at 1-3 years postoperatively, using Neer’s technique for arthroscopic subacromial decompression in patients with advanced stage II impingement without a rotator cuff tear. De Baere et al6 also reported a significant postoperative improvement in pain and range of motion (ROM). The mechanism of the bipolar radiofrequency-(RF) based device can create a chemical process that excites the water molecules in an electrolyte solution and then generates excited radicals, breaks molecular bonds and excises soft tissue at relatively low temperatures (typically 40-70 C).29,30,35 This device is designed to ablate small segments of the tendon (a process called microtenotomy) and leave the remainder intact, as well as stimulate the release of angiogenic growth factors that promote tendon healing.12,18 Previous studies reported that RF-based plasma microtenotomy showed success in treating tendonitis of the lateral epicondyle, plantar fascia, patellar tendon and Achilles tendon.1,12,20,31-33 There have been biomechanical and clinical studies on the effects of radiofrequency treatment on supraspinatus tendonitis, but the conclusions of these studies remain controversial.3,28,34 The purpose of this study was to determine whether RF-based plasma microtenotomy has a positive effect in the treatment of shoulder impingement syndrome.
criteria and agreed to participate were enrolled in the study. The mean duration from the onset of the symptoms to surgery was 15.2 months (range, 6 months to 2 years). All patients had a positive Neer’s sign (the patient felt pain when the arm was brought into full elevation in the scapular plane with the arm internally rotated by the examiner), Hawkins’ sign (the patient felt pain when the arm was forcibly internally rotated with the shoulder placed in 90 of forward flexion and the elbow was bent 90 by the examiner) and Jobe’s test (pain or weakness presented when the patient resists a downward force applied by the examiner to the wrist with the arm at 90 of elevation in the scapular plane with an internal rotation with the thumb pointing down). All patients presented with supraspinatus tendinosis on the preoperative MRI but showed no evidence of any discontinuation of the rotator cuff tendon. None of the patients responded to 8 weeks of physical therapy (including rest, ice, activity modification, nonsteroidal antiinflammatory drug administration, ROM exercises, and strengthening) first and (if the treatment did not result in a positive outcome) a subacromial corticosteroid injection (0.5 ml of Diprospan, 1 ml of Ropivacaine, and 1% Lidocaine with 2.5 ml of saline injected just below the anteroinferior corner of the acromion13) combined with an additional 12 weeks of therapy. All patients then underwent arthroscopic subacromial decompression. Patients were randomly assigned to receive either arthroscopic subacromial decompression (ASD) alone (ASD group, n ¼ 40) or arthroscopic subacromial decompression combined with RF-based plasma microtenotomy (RF group, n ¼ 40). Randomization was accomplished through the use of a random numbers list generated by software and kept by the operating room nurse. Prior to the surgery, the circulating nurse reviewed the random numbers list. Patients who had been assigned an odd number were subsequently treated with only acromioplasty, and those who had been assigned an even number were managed with both acromioplasty and RF treatment.
Methods
Preoperative evaluation
Study design
All of the preoperative and follow-up evaluations were performed by the same independent observer who was involved in neither the outpatient care nor the surgery. The active range of shoulder motion was measured with a standard goniometer. The forward elevation (FE) was measured on the scapular plane under the patients’ own power while sitting. The external rotation (ER) at the side was measured using the angle between the long axis of the forearm when externally rotating and the same axis when the forearm was at the neutral position with the elbow flexed to 90 . The internal rotation (IR) was measured as the tip of the thumb to the highest level of the back. The American Shoulder & Elbow Surgeon’s (ASES) score,21 Simple Shoulder Test (SST) questionnaire,19 University of California Los Angeles (UCLA) score,7 and Constant-Murley score were recorded to evaluate shoulder function.4,5,11,16 The severity of pain was graded on a 10-cm visual analog scale (VAS) anchored by 2 extremes of pain (0 for no pain and 10 for extreme pain), with the patients indicating a point between these extremes.
The inclusion criteria for this study were: (1) a skeletally mature patient who agreed to participate in the study; (2) shoulder impingement syndrome that was diagnosed by one senior surgeon (CYJ) without a rotator cuff tear on the preoperative magnetic resonance image (MRI) or observed intra-operatively; (3) the patient’s symptoms were not alleviated using a conservative treatment regimen; (4) the patient had undergone arthroscopic subacromial decompression surgery. The exclusion criteria were: (1) any concomitant partial or fullthickness rotator cuff tear verified on either the preoperative MRI or intra-operatively; (2) concomitant biceps lesions (inflammation, abrasion, tear, or dislocation of the bicep in the sulcus, intraarticular, or at its origin) diagnosed arthroscopically; and (3) any history of surgical treatment on the same shoulder. Between January 2009 and December 2010, 384 consecutive patients with shoulder impingement syndrome were admitted to our institute for surgery after conservative treatment failure. Of these patients, 202 were diagnosed with full-thickness tears, and 93 patients were diagnosed with partial-thickness rotator cuff tears. The remaining 89 patients were diagnosed with impingement syndrome. Eighty of the 89 patients who met the inclusion
Surgical procedure The patient was placed in a beach-chair position. Glenohumeral inspection was first performed to confirm the absence of pathology
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Y. Lu et al.
Figure 1 (A), MRI showed that the tendon with tendinosis was intact. (B), Tendon abrasion was indicated using the scope. (C), After ASAD and debridement, microtenotomy was performed using TOPAZ. (D), Appearance of the tendon after the Topaz procedure.
on the undersurface of the rotator cuff or biceps tendon. The scope was then introduced to the subacromial space. The upper surface of the rotator cuff was inspected, and a 4.5-mm motorized shaver was used for the debridement and bursectomy. A thorough subacromial decompression was then performed as described by Neer (which includes coracoacromial ligament resection, excision of the anterolateral tip of the acromion and thorough debridement of the bursa). The surgery was completed in ASD group. In the RF group, an additional bipolar RF-based device (TOPAZ microdebrider; Arthrocare, Austin, TX, USA) connected to a System2000 generator was used. This device was placed on the tendon perpendicular to its surface, and microdebridement was performed at 5-mm intervals to cover most of the footprint region of the supraspinatus at a depth of 3 to 5 mm (Fig. 1).34
Postoperative rehabilitation Postoperative rehabilitation protocols were the same for both groups. The affected shoulder was kept in a sling for 1 week postoperatively. Assisted active ROM exercises within the patient’s tolerance was initiated on the first postoperative day. Active exercises and daily activity began on the second week. The cuff strengthening exercises were started at the beginning of the third week. Active sport-related activities were not allowed until 3 months after surgery.
Outcome measurement and statistical analysis The visual analog scale (VAS) scores were recorded at 3 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The ROM, ASES, SST, UCLA, and Constant-Murley score were recorded at 3 months, 6 months, and 1 year postoperatively.
The sample size selected for this study was based on the tenets provided by the central limit theorem, which suggests that a sample size of 30 is generally considered satisfactory in most practical situations.3 Statistical analyses were conducted using SPSS software (version 14.0; SPSS, Chicago, IL, USA). The continuous variables were tested for normality and equal variance prior to the statistical analyses. If normality and equal variance were achieved, then parametric analyses were used; if not, a nonparametric test (Wilcoxon signed rank test) was applied. The categorical variables were analyzed using Fisher’s exact test. A minimum significance level of P .05 was set for all statistical tests. A sample size estimation similar to that reported by Gartsman and O’Connor10 was used, and post hoc evaluation of study showed that the mean for the microtenotomy was equivalent to the ASD. The estimated common SD of 10 points for the postoperative Constant-Murley scores suggests that this study had sufficient power (80.6%) to show the equivalency of treatments and that a sample size of greater than 24 subjects in each group was sufficient for statistical analysis.
Results Sixty-five out of eighty patients (81.3%) were available for the final follow-up at 1 year postoperatively. All patients’ preoperative data are shown in Table I. No significant difference was found regarding age, gender, and dominant side involvement as well as the duration of symptoms, ROM, VAS score, or any preoperative functional scores between the two groups. Both treatment groups showed significantly (P ¼ .031 in the ASD group vs .017 in the RF group) reduced pain
Radiofrequency treatment for shoulder impingement syndrome Table I
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Patients’ demographics
Age Sex Dominant side involvement Duration of symptoms Pre op VAS Pre op Constant-Murley Pre-op ASES Pre-op SST Pre-op UCLA Pre-op FE Pre-op ER Pre-op IR
RF (n ¼ 33)
ASD (n ¼ 32)
P value
49.4 11.5 16：17 66.7%
50 11.2 14：18 75%
.822 .911 .802
16.6 M 5.5 1.7 66.8 20.5 61.9 13.5 6.5 3.1 17.0 5.0 133 (20–170 ) 35 (0–70 ) L1(buttock-T6)
13.8 M 5.3 2.1 68.6 15.6 63.9 9.7 6.4 3.8 17.0 5.0 133 (50–170 ) 41 (10–70 ) L1(thigh-T6)
.708 .921 .691 .585 .607 .739 .981 .338 .457
RF, radiofrequency; ASD, arthroscopic subacromial decompression; VAS, visual analog scale; ASES, American Shoulder & Elbow Surgeon’s score; SST; Simple Shoulder Test; UCLA, University of California Los Angeles; FE, forward elevation; ER, external rotation; IR, internal rotation.
3 weeks postoperatively. No significant difference was found between the 2 groups at any postoperative time point (Fig. 2 and Table II). The overall postoperative functional evaluation score including ASES, Constant-Murley, UCLA, and SST improved significantly in both treatment groups 3 months postoperatively. No significant differences were found between the 2 groups at any postoperative time point regarding the ASES, UCLA, SST, or Constant-Murley score (Figs. 3-6 and Table III). Both treatment groups showed significantly (P > .05) improved FE range (P ¼ .001 in the ASD group vs P ¼ .004 in the RF group) and ER (P ¼ .047 in the ASD group vs P ¼ .021 in the RF group) 1 year postoperatively. The range of IR in both groups improved significantly by 6 months postoperatively (P ¼ .009 in the ASD group vs P ¼ .027 in the RF group). No significant differences were found between the 2 groups at any postoperative time point (Table III).
Discussion Our results demonstrated the effects of ASD for shoulder impingement syndrome. Patients had significant pain relief 3 weeks postoperatively and significant functional recovery (Constant, UCLA, ASES and SST) within 3 months postoperatively. At the final follow up, both the Constant and ASES scores were greater than 90, the UCLA was greater than 30 and the SST was greater than 10 on average. Some previous studies reported a satisfactory effect for acromioplasty in pain relief and functional improvement in patients with impingement syndrome.2,9,25,26 Our study
Figure 2 Postoperative changes in pain score (from preoperative scores) are shown for all examination time points through 1 year postoperatively. The pain reduction profile was statistically similar for both surgical treatment groups.
showed that satisfactory results can be obtained using acromioplasty and bursa debridement in treating shoulder impingement syndrome in both groups. Our data failed to show any significant difference regarding VAS score, functional scores, or ROM between the RF group and the ASD group at any postoperative time point. We did not detect any positive effects for RFbased microtenotomy for the treatment of impingement syndrome. This result shows that arthroscopic subacromial decompression (but not RF treatment) remains a reliable treatment for refractory impingement syndrome without rotator cuff tear. It has been hypothesized that the lack of vascularity in tendinosis may compromise nutritional flow through the tendon, thus making regeneration difficult.14,15,17 The RF device (Topaz) uses a controlled plasma-mediated RF-based process. In this process, RF energy is used to excite the electrolytes in a conductive medium such as saline solution to create precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds, thus excising or dissolving soft tissue at relatively low temperatures.29,30,35 Previous studies based on cardiac and wound healing literature demonstrated the feasibility of initiating angiogenesis in tendon tissue using RF-based microtenotomy.24,27 However, in another cadaveric model, the biomechanical properties of the human patellar tendon including ultimate stress at failure, elastic modulus, strain energy density, and strain at maximum load were not significantly affected after RF-based plasma microdebridement.28,34 Taverna et al reported 60 patients who underwent ASD or RF-based plasma microtenotomy for treating chronic supraspinatus tendinosis. The author (in the RF group) removed as little bursa as required to clearly visualize the tendon, and this researcher used Topaz to perform the microtenotomy without acromioplasty. The result showed that both procedures were associated with significant improvements postoperatively, and the microtenotomy group showed
1492 Table II ASD RF P1
Y. Lu et al. Pain score measurements and time point comparisons Pre-op
3 week post-op
6 week post-op
3 month post-op
6 month post-op
1 year post-op
P2
5.3 2.1 5.5 1.7 0.921
3.1 2.1 3.9 2.3 0.361
2.8 2.0 3.2 2.0 0.502
1.9 1.5 2.2 1.9 0.713
1.0 1.6 1.4 1.9 0.379
0.3 0.9 0.4 1.1 0.631
0.031/3w 0.017/3w
ASD, arthroscopic subacromial decompression; RF, radiofrequency; P1, significant difference between 2 groups at the same time point; P2, significant difference was found (as earliest as) between 3 weeks and the preoperative time point.
Figure 3 Postoperative changes in Constant-Murley scores (from preoperative scores) are shown for all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
Figure 5 Postoperative changes in UCLA scores (from preoperative scores) are shown over all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
Figure 4 Postoperative changes in ASES scores (from preoperative scores) are shown for all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
Figure 6 Postoperative changes in SST scores (from preoperative scores) are shown over all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
a longitudinal recovery profile similar to that of the ASD group regarding VAS, Constant-Murley, UCLA, ASES and SF-36. Because the author compared 2 different treatment protocols (acromioplasty with complete bursectomy vs radiofrequency with incomplete bursectomy), the effectiveness of the treatment remains unclear.34 We performed ASD in both groups and used RF-based plasma microtenotomy in the RF group. We think that the effect of the RF-based plasma microtenotomy can be accurately tested, and believe that our results remain reliable albeit different from those of Taverna.
Our study had several limitations. First, there was no postoperative MRI evaluation, which renders impossible an assessment of whether the RF will have an impact on tendinosis recovery. Second, histological analysis was not incorporated into this study, which may favor (from a histological point of view) the advantages of RF. Third, although the follow-up physical examinations were performed by an independent observer, that observer was not blinded to the type of surgery that the patient received, which may have caused bias. Fourth, 18.7% of our patients were lost during the follow up period. The effect of this loss
Radiofrequency treatment for shoulder impingement syndrome Table III
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Functional scores, ROM measurements, and time point comparisons
ASES ASD RF P1 Constant-Murley ASD RF P1 UCLA ASD RF P1 SST ASD RF P1 Flexion-elevation ASD RF P1 External rotation ASD RF P1 Internal rotation ASD RF P1
Pre op
3 m post op
6 m post op
1 y post op
P2
61.9 13.5 63.9 9.7 0.585
79.2 8.7 75.6 9.5 0.673
83.1 7.2 86.2 8.9 0.703
90.5 7.1 91.7 7.7 0.631
0.032 (3 month) 0.042 (3 month) /
68.6 15.6 66.8 20.5 0.691
86.1 8.5 81.0 11.5 0.891
90.8 16.9 90.9 14.3 0.640
98.8 6.3 96.5 3.6 0.714
0.033 (3 month) 0.045 (3 month) /
17.0 5.0 17.0 5.0 0.739
27.4 5.9 25.1 7.1 0.756
32.1 8.7 32.4 5.6 0.720
33.2 3.3 33.5 4.8 0.586
0.021 (3 month) 0.038 (3 month) /
6.4 3.8 6.5 3.1 11.3 1.7
9.3 1.9 9.7 2.2 0.577
11.1 1.9 10.6 2.8 0.319
11.9 2.0 11.3 1.7 0.562
0.03 (3 month) 0.015 (3 month) /
133 (20–170 ) 133 (50–170 ) 0.981
148 (90–170 ) 149 (110–170 ) 0.703
157 (90–170 ) 153 (130–170 ) 0.493
159 (130–170 ) 165 (130–170 ) 0.368
0.001 (1 year) 0.004 (1 year) /
41 (0–70 ) 35 (10–70 ) 0.338
41 (10–70 ) 43 (30–60 ) 0.518
47 (10–70 ) 46 (30–60 ) 0.754
54 (30–60 ) 59 (30–60 ) 0.659
0.047 (1 year) 0.021 (1 year) /
L1(Buttock-T6) L1(Thigh-T6) 0.457
T9*(Thigh-T6) T12(L3-T6) 0.115
T7(Buttock-T6) T9(L3-T6) 0.155
T7(T12-T6) T7(T12-T6) 0.230
0.009 (6 month) 0.027 (6 month) /
ROM, range of motion; ASD, arthroscopic subacromial decompression; RF, radiofrequency; P1, significant difference between 2 groups at the same time point; P2, significant difference was found between the earliest postoperative time point and the preoperative time point (3 month for ASES, Constant, UCLA, SST; 6 month for IR and 1 year for FE, ER).
rate is greater for a prospective randomized controlled study.
any commercial entity related to the subject of this article.
Conclusion Arthroscopic subacromial decompression is a reliable treatment for refractory impingement syndrome and rotator cuff tendinosis without a tendon tear. The additional radiofrequency based plasma microtenotomy showed no significant positive effects regarding pain relief on the VAS score, ROM, or functional recovery at any given time point postoperatively.
Disclaimer None of the authors, their immediate family, nor any research foundation with which they are affiliated received any financial payments or other benefits from
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Is radiofrequency treatment effective for shoulder impingement syndrome? A prospective randomized controlled study Yi Lu, MD, PhD, Qiang Zhang, MD, Yiming Zhu, MD, PhD, Chunyan Jiang, MD* Shoulder and Elbow Service, Beijing Ji Shui Tan Hospital, School of Medicine, Peking University, Beijing, China Background: To determine whether radiofrequency based plasma microtenotomy has a positive effective in the treatment of shoulder impingement syndrome with cuff tendinosis. Materials and methods: Eighty patients with impingement syndrome and cuff tendinosis that were treated arthroscopically were enrolled in the study. The patients were randomly assigned to receive either arthroscopic subacromial decompression (ASD) alone (ASD group, n ¼ 40) or arthroscopic subacromial decompression combined with radiofrequency (RF) based plasma microtenotomy (RF group, n ¼ 40). Clinical outcome data including VAS pain score, shoulder range of motion (ROM), ASES, UCLA, ConstantMurley, and SST score were recorded preoperatively and at 3 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. Results: Sixty-five out of eighty patients (81.3%) were available for the final follow-up at 1 year postoperation. There were 32 patients in the ASD group and 33 in the RF group. Both treatment groups showed significantly (P ¼ .031 in the ASD group vs P ¼ .017 in the RF group) reduced pain 3 weeks postoperatively. Both treatment groups showed significantly improved functional scores 3 months postoperatively. Both treatment groups showed significantly improved flexion elevation (FE) and external rotation (ER) 1 year postoperatively and internal rotation (IR) 6 months postoperatively. No significant difference between the 2 groups was found in any of the outcome measurements at any time point postoperatively. Conclusion: Arthroscopic subacromial decompression is a reliable treatment for refractory impingement syndrome. The additional radiofrequency based plasma microtenotomy did not show any significant positive effects regarding pain relief, ROM, or functional recovery. Level of evidence: Level II, Randomized Controlled Trial, Treatment Study. Ó 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Arthroscopic subacromial decompression; bipolar radiofrequency; tendon debridement; shoulder surgery; topaz; microtenotomy
IRB Approval no. 2009-156: Beijing Jishuitan Hospital. *Reprint requests: Chunyan Jiang, MD, Shoulder and Elbow Service, Beijing Ji Shui Tan Hospital, School of Medicine, Peking University, No. 31 Xinjiekoudongie, 100035 Beijing, China. E-mail address: [email protected] (C. Jiang).
Shoulder impingement syndrome is a clinical entity characterized by shoulder pain, weakness, and difficulties in daily activities often associated with pathology in the subacromial bursa and lesions of the supraspinatus tendon. Neer’s description of this entity in 197222 greatly enhanced our understanding of the pathophysiology and the treatment
1058-2746/$ - see front matter Ó 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. http://dx.doi.org/10.1016/j.jse.2013.06.006
Radiofrequency treatment for shoulder impingement syndrome
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of this disease. Subacromial decompression, which includes removing the undersurface of the anterior aspect of the acromion, resecting the coracoacromial ligament, subacromial bursectomy, and debridement, had been accepted as the ‘‘golden standard’’ of treatment.23 Ellman et al8 observed an 88% success rate at 1-3 years postoperatively, using Neer’s technique for arthroscopic subacromial decompression in patients with advanced stage II impingement without a rotator cuff tear. De Baere et al6 also reported a significant postoperative improvement in pain and range of motion (ROM). The mechanism of the bipolar radiofrequency-(RF) based device can create a chemical process that excites the water molecules in an electrolyte solution and then generates excited radicals, breaks molecular bonds and excises soft tissue at relatively low temperatures (typically 40-70 C).29,30,35 This device is designed to ablate small segments of the tendon (a process called microtenotomy) and leave the remainder intact, as well as stimulate the release of angiogenic growth factors that promote tendon healing.12,18 Previous studies reported that RF-based plasma microtenotomy showed success in treating tendonitis of the lateral epicondyle, plantar fascia, patellar tendon and Achilles tendon.1,12,20,31-33 There have been biomechanical and clinical studies on the effects of radiofrequency treatment on supraspinatus tendonitis, but the conclusions of these studies remain controversial.3,28,34 The purpose of this study was to determine whether RF-based plasma microtenotomy has a positive effect in the treatment of shoulder impingement syndrome.
criteria and agreed to participate were enrolled in the study. The mean duration from the onset of the symptoms to surgery was 15.2 months (range, 6 months to 2 years). All patients had a positive Neer’s sign (the patient felt pain when the arm was brought into full elevation in the scapular plane with the arm internally rotated by the examiner), Hawkins’ sign (the patient felt pain when the arm was forcibly internally rotated with the shoulder placed in 90 of forward flexion and the elbow was bent 90 by the examiner) and Jobe’s test (pain or weakness presented when the patient resists a downward force applied by the examiner to the wrist with the arm at 90 of elevation in the scapular plane with an internal rotation with the thumb pointing down). All patients presented with supraspinatus tendinosis on the preoperative MRI but showed no evidence of any discontinuation of the rotator cuff tendon. None of the patients responded to 8 weeks of physical therapy (including rest, ice, activity modification, nonsteroidal antiinflammatory drug administration, ROM exercises, and strengthening) first and (if the treatment did not result in a positive outcome) a subacromial corticosteroid injection (0.5 ml of Diprospan, 1 ml of Ropivacaine, and 1% Lidocaine with 2.5 ml of saline injected just below the anteroinferior corner of the acromion13) combined with an additional 12 weeks of therapy. All patients then underwent arthroscopic subacromial decompression. Patients were randomly assigned to receive either arthroscopic subacromial decompression (ASD) alone (ASD group, n ¼ 40) or arthroscopic subacromial decompression combined with RF-based plasma microtenotomy (RF group, n ¼ 40). Randomization was accomplished through the use of a random numbers list generated by software and kept by the operating room nurse. Prior to the surgery, the circulating nurse reviewed the random numbers list. Patients who had been assigned an odd number were subsequently treated with only acromioplasty, and those who had been assigned an even number were managed with both acromioplasty and RF treatment.
Methods
Preoperative evaluation
Study design
All of the preoperative and follow-up evaluations were performed by the same independent observer who was involved in neither the outpatient care nor the surgery. The active range of shoulder motion was measured with a standard goniometer. The forward elevation (FE) was measured on the scapular plane under the patients’ own power while sitting. The external rotation (ER) at the side was measured using the angle between the long axis of the forearm when externally rotating and the same axis when the forearm was at the neutral position with the elbow flexed to 90 . The internal rotation (IR) was measured as the tip of the thumb to the highest level of the back. The American Shoulder & Elbow Surgeon’s (ASES) score,21 Simple Shoulder Test (SST) questionnaire,19 University of California Los Angeles (UCLA) score,7 and Constant-Murley score were recorded to evaluate shoulder function.4,5,11,16 The severity of pain was graded on a 10-cm visual analog scale (VAS) anchored by 2 extremes of pain (0 for no pain and 10 for extreme pain), with the patients indicating a point between these extremes.
The inclusion criteria for this study were: (1) a skeletally mature patient who agreed to participate in the study; (2) shoulder impingement syndrome that was diagnosed by one senior surgeon (CYJ) without a rotator cuff tear on the preoperative magnetic resonance image (MRI) or observed intra-operatively; (3) the patient’s symptoms were not alleviated using a conservative treatment regimen; (4) the patient had undergone arthroscopic subacromial decompression surgery. The exclusion criteria were: (1) any concomitant partial or fullthickness rotator cuff tear verified on either the preoperative MRI or intra-operatively; (2) concomitant biceps lesions (inflammation, abrasion, tear, or dislocation of the bicep in the sulcus, intraarticular, or at its origin) diagnosed arthroscopically; and (3) any history of surgical treatment on the same shoulder. Between January 2009 and December 2010, 384 consecutive patients with shoulder impingement syndrome were admitted to our institute for surgery after conservative treatment failure. Of these patients, 202 were diagnosed with full-thickness tears, and 93 patients were diagnosed with partial-thickness rotator cuff tears. The remaining 89 patients were diagnosed with impingement syndrome. Eighty of the 89 patients who met the inclusion
Surgical procedure The patient was placed in a beach-chair position. Glenohumeral inspection was first performed to confirm the absence of pathology
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Figure 1 (A), MRI showed that the tendon with tendinosis was intact. (B), Tendon abrasion was indicated using the scope. (C), After ASAD and debridement, microtenotomy was performed using TOPAZ. (D), Appearance of the tendon after the Topaz procedure.
on the undersurface of the rotator cuff or biceps tendon. The scope was then introduced to the subacromial space. The upper surface of the rotator cuff was inspected, and a 4.5-mm motorized shaver was used for the debridement and bursectomy. A thorough subacromial decompression was then performed as described by Neer (which includes coracoacromial ligament resection, excision of the anterolateral tip of the acromion and thorough debridement of the bursa). The surgery was completed in ASD group. In the RF group, an additional bipolar RF-based device (TOPAZ microdebrider; Arthrocare, Austin, TX, USA) connected to a System2000 generator was used. This device was placed on the tendon perpendicular to its surface, and microdebridement was performed at 5-mm intervals to cover most of the footprint region of the supraspinatus at a depth of 3 to 5 mm (Fig. 1).34
Postoperative rehabilitation Postoperative rehabilitation protocols were the same for both groups. The affected shoulder was kept in a sling for 1 week postoperatively. Assisted active ROM exercises within the patient’s tolerance was initiated on the first postoperative day. Active exercises and daily activity began on the second week. The cuff strengthening exercises were started at the beginning of the third week. Active sport-related activities were not allowed until 3 months after surgery.
Outcome measurement and statistical analysis The visual analog scale (VAS) scores were recorded at 3 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The ROM, ASES, SST, UCLA, and Constant-Murley score were recorded at 3 months, 6 months, and 1 year postoperatively.
The sample size selected for this study was based on the tenets provided by the central limit theorem, which suggests that a sample size of 30 is generally considered satisfactory in most practical situations.3 Statistical analyses were conducted using SPSS software (version 14.0; SPSS, Chicago, IL, USA). The continuous variables were tested for normality and equal variance prior to the statistical analyses. If normality and equal variance were achieved, then parametric analyses were used; if not, a nonparametric test (Wilcoxon signed rank test) was applied. The categorical variables were analyzed using Fisher’s exact test. A minimum significance level of P .05 was set for all statistical tests. A sample size estimation similar to that reported by Gartsman and O’Connor10 was used, and post hoc evaluation of study showed that the mean for the microtenotomy was equivalent to the ASD. The estimated common SD of 10 points for the postoperative Constant-Murley scores suggests that this study had sufficient power (80.6%) to show the equivalency of treatments and that a sample size of greater than 24 subjects in each group was sufficient for statistical analysis.
Results Sixty-five out of eighty patients (81.3%) were available for the final follow-up at 1 year postoperatively. All patients’ preoperative data are shown in Table I. No significant difference was found regarding age, gender, and dominant side involvement as well as the duration of symptoms, ROM, VAS score, or any preoperative functional scores between the two groups. Both treatment groups showed significantly (P ¼ .031 in the ASD group vs .017 in the RF group) reduced pain
Radiofrequency treatment for shoulder impingement syndrome Table I
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Patients’ demographics
Age Sex Dominant side involvement Duration of symptoms Pre op VAS Pre op Constant-Murley Pre-op ASES Pre-op SST Pre-op UCLA Pre-op FE Pre-op ER Pre-op IR
RF (n ¼ 33)
ASD (n ¼ 32)
P value
49.4 11.5 16：17 66.7%
50 11.2 14：18 75%
.822 .911 .802
16.6 M 5.5 1.7 66.8 20.5 61.9 13.5 6.5 3.1 17.0 5.0 133 (20–170 ) 35 (0–70 ) L1(buttock-T6)
13.8 M 5.3 2.1 68.6 15.6 63.9 9.7 6.4 3.8 17.0 5.0 133 (50–170 ) 41 (10–70 ) L1(thigh-T6)
.708 .921 .691 .585 .607 .739 .981 .338 .457
RF, radiofrequency; ASD, arthroscopic subacromial decompression; VAS, visual analog scale; ASES, American Shoulder & Elbow Surgeon’s score; SST; Simple Shoulder Test; UCLA, University of California Los Angeles; FE, forward elevation; ER, external rotation; IR, internal rotation.
3 weeks postoperatively. No significant difference was found between the 2 groups at any postoperative time point (Fig. 2 and Table II). The overall postoperative functional evaluation score including ASES, Constant-Murley, UCLA, and SST improved significantly in both treatment groups 3 months postoperatively. No significant differences were found between the 2 groups at any postoperative time point regarding the ASES, UCLA, SST, or Constant-Murley score (Figs. 3-6 and Table III). Both treatment groups showed significantly (P > .05) improved FE range (P ¼ .001 in the ASD group vs P ¼ .004 in the RF group) and ER (P ¼ .047 in the ASD group vs P ¼ .021 in the RF group) 1 year postoperatively. The range of IR in both groups improved significantly by 6 months postoperatively (P ¼ .009 in the ASD group vs P ¼ .027 in the RF group). No significant differences were found between the 2 groups at any postoperative time point (Table III).
Discussion Our results demonstrated the effects of ASD for shoulder impingement syndrome. Patients had significant pain relief 3 weeks postoperatively and significant functional recovery (Constant, UCLA, ASES and SST) within 3 months postoperatively. At the final follow up, both the Constant and ASES scores were greater than 90, the UCLA was greater than 30 and the SST was greater than 10 on average. Some previous studies reported a satisfactory effect for acromioplasty in pain relief and functional improvement in patients with impingement syndrome.2,9,25,26 Our study
Figure 2 Postoperative changes in pain score (from preoperative scores) are shown for all examination time points through 1 year postoperatively. The pain reduction profile was statistically similar for both surgical treatment groups.
showed that satisfactory results can be obtained using acromioplasty and bursa debridement in treating shoulder impingement syndrome in both groups. Our data failed to show any significant difference regarding VAS score, functional scores, or ROM between the RF group and the ASD group at any postoperative time point. We did not detect any positive effects for RFbased microtenotomy for the treatment of impingement syndrome. This result shows that arthroscopic subacromial decompression (but not RF treatment) remains a reliable treatment for refractory impingement syndrome without rotator cuff tear. It has been hypothesized that the lack of vascularity in tendinosis may compromise nutritional flow through the tendon, thus making regeneration difficult.14,15,17 The RF device (Topaz) uses a controlled plasma-mediated RF-based process. In this process, RF energy is used to excite the electrolytes in a conductive medium such as saline solution to create precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds, thus excising or dissolving soft tissue at relatively low temperatures.29,30,35 Previous studies based on cardiac and wound healing literature demonstrated the feasibility of initiating angiogenesis in tendon tissue using RF-based microtenotomy.24,27 However, in another cadaveric model, the biomechanical properties of the human patellar tendon including ultimate stress at failure, elastic modulus, strain energy density, and strain at maximum load were not significantly affected after RF-based plasma microdebridement.28,34 Taverna et al reported 60 patients who underwent ASD or RF-based plasma microtenotomy for treating chronic supraspinatus tendinosis. The author (in the RF group) removed as little bursa as required to clearly visualize the tendon, and this researcher used Topaz to perform the microtenotomy without acromioplasty. The result showed that both procedures were associated with significant improvements postoperatively, and the microtenotomy group showed
1492 Table II ASD RF P1
Y. Lu et al. Pain score measurements and time point comparisons Pre-op
3 week post-op
6 week post-op
3 month post-op
6 month post-op
1 year post-op
P2
5.3 2.1 5.5 1.7 0.921
3.1 2.1 3.9 2.3 0.361
2.8 2.0 3.2 2.0 0.502
1.9 1.5 2.2 1.9 0.713
1.0 1.6 1.4 1.9 0.379
0.3 0.9 0.4 1.1 0.631
0.031/3w 0.017/3w
ASD, arthroscopic subacromial decompression; RF, radiofrequency; P1, significant difference between 2 groups at the same time point; P2, significant difference was found (as earliest as) between 3 weeks and the preoperative time point.
Figure 3 Postoperative changes in Constant-Murley scores (from preoperative scores) are shown for all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
Figure 5 Postoperative changes in UCLA scores (from preoperative scores) are shown over all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
Figure 4 Postoperative changes in ASES scores (from preoperative scores) are shown for all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
Figure 6 Postoperative changes in SST scores (from preoperative scores) are shown over all examination time points through 1 year postoperatively. Improvements in scores over time were statistically similar for both surgical treatment groups.
a longitudinal recovery profile similar to that of the ASD group regarding VAS, Constant-Murley, UCLA, ASES and SF-36. Because the author compared 2 different treatment protocols (acromioplasty with complete bursectomy vs radiofrequency with incomplete bursectomy), the effectiveness of the treatment remains unclear.34 We performed ASD in both groups and used RF-based plasma microtenotomy in the RF group. We think that the effect of the RF-based plasma microtenotomy can be accurately tested, and believe that our results remain reliable albeit different from those of Taverna.
Our study had several limitations. First, there was no postoperative MRI evaluation, which renders impossible an assessment of whether the RF will have an impact on tendinosis recovery. Second, histological analysis was not incorporated into this study, which may favor (from a histological point of view) the advantages of RF. Third, although the follow-up physical examinations were performed by an independent observer, that observer was not blinded to the type of surgery that the patient received, which may have caused bias. Fourth, 18.7% of our patients were lost during the follow up period. The effect of this loss
Radiofrequency treatment for shoulder impingement syndrome Table III
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Functional scores, ROM measurements, and time point comparisons
ASES ASD RF P1 Constant-Murley ASD RF P1 UCLA ASD RF P1 SST ASD RF P1 Flexion-elevation ASD RF P1 External rotation ASD RF P1 Internal rotation ASD RF P1
Pre op
3 m post op
6 m post op
1 y post op
P2
61.9 13.5 63.9 9.7 0.585
79.2 8.7 75.6 9.5 0.673
83.1 7.2 86.2 8.9 0.703
90.5 7.1 91.7 7.7 0.631
0.032 (3 month) 0.042 (3 month) /
68.6 15.6 66.8 20.5 0.691
86.1 8.5 81.0 11.5 0.891
90.8 16.9 90.9 14.3 0.640
98.8 6.3 96.5 3.6 0.714
0.033 (3 month) 0.045 (3 month) /
17.0 5.0 17.0 5.0 0.739
27.4 5.9 25.1 7.1 0.756
32.1 8.7 32.4 5.6 0.720
33.2 3.3 33.5 4.8 0.586
0.021 (3 month) 0.038 (3 month) /
6.4 3.8 6.5 3.1 11.3 1.7
9.3 1.9 9.7 2.2 0.577
11.1 1.9 10.6 2.8 0.319
11.9 2.0 11.3 1.7 0.562
0.03 (3 month) 0.015 (3 month) /
133 (20–170 ) 133 (50–170 ) 0.981
148 (90–170 ) 149 (110–170 ) 0.703
157 (90–170 ) 153 (130–170 ) 0.493
159 (130–170 ) 165 (130–170 ) 0.368
0.001 (1 year) 0.004 (1 year) /
41 (0–70 ) 35 (10–70 ) 0.338
41 (10–70 ) 43 (30–60 ) 0.518
47 (10–70 ) 46 (30–60 ) 0.754
54 (30–60 ) 59 (30–60 ) 0.659
0.047 (1 year) 0.021 (1 year) /
L1(Buttock-T6) L1(Thigh-T6) 0.457
T9*(Thigh-T6) T12(L3-T6) 0.115
T7(Buttock-T6) T9(L3-T6) 0.155
T7(T12-T6) T7(T12-T6) 0.230
0.009 (6 month) 0.027 (6 month) /
ROM, range of motion; ASD, arthroscopic subacromial decompression; RF, radiofrequency; P1, significant difference between 2 groups at the same time point; P2, significant difference was found between the earliest postoperative time point and the preoperative time point (3 month for ASES, Constant, UCLA, SST; 6 month for IR and 1 year for FE, ER).
rate is greater for a prospective randomized controlled study.
any commercial entity related to the subject of this article.
Conclusion Arthroscopic subacromial decompression is a reliable treatment for refractory impingement syndrome and rotator cuff tendinosis without a tendon tear. The additional radiofrequency based plasma microtenotomy showed no significant positive effects regarding pain relief on the VAS score, ROM, or functional recovery at any given time point postoperatively.
Disclaimer None of the authors, their immediate family, nor any research foundation with which they are affiliated received any financial payments or other benefits from
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