Effect of Shockwave Treatment for Management of Upper and Lower Extremity Musculoskeletal Conditions: A Narrative Review

1 2 3 4 5 PM R XXX (2018) 1-18 www.pmrjournal.org 6 7 8 9 10 11 12 13 14 15 16 17 18 19 Q14 20 21 22 23 24 25 Abstract 26 27 Extracorporeal shockwave therapy (ESWT) is a technology that was first introduced into clinical practice in 1982 for urologic 28 29 conditions. Subsequent clinical applications in musculoskeletal conditions have been described in treatment of plantar fasciop30 athy, both upper and lower extremity tendinopathies, greater trochanteric pain syndrome, medial tibial stress syndrome, 31 management of nonunion fractures, and joint disease including avascular necrosis. The aim of this review is to summarize the 32 33 current understanding of treatment of musculoskeletal conditions with ESWT, accounting for differences in treatment protocol 34 and energy levels. Complications from ESWT are rare but include 2 reported cases of injury to bone and Achilles tendon rupture in 35 older adults using focused shockwave. Collectively, studies suggest ESWT is generally well-tolerated treatment strategy for 36 multiple musculoskeletal conditions commonly seen in clinical practice. 37 38 Level of Evidence: --39 40 Key words: shockwave; Achilles tendinitis; plantar fasciitis; hamstring tendinopathy; lateral epicondylitis 41 42 43 44 45 including lateral epicondylitis [8,9] and rotator cuff Introduction 46 tendinopathy [10], as well as lower extremity condi47 48 tions, including Achilles tendinopathy [11], patellar Extracorporeal shockwave therapy (ESWT) was first 49 tendinopathy [12], hamstring tendinopathy [13], and introduced into clinical practice in 1982 for urinary 50 51 greater trochanteric pain syndrome (GTPS) [14,15]. stone lithotripsy [1]. This technology revolutionized the 52 Despite the study of ESWT for more than 3 decades, approach to nephrolithiasis management, and quickly 53 54 no standardized protocol exists for the treatment of became adopted as a first-line, noninvasive, and 55 musculoskeletal conditions. Several variables differ effective method for treatment of urinary stones [2]. 56 between research studies, including energy flux density Soon thereafter, ESWT was studied in Orthopedics, as it 57 58 (EFD), number of impulses, type of wave (focused or was hypothesized that ESWT could loosen the cement in 59 radial), device used, number of treatment sessions, total hip arthroplasty revisions [3]. Animal studies con60 61 days between sessions, area of application, and use of ducted in the 1980s revealed that not only could 62 analgesia during application. Additionally, research shockwaves disturb the bone-cement interface [4] but 63 protocols vary in recommendations for activity restricalso found an osteogenic response and improved frac64 65 tion after treatment and the adjuvant treatment with ture healing [5]. Although there is continued evidence 66 physical therapy, eccentric loading, stretching, and use for the use of ESWT for fracture healing [6], the ma67 68 of nonsteroidal anti-inflammatory drugs (NSAIDs). There jority of orthopedic research has focused on ESWT for 69 is also variation in the definition of conservative treattreatment of upper and lower extremity tendino70 ment, the outcome measures, and length of follow-up pathies, fasciopathies, and soft tissue conditions. 71 72 among studies. Pain is the primary endpoint for most Shockwave was first studied in the treatment of 73 investigations, with few other outcome measures plantar fasciitis in 1996 [7]. The application was subse74 75 reported. quently studied for upper extremity conditions, 76 77 78 1934-1482 ª 2018 by the American Academy of Physical Medicine and Rehabilitation. This is an open access article under the CC BY-NC-ND license 79 (http://creativecommons.org/licenses/by-nc-nd/4.0/) 80

Narrative Review

Narrative Review on the Effect of Shockwave Treatment for Management of Upper and Lower Extremity Musculoskeletal Conditions Julia M. Reilly, Eric Bluman, Adam S. Tenforde

https://doi.org/10.1016/j.pmrj.2018.05.007

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Extracorporeal Shockwave Therapy

The clinical application of ESWT has been a controversial issue in the past, because of the mixed results in research studies. However, there is a mounting body of literature that appears to suggest that ESWT may be effective in treating a subset of chronic tendon and plantar fascia diseases for a subset of patients [16]. The purpose of this review is to synthesize the current available research on the use of ESWT for management of upper and lower extremity musculoskeletal conditions and identify best evidence for treatment. Physiology of Extracorporeal Shockwave Therapy Shockwaves are sound waves that have certain physical characteristics, including nonlinearity, high peak pressure followed by low tensile amplitude, short rise time, and short duration (10 ms). These characteristics generate a positive and negative phase of shockwave. The positive phase produces direct mechanical forces, whereas the negative phase generates cavitation and gas bubbles that subsequently implode at high speeds, generating a second wave of shockwaves [17]. When compared to ultrasound waves, the shockwave peak pressure is approximately 1000 times greater than the peak pressure of an ultrasound wave [16]. Focused shockwave therapy and radial shockwave therapy are 2 types of shockwave therapy used in clinical practice. Focused shockwaves are generated by electrohydraulic, electromagnetic, and piezoelectric devices. Radial shockwaves are typically produced by pneumatic/ballistic devices [17]. Much of the early research in ESWT for musculoskeletal conditions utilized focused shockwave therapy [17]. Focused shockwaves have higher energy and generate maximal force at a selected depth, whereas radial shockwaves are lower energy and generate highest pressure at the skin surface with subsequent weakening at greater depth [18]. Ioppolo defined energy flux density as the energy per impulse at the focal point of the shockwave [19]. In a study by Rompe et al in 1998, the authors classified high EFD as 0.6 mJ/mm2, medium as 0.28 mJ/mm2, and low as 0.08 mJ/mm2 [20]. In this study, the high energy flux application to tendon in an animal model led to persistent histopathologic changes, including inflammation, necrosis, and disorganized fibrocysts. Based on these findings, the authors suggested energy levels exceeding 0.28 mJ/mm2 may not be appropriate for clinical use in tendon disorders [20]. Mechanism of Action/Theoretical Application in Humans

osteoprogenitor differentiation [23], increasing leukocyte infiltration [20], and amplifying growth factor and protein synthesis to stimulate collagen synthesis and tissue remodeling [22-25]. ESWT may reduce pain through hyperstimulation of nociceptors/gate-control theory of pain transmission, altered pain receptor neurotransmission, and by increasing local paininhibiting substances [26-29]. Stimulation of nociceptive C-fibers may not only play a role in analgesia, but also in tendon remodeling, as it may increase release of neuropeptides, causing fibroblast stimulation and vasodilation [30]. A list of additional proposed mechanisms of action of ESWT is included in Table 1. Methodology of Review The conditions treated are divided into disease states. The primary articles were identified using PubMed search in September 2017 using a combination of the following search terms: shock wave therapy, ESWT, extracorporeal shockwave therapy, tendinopathy, and fasciopathy. The primary articles were used to identify additional articles by cross-reference. Because of limited total articles identified, we included both retrospective and prospective studies and noted whether studies included a control group, were blinded, and use of placebo. Additionally, the primary and secondary outcome measures for each study were reported. Studies were each scored by 2 observers using Physiotherapy Evidence Database scale (PEDro) criterion to determine study quality [31]. A score that meets 7 of the 11 criteria has been described as high quality and externally valid in prior meta-analysis using this criterion [32]. All studies scored
7 with the exception of one study that scored 6 [33]. To quantify the type of shockwave treatment, study design, and protocol, studies included are listed in Tables 2-10. Subject Populations Many of the studied musculoskeletal conditions are self-limiting diseases. As a result, most studies enrolled patients who had failed multiple conservative treatment options and were considered to have recalcitrant disease processes. Exclusion criteria in subjects often included local arthritis, generalized polyarthritis, rheumatoid arthritis, ankylosing spondylitis, reactive arthritis, nerve entrapments, prior surgeries at the site, pregnancy, infections, tumors, or use of systemic anticoagulation. Lower Extremity Pathology Plantar Fasciitis

The effects of ESWT treatment are unknown. Proposed mechanisms of action for ESWT include promoting neovascularization at the tendon-bone junction [21], stimulating proliferation of tenocytes [22] and

Shockwave therapy has been studied in the treatment of plantar fasciitis since 1996, with favorable results initially reported in treatment of patients with

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Table 1 Proposed mechanisms of action for shockwave Neovascularization at tendon-bone junction Destruction of calcifications Increased collagen synthesis/tissue remodeling Leukocyte infiltration Proliferation of tenocytes Increased glycosaminoglycan, increased protein synthesis Increased IL-6, IL-8, MMP-2, MMP-9, increased collagen synthesis Increased TGF-b1 and IGF-1, increase collagen synthesis Mechanotransduction, increasing collagen synthesis Increased osteoprogenitor differentiation Stimulation of nociceptive C-fibersdcausing release of neuropeptidesdperipherally can stimulate vasodilation, stimulate fibroblasts Nociceptor hyperstimulation/Gate-control theory Increase in local pain-inhibiting substances Impaired cell membrane receptor potential

Wang 2002, Wang 2003 Peters 2004 Bosch 2007, Vetrano 2011 Rompe 1998 Chen 2004 Bosch 2007 Waugh 2015 Wang 2002, Chen 2004, Khan 2009 Banes 1995, Khan 2009 Wang 2002 Klonchinski 2011 Saggini 2015, Wess 2008, Vahdatpour 2013, Zimmerman 2008 Saggini 2015, Wess 2008, Vahdatpour 2013, Zimmerman 2008 Wess 2008

IL ¼ insulin; MMP ¼ matrix metalloproteinase; TGF-b1 ¼ transforming growth factorebeta 1; IGF-1 ¼ insulin-like growth factor 1.

plantar calcaneal spurs [7]. One early study demonstrating efficacy was a randomized controlled trial (RCT) by Kudo et al that examined 114 patients with a history of plantar fasciitis for 6 months or greater [34]. Investigators randomized patients to an active treatment group that would receive a single treatment session of ESWT or placebo. All patients were administered a medial calcaneal nerve block prior to ESWT or sham treatment. The ESWT flux density was incrementally increased to a “high-energy” density. At the 3-month endpoint, the ESWT population was found to have a statistically significant improvement in visual analog scale (VAS) pain scores and Roles-Maudsley scores as compared to the placebo group [34]. Gollwitzer et al studied 246 patients with chronic plantar fasciitis [35]. Subjects were randomized to receive sham or ESWT at weekly intervals for 3 total sessions. The total EFD was uptitrated to 0.25 mJ/mm2 with 500 introductory impulses, and thereafter treated with that energy for 2000 treatment impulses. Primary outcomes for treatment success included (A) percentage change in heel pain composite VAS score: composed of pain with first morning steps, pain during daily activities, and pain while applying standardized pressure, and (B) improvement in Roles-Maudsley score. At 12 weeks, the success rate of ESWT for pain reduction was 54.4% compared to 37.2% for the placebo group (P ¼ .0035, OR 2.015, number needed to treat 5.8) [35]. Rompe et al conducted a randomized, single-blind study in 2015 in which patients were randomized to receive either 3 weekly sessions of low-energy radial shockwave, or combined treatment with ESWT and 8 weeks of a plantar fascia stretching program [36]. All patients received 2000 pulses with an EFD of 0.16 mJ/mm2, applied to the area of maximal tenderness. After receiving instructions and supervision, patients in the stretching group were asked to perform stretching exercises 3 times daily, for 8 weeks. Eight weeks after

baseline assessment, both groups were observed to have improvements in pain; however, subjects instructed to stretch were noted to have greater improvement over those receiving ESWT as monotherapy. The outcomes in the stretching group remained improved up to 4 months, then became similar to those of the non-stretching group at 24 months [36]. Three randomized-control trials did not demonstrate efficacy of ESWT over other treatments for management of chronic plantar fasciitis [37-39]. These 3 studies have been criticized because of methodology issues in treatment protocols [40]. Gollwitzer [35] reported favorable results for treatment of plantar fasciitis in a large RCT, and suggested use of local anesthesia (Haake), lower energy levels (Speed), and anatomical landmarks rather than palpation guidance to direct treatment (Buchbinder) as potential issues in the protocols of the 3 RCTs. The use of local anesthesia prior to ESWT has been found to reduce the efficacy of treatment [41]. Compared to the Kudo study that reported a favorable response to ESWT with multiple treatments [34], the active treatment group in the Speed study received a lower energy treatment (1500 pulses at 0.12 mJ/mm2) or sham treatment for 3 total sessions administered on a monthly basis. The primary outcome was measured at 3 months following completion of treatment, with a positive response graded as a 50% improvement in VAS score. Seventeen (37%) patients in the active treatment group reported 50% improvement at 3 months, as compared to 10 (24%) of the sham treatment group (P ¼ .248, relative risk ¼ 0.827, 95% confidence interval [CI] 0.626-1.093) [38]. Three meta-analyses were performed to evaluate the clinical response of plantar fasciitis to ESWT, each measuring different clinical outcomes. In 2005, Thomson et al [42] performed a meta-analysis examining 11 RCTs published between 1996-2003, including the 3 RCTs that did not demonstrate efficacy [37-39]. Two of the

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Extracorporeal Shockwave Therapy

Table 2 Upper extremity studies characterizing effects of shockwave on management by condition: Lateral epicondylitis

Author

Study No. of Subject Design Subjects Population

Minimum Duration of Symptoms

Haake 2002

RCT

271

Nonathletes

Speed 2002

RCT

75

Nonathletes

Melikyan 2003 RCT

74

Nonathletes, Not specified on waiting list for surgery

Rompe 2004

RCT

Chung 2004

Type of Shock

6 mo

Various devices, unspecified

Unspecified 2000 pulses

ED þ 0.07-0.09 mJ/mm2

3; weekly

3 mo

Sonocur Plus

FWST

1500 pulses

0.18 mJ/mm2, placeboeplacebo 0.04 mJ/mm2

3; monthly

Dornier Epos Ultra

FWST

Variable

333 mJ/mm2 each session, 1000 mJ/mm2 total

3; unclear

78

Sonocur Plus Recreational 12 mo, not responsive tennis to 3 conservative players therapies

FWST

2000 pulses/ 4 Hz

0.09 mJ/mm2, total dose 0.54 mJ/mm2

3; weekly

RCT

60

Nonathletes

3 wke1 y maximum

FWST

2000 pulses

0.03-0.17 mJ/mm2, 3; weekly placebo 0.03 mJ/mm2

Pettrone 2005 RCT

114

Nonathletes

Sonocur 6 mo, resistant to (unspecified) 2/3 conventional therapies

FWST

2000 pulses

0.06 mJ/mm2

68

Nonathletes

6 wk

Staples 2008

RCT

Sonocur Basic

Dornier MedTech FWST Epos

Impulses/ Frequency

No. of Sessions/ Interval

Shockwave Device

EFD

Treatment: 2000 Variable-Median pulses/wk, total dose energy as tolerated 1062 mJ/mm2/wk, placebo total dose by patient. Placebo: 6 mJ/mm2 100 shocks/wk, 4 Hz

3; weekly

3; weekly

EFD ¼ electron flux density; RCT ¼ randomized controlled trial; ED ¼ ---; FWST ¼ ---; VAS ¼ visual analog scale; UEFS ¼ Upper Extremity Functional Scale; ESWT ¼ extracorporeal shockwave therapy; UE ¼ upper extremity; EQ5D ¼ EuroQol 5D; NSAID ¼ nonsteroidal anti-inflammatory drug; ADLs ¼ activities of daily living; DASH ¼ Disabilities of the Arm, Shoulder, and Hand; QoL ¼ quality of life; SF-36 ¼ 36-Item Short Form Health Survey.

11 trials did not require the patients to have had symptoms for greater than 6 months, and 3 of the trials used a low dose of ESWT as the control treatment. Outcome measures were obtained at 12 weeks posttreatment in all but 1 trial, which obtained outcome measures at 19 weeks. The pooled analysis from 6 trials revealed a statistically significant but small treatment effect (P ¼ .04, 95% CI 0.02-0.83). The resulting reduced

pain equated to a change on a 10-cm VAS, of less than a half-centimeter [42]. In 2013, Dizon et al [32] performed a meta-analysis of 11 RCTs published between 1990-2010, all in subjects with heel pain for longer than 6 months. The studies were classified as using low-intensity (<0.1 mJ/mm2), moderate intensity (0.1-0.2 mJ/mm2), and highintensity shockwave (>0.2 mJ/mm2). This review also

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Table 2 Continued Local Anesthesia Yes

Area Applied

Adjuvant Treatment

Follow-up

Primary Outcomes

Secondary Outcomes

Results

Not specified

6, 12 wk, 12 mo

Roles-Maudsley Scores, Pain on 11-point scale, grip strength Not specified

No significant difference at time points

No significant difference between placebo and control at any time point, in any outcomes. 46% of treatment group patients underwent surgery, 43% in the control group At 3 mo, statistically significant difference in pain on VAS, RM score, UEFS, Satisfaction. No difference in grip strength. At 12 mo, 71% of ESWT patients returned to playing, 55% of placebo group, P ¼ .165 No significant difference between groups in treatment success.

Landmark, ultrasound guidance Ultrasound guidance, maximal tenderness Landmark, ultrasound guidance

Not specified

1, 2, 3 mo from baseline (1 mo after completion)

Roles-Maudsley (RM) score 1 or 2, and no additional treatment 50% improvement from baseline at 3 mo in day pain or night pain on VAS

Not specified. No restrictions on activities.

1, 3, 12 mo after last treatment

Surgery or removal from waiting list

DASH function/ symptom score, pain on VAS, grip strength, analgesic requirement

No

Maximal tenderness/ clinical focusing technique

Could use pretreatment splint/braces, but no other treatments until the 3-mo follow-up. No pain medications

3, 12 mo post-treatment

Reduction in pain on VAS at 3 mo on Thomsen Test, >30% decrease in .pain on VAS

Pain reduction on VAS, Roles-Maudsley Score, UEFS, grip strength, overall satisfaction

Not specified

Maximal Tenderness

Forearm stretching program

4, 8 wk after initiation of therapy

No

Maximal tenderness/ clinical focusing technique

Not specified

1, 4, 8, 12 wk, 6, 12 mo after completion

Treatment success: >50% reduction in overall pain on VAS, maximum allowable overall pain of 4 on VAS, No use of pain med for elbow pain for 2 wk before the 8-wk follow-up Improved pain with Thomsen test on VAS at 12 wk

Pain on VASe overall, rest, during sleep, during activity, pain at worst, pain at least, pain with activity, QoL on EQ5D, pain-free maximum grip strength Pain on Thomsen testing, Functional scale, Activity score, grip strength, subjective evaluation (patient)

Not specified

Ultrasound guidance, maximal tenderness

Instructed in standard stretching, could wear braces/splints, instructed to hold NSAIDs 2 wk prior to study. No other interventions during first 6 wk.

6 wk, 3, 6 mo after completion of treatment

Pain on VAS, Function on VAS, Discomfort in ADLs, DASH, QoL on SF-36, Health Status Questionnaire, maximum pain-free grip strength/ maximum grip strength on dynamometer, problem elicitation technique

Not specified

No

Not specified

included the RCTs by Haake, Buchbinder, and Speed [37-39]. The authors found that there was no difference in decreasing overall pain; however, a subgroup analysis revealed that moderate-intensity ESWT was effective in decreasing overall pain (P < .00001) and activity pain (P ¼ .001). ESWT was also found to be effective in decreasing morning pain (P ¼ .004) and increasing functional outcome (P ¼ .0001). The study data suggest that moderate- and high-intensity ESWT were superior

No significant difference in pain between groups

Statistically significant improvement in pain, UE function, and activity between treatment groups at 12 wk. Grip strength improved but not significantly. No significant differences in outcomes between ESWT and placebo, except in 3-mo DASH (favored treatment group)

to low-intensity ESWT in management of chronic plantar fasciitis [32]. Lou et al [43] conducted a meta-analysis in 2017 that examined 9 RCTs published between 2001 and 2015. The investigators reported that in patients with chronic plantar fasciitis, 40.5%-60% had reduction in heel pain, 41.3%-60.8% had improvement in morning heel pain, and 49.6%-60% had improvement in heel pain during daily activities [43].

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Extracorporeal Shockwave Therapy

801 Table 3 802 Upper extremity studies characterizing effects of shockwave on management by condition: Rotator cuff tendonitis 803 Minimum No. of 804 805 Study No. of Subject Duration of Shockwave Type of Impulses/ Sessions; 806 Author Design Subjects Population Symptoms Device Shock Frequency EFD Interval Local Anesthesia 807 808 3; monthly No Speed RCT 74 Nonathletes 3 mo Sonocur FWST 1500 0.12 mL/mm2 809 2002 Plus pulses 810 Ioppolo RCT 46 Nonathletes 4 mo Modulith FWST 2400 0.20 or 4; weekly No, patients took 811 2 2012 SLK pulses 0.10 mJ/mm NSAID 1 h prior 812 to treatment 813 814 815 Galasso RCT 20 Nonathletes 4 mo Modulith FWST 3000 0.068 mJ/mm2 2; weekly Yes 816 2012 SLK pulses 817 818 819 Li 2017 RCT 84 Nonathletes 6 mo Sonothera RWST 3000 0.11 mJ/mm2, 5; 3 d Not specified 820 pulses 3 bar 821 822 823 Q6 EFD ¼ electron flux density; RCT ¼ randomized controlled trial; FWST ¼ ---; RWST ¼ ---; SPADI ¼ Shoulder Pain and Disability Index; NSAID ¼ nonsteroidal anti-inflammatory drug; CMS ¼ Constant-Murley Score; VAS ¼ visual analog scale; NRS ¼ numeric rating scale; ROM ¼ range 824 825 of motion; SST ¼ Simple Shoulder Test; ESWT ¼ extracorporeal shockwave therapy. 826 827 828 829 greater improvement in pain and function as compared Achilles tendinopathy 830 to eccentric loading alone at 4 months, though the groups 831 832 had similar outcomes at a 1-year follow-up [48]. Several studies have been conducted to evaluate the 833 In 2015, a systematic review was conducted on 11 effectiveness of ESWT in treating Achilles tendinopathy. 834 835 studies evaluating the use of ESWT for Achilles tendinAn initial study using focused ESWT delivered once 836 opathy. The authors concluded that ESWT demonstrated monthly for 3 sessions did not detect differences in 837 best evidence for short-term pain reduction and outcome [44]. Subsequent studies providing treatment 838 839 improved function compared to nonoperative treatment on a weekly basis demonstrated favorable results. Ras840 [49]. Of the studies included, 1 RCT found no difference mussen et al [45] assessed 48 patients with Achilles 841 842 between treatment arms [44]; however, the authors of tendinopathy for greater than 12 weeks and randomized 843 the review note that the subject population had an them to treatment with stretching and eccentric exer844 845 average age that was 10 years older on average for the cises and sham ESWT or ESWT. The intervention group 846 ESWT group compared to the conservative group, and received 4 weekly sessions of 2000 pulses (0.12-0.51 847 2 that this may have affected outcomes [49]. mJ/mm ) radial shock waves. The primary outcomes 848 849 measured included VAS for pain and American Ortho850 Patellar Tendinopathy paedic Foot and Ankle Society Score (AOFAS). The pa851 852 tients were followed at intervals of 4, 8, and 12 weeks. 853 In 2007, Vulpiani et al [12] performed a prospective Investigators reported a statistically significant increase 854 study in 73 patients with patellar tendinopathy, conin the AOFAS score of the intervention group, with best 855 856 sisting of treatment with an average of 4 weekly sesresults measured at 8 and 12 weeks. Both groups re857 sions of 1,500-2,500 impulses with energy varying from ported reduced pain; however, these differences were 858 859 0.08-0.41 mJ/mm2 adjusted to pain tolerance. At the not statistically significant. 860 Rompe conducted 2 studies assigning eccentric loading 1-month follow-up interval, 43.4% were found to 861 for the control group. For insertional Achilles tendinopbenefit, 63.9% at 6-12 months, 68.8% at 13-24 months, 862 863 athy, the control group was assigned the Alfredson proand finally 79.7% at >24 months as defined by a scale 864 tocol and compared to ESWT monotherapy. Superior pain created by the authors incorporating both improvement 865 866 relief and functional outcome with Victorian Institute of in pain on VAS and clinical improvement [12]. 867 Sports Assessment (VISA-A) was measured for the ESWT Zwerver et al [50] conducted an RCT to assess the 868 869 group [46], although the eccentric group did have efficacy of ESWT in treating patellar tendinopathy in 870 improvement in symptoms. Notably, the eccentric athletes who were actively competing, and found no 871 loading program did not use the modified Alfredson probenefit in this population with symptom duration less 872 873 tocol as it had not yet been described at the time of the than 12 months. The patients received 3 weekly sessions 874 study [47]. In a separate study, Rompe et al [48] of 2000 impulses with an EFD uptitrated to a maximum 875 876 compared subjects with midportion Achilles tendinoppossible level of 0.58 mJ/mm2. The control group 877 athy randomized to ESWT plus eccentric loading to subreceived the same treatment, with the exception that no 878 jects who were assigned eccentric loading. ESWT applicator gel was placed. The primary outcome, as 879 880 combined with eccentric loading was found to yield measured by the Victorian Institute of Sport

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Table 3 Continued Area Applied

Adjuvant Treatment

Ultrasound guidance, None maximal tenderness Not specified Not mentioned

Landmark, ultrasound guidance

Not specified

Follow-up

Primary Outcomes

1, 2, 3, >50% reduction in and 6 mo pain 3, 6, 12 mo Change in CMS at after 3 and 6 mo intervention

No pain 6, 12 wk medications 3 d prior to CMS evaluation Not specified 4, 8 wk after treatment

Secondary Outcomes

Results

No significant difference, both groups compared to baseline Pain on VAS, At 6 mo, higher-energy group had radiographic size significant improvement over lowerof calcium deposits, energy group in VAS scores and CMSs, Pain on NRS and quicker improvement Improvement of CMS, physical exam At 3 mo, mean relative improvement in >30 points or CMS total CMS, CMS pain, and ROM was >80% standard at significantly improved in treatment follow-up group compared to control Pain on NRS CMS, SST, adverse ESWT significantly improved pain and events shoulder function at both time points

AssessmentePatella (VISA-P) score, improved in both the control and treatment groups, and no significant difference between the groups was found at 1, 12, and 22 weeks. As opposed to the treatment protocol by Vulpiani, these athletes continued to participate in sport at their usual level without limitations on training. The authors suggest that ESWT is more effective in treating chronic patellar tendinopathy as opposed to the early stages of the disease process; however, they did not combine ESWT with standard conservative treatment, including eccentric loading. Additionally, the ESWT subjects were treated with energy levels exceeding the threshold that has been documented to contribute to tendon damage in animal model investigation [20]. In 2015, Mani-Babu et al [49] conducted a systematic review to evaluate the effectiveness of ESWT in treating patellar tendinopathy. The review included 5 studies consisting of 2 RCTs, 2 prospective trials and 1 retrospective trial. Overall, the results largely supported ESWT as a promising option for both short- and longterm treatment success [49]. A recent systematic review analyzed both surgical and nonsurgical treatment options available for treating patellar tendinopathy [51]. The authors concluded that treatment with ESWT should be considered following 6 months of nonsurgical treatment with eccentric exercises and physical therapy; however, ESWT may be considered for patients who are no longer progressing in physical therapy or those who do not want/or are determined to be poor surgical candidates [51]. Hamstring Tendinopathy One published study to date has been conducted in ESWT for high hamstring tendinopathy and demonstrated favorable results. Cacchio et al [13] evaluated 40 patients with MRI-verified chronic proximal hamstring

SPADI, night pain

tendinopathy and randomized (N¼20 each group) each to ESWT or conservative treatment. Shockwaves were administered for 4 sessions at weekly intervals, of 2500 shocks with EFD of 0.18 mJ/mm2. The traditional conservative treatment group was treated with NSAIDs, followed by physical therapy, and finally an exercise program for a total of 6 weeks. The primary outcomes were a 3-point decrease on VAS score and a 2-phase decrease in the Nirschl phase rating scale evaluated at 1 week, 6 months, and 12 months after treatment. A larger reduction in both outcomes measures was observed at all time points for ESWT over conservative care. Of clinical relevance, 80% of the ESWT group could return to their pre-injury level of sport, as opposed to zero of the patients from conservative care. No major complications were reported in the ESWT group. Greater Trochanteric Pain Syndrome (GTPS) Furia et al [14] published a retrospective cohort study in 2009 examining 36 patients diagnosed with GTPS and symptoms for an average duration of 13.7 months. Each patient received a single session of 2000 shocks at 0.18 mJ/mm2. The primary outcome was measured using VAS scores, Harris Hip Scores, and Roles-Maudsley scores at 1, 3, and 12 months post-treatment. At each interval, subjects reported a statistically significant improvement in all outcome measures [14]. Rompe et al [15] compared ESWT to corticosteroid injections and a home training program in patients with GTPS. Although a single palpation-guided corticosteroid injection targeting the greater trochanteric bursa and other painful regions yielded significantly better pain control at 1 month after intervention compared with ESWT and home training program, ESWT produced significantly better results at 4 months and 15 months after intervention [15].

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Extracorporeal Shockwave Therapy

1121 Table 4 1122 Lower extremity studies characterizing effects of shockwave on management by condition: Plantar fasciitis 1123 Minimum No. of 1124 Study No. of Subject Duration of Shockwave Type of Impulses/ Sessions; Local 1125 Author Design Subjects Population Symptoms Device Shock Frequency EFD Interval Anesthesia Area Applied 1126 1127 Rompe Prospective 30 Nonathletes 12 mo Siemens FWST 1000 pulses 0.06 3; weekly Not specified Landmark, 1128 1996 Cohort Osteostar mJ/mm2 fluoroscopyd 1129 at heel spur 1130 and 3 points 1131 arounds 1132 Buchbinder RCT 166 Nonathletes 6 wk Dornier Epos FWST 2000-2500 0.02-0.33 3; weekly Not specified Landmark, 1133 2002 Ultra pulses mJ/mm2 ultrasound 1134 guidance 1135 1136 1137 1138 1139 Haake 2003 RCT 272 Nonathletes 6 mo Dornier Epos FWST 4000 pulses 0.08 3; 2 wk Yes Landmark, 1140 Ultra mJ/mm2 ultrasound 1141 EFDþ guidance 1142 1143 1144 1145 Speed 2003 RCT 88 Nonathletes 3 mo Sonocur Plus FWST 1500 pulses 0.12 3; monthly No Ultrasound 1146 Siemens mJ/mm2 guidance, 1147 maximal 1148 tenderness 1149 Maximal Rompe RCT 86 Nonathletes 6 mo Sonocur FWST 2000 pulses, 0.09 3; weekly With and 1150 tenderness 2005 Siemens 4 Hz mJ/mm2 without 1151 anesthesia 1152 1153 1154 1155 1156 1157 Variable, Kudo 2006 RCT 114 Nonathletes 6 mo Dornier Epos FWST 3800  10 Maximal 1 Medical 1158 Total 2330 Ultra pulses, tenderness calcaneal 2 1159 mJ/mm variable nerve block 1160 frequency 1161 1162 1163 1164 0.25 Duolith SD1 FWST 500 Gollwitzer RCT 246 Nonathletes 6 mo, failed 3; weekly Per participant Maximal 1165 2 mJ/mm introductory 2015 nonsurgical request tenderness 1166 pulses, treatment 1167 followed by modalities 1168 2000 pulses, 1169 4 Hz 1170 1171 1172 1173 1174 1175 1176 Rompe RCT 152 Nonathletes 12 mo, failed EMS Electro- RWST 2000 pulses, Maximal Total EFD 320 3; weekly No 1177 2015 3 other tenderness Medical 8 Hz mJ/mm2/ 1178 treatment, forms Systems 1179 0.16 mJ/ treatment 1180 mm2 þEFD 1181 1182 1183 1184 1185 Q7 EFD ¼ electron flux density; RCT ¼ randomized controlled trial; FWST ¼ ---; RWST ¼ ---; VAS ¼ visual analog scale; SF-36 ¼ 36-Item Short 1186 Form Health Survey; ESWT ¼ extracorporeal shockwave therapy; RM ¼ Roles-Maudsley; NRS ¼ numeric rating scale; AOFAS ¼ American 1187 Orthopaedic Foot and Ankle Score; LA ¼ ---; SF-12 ¼ 12-Item Short Form Health Survey. 1188 1189 1190 1191 Medial Tibial Stress Syndrome the side effects and cost, 49 of 127 subjects chose 1192 treatment with radial shockwave and a home training 1193 1194 Rompe et al [52] conducted a case-control study program, and of the remaining 78 subjects who chose 1195 consisting of patients with medial tibial stress syndrome the home training program alone, 47 were selected as 1196 1197 (MTSS) who were offered treatment with radial ESWT. controls by a blinded medical assistant. Each shockwave 1198 All patients had symptoms for longer than 6 months and subject received 3 weekly low-energy treatments (EFD 1199 had imaging to exclude fracture. After being explained 0.1 mJ/mm2, total EFD 200 mJ/mm2). The severity of 1200

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Table 4 Continued

Adjuvant Treatment

Follow-up

Primary Outcome Measures

Secondary Outcome Measures

Results

No other treatments/drugs 6 wk before or during ESWT

3, 6, 12, 24 wk after last application

Night pain, resting pain, pressure pain on VAS

Pain-free plantar pressure, walking ability without need to rest

Significant improvement in pain and function at all follow-ups in treatment group

Allowed to continue prior orthotics/splints, no other treatment

6 and 12 wk after completion

Overall pain on VAS at 12 wk

No significant benefit in ESWT group as compared to control in all outcomes

No additional treatment prior to 12 wk, after 12 wk able to receive other treatment

6, 12 wk, 1 y after RM score at 12 wk postlast treatment treatment, Success defined as RM score of 1 or 2 and if patient received no additional treatment at 12 wk 1, 4 mo from base- Positive response, 50% improveline (1 mo after ment VAS foot pain during completion) day and night, start-up pain

VAS paineoverall, morning, activity; walking ability without need to rest; Maryland Foot Score; Problem Elicitation Technique (PET); SF-36; success of blinding Pain on NRS, walking ability, need for additional treatments for 1 y after last intervention

None

No significant benefit in ESWT group as compared to control in all outcomes

Number of patients with >50% improvement in pain NRS during first steps, number of patients >80 patients on AOFAS, number of patients with >50% improvement on subjective 4-point rating scale Change in AOFAS, RM score, SF12, pain on palpation, Clinical success as defined by >60% pain reduction

Significantly improved NRS in ESWT without LA as compared to ESWT and LA (P < .001)

No other treatments allowed

Reduction in pain at 3 mo on NRS for pain during first steps

No other treatments/ medications during treatment/follow-up. Pain rescue medication allowed

3 wk, 3, 12 mo after last application

Not specified

3-5 d, 6 wk, 3 mo Pain with first few minutes of walking on VAS at 3 mo post-treatment. 6, 12 mo in ESWT group

No other therapies. Could use 12 wk, 12 mo 2 g acetaminophen/d during study up to 14 d after last intervention, then could use 2 g/wk

Percentage change composite VAS heel pain, RM score at 12 wk post-treatment, pressure pain tolerance on VAS

Subjective effectiveness as graded by investigator, rates of success: >60% pain reduction in single VAS, overall success >60% pain reduction in 2/3 VAS measurements, RM success: excellent or good, analgesic requirement, patient satisfaction

2, 4, 24 mo Asked to not partake in PT, after baseline received heel pads. Could take NSAID if necessary. Asked to return to recreational activity at 4 wk. Treatment group received instructions on plantarfascia stretching program.

Mean change in Foot Function Index score at 8 wk, pain during first morning steps, satisfaction with treatment on patient relevant outcome measure

Not specified

pain as measured by a numeric rating scale was found to be significantly improved in the ESWT cohort at 1, 4, and 15 months. Fifteen months after treatment, 40 of the 47 patients in the ESWT group were able to return to their sport. In contrast, 22 of the 47 in the control group returned to sport. Additionally, patients in the ESWT group were more likely to state that they felt

Comparable improvement between groups, no statistically significant difference

Significant improvement in morning pain first steps P < .0001 in active compared to placebo, 25/43 (47%) in ESWT and 12/52 (23%) placebo met clinical success (P ¼ .0099). Significant improvement in RM score P ¼.0121, pain on palpation (P ¼.0027) ESWT significantly more effective at reducing heel pain on median composite score VAS (P ¼ .0027), and improving RM score (P ¼ .0006). Patient satisfaction, heel pain overall success rate, investigator effectiveness, and single VAS success rate for heel pain were significantly improved in the ESWT group. At 12 mo follow-up, treatment success persisted ESWT and stretching yielded significantly improved scores on Foot Function Index (P < .001), morning pain (P < .001), and patient satisfaction (P < .001) at 2 mo. Differences remained significant at 4 mo, not at 24 mo

“completely recovered” or “much improved” at all 3 time points. In 2012, Moen et al [33] conducted a prospective control study of athletes with MTSS who were treated with either a running program or focused shockwave in combination with a running program. Five focused shockwave sessions were performed at weeks 1, 2, 3, 5,

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Extracorporeal Shockwave Therapy

1441 Table 5 1442 Lower extremity studies characterizing effects of shockwave on management by condition: Achilles tendinopathy 1443 Minimum No. of 1444 1445 Study No. of Subject Duration of Shockwave Type of Impulses/ Sessions; Local 1446 Author Design Subjects Population Symptoms Device Shock Frequency EFD Interval Anesthesia 1447 1448 3; monthly No Costa 2005 RCT 49 Nonathletes 4 mo Storz FWST 1500 pulses Max 0.2 1449 Modulith mJ/mm2 1450 SLK 1451 1452 1453 4; weekly No Rasmussen RCT 48 Nonathletes 3 mo Piezoson FWST 2000 pulses, 0.12-0.51 1454 1455 2008 100 50 Hz mJ/mm2, 1456 placebo: 1457 0 mJ/mm2 1458 Rompe RCT 50 Nonathletes 6 mo EMS Swiss RWST 2000 pulses, 0.12 3; weekly No 1459 2008 Dolorclast 8 Hz mJ/mm2, 1460 2.5 bar 1461 1462 1463 1464 1465 1466 Rompe RCT 68 Nonathletes 6 mo EMS Swiss RWST 2000 pulses, 0.1 mJ/mm2 3; weekly No 1467 1468 2009 Dolorclast 8 Hz 1469 1470 1471 1472 1473 1474 1475 1476 1477 Wu 2016 Retrospective 67 Nonathletes 6 mo EMS Swiss RWST 2000 pulses, 0.12 5; weekly No 1478 2 cohort Dolorclast 8 Hz mJ/mm 1479 1480 1481 1482 1483 1484 1485 1486 Q8 EFD ¼ electron flux density; RCT ¼ randomized controlled trial; FWST ¼ ---; RWST ¼ ; VAS ¼ visual analog scale; ROM ¼ range of motion; FIL ¼ 1487 Functional Index of Lower Limb Activity; EQoL ¼ EuroQol Generalized Health Status Questionnaire; AOFAS ¼ American Orthopaedic Foot and Ankle 1488 Score; ESWT ¼ extracorporeal shockwave therapy; NSAIDs ¼ nonsteroidal anti-inflammatory drugs; VISA-A ¼ Victorian Institute of Sports 1489 Assessment; NRS ¼ numeric rating scale. 1490 1491 1492 and 9, with the first session consisting of 1000 shocks till full recovery in the ESWT group was 59.7 days 1493 with an EFD of 0.10 mJ/mm2, and the last session with compared to 91.6 in the running program control 1494 1495 1500 shocks with an EFD of 0.30 mJ/mm2. The duration group. 1496 1497 Table 6 1498 Lower extremity studies characterizing effects of shockwave on management by condition: Patellar tendinopathy 1499 1500 Minimum No. of 1501 Study No. of Subject Duration of Shockwave Type of Impulses/ Sessions; Local 1502 Author Design Subjects Population Symptoms Device Shock Frequency EFD Interval Anesthesia 1503 1504 Average 4; No Vulpiani 3 mo Storz FWST 1500-2500 0.08-0.44 Prospective 73 Athletes: 1505 2-7 d 2007 cohort 13 professional, Medical pulses mJ/mm2 1506 41 amateur, 1507 19 weekly 1508 1509 1510 Zwerver RCT 62 Athletes 3-12 mo Piezowave FWST 2000 pulses, Variable, 3; weekly No 1511 2011 4 Hz maximum 1512 0.58 mJ/mm2 1513 1514 1515 1516 1517 1518 1519 Q9 EFD ¼ electron flux density; FWST ¼ ---; RCT ¼ randomized controlled trial; VAS ¼ visual analog scale; VISA-P ¼ ---; VAS ¼ visual analog 1520 scale; ADLs ¼ activities of daily living.

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Table 5 Continued Area Applied

Primary Outcome Measures

Secondary Outcome Measures

4 wk

VAS score pain on walking

Stretching, eccentric training prior to ESWT, sham

4, 8, 12 wk after completion

AOFAS score

VAS pain at rest and during activity, ankle ROM, calf muscle circumference, tendon diameter, FIL, EQoL VAS pain on walking, stairs, working, running

Control: eccentric training per protocol with heel drop past neutral. Could take NSAIDs if necessary. All patients instructed to avoid painful activity, could lightly jog at 4 wk Treatment groups ¼ ESWT with eccentric training per protocol. Could take NSAIDs if necessary. All patients instructed to avoid painful activity, could lightly jog at 4 wk. All cointerventions discouraged Not specified

12, 16 wk, 15 mo, after ESWT

Not specified VISA-A, general subjective outcome epatient, pain on NRS, pressure pain threshold, use of analgesics Not specified VISA-A, General subjective outcome epatient, pain on NRS

ESWT had significantly improved outcome measures over conservative group on subjective assessment, pain, pain threshold, tenderness. No significant difference on VISA-A. At 4 mo, ESWT þ eccentric loading had significantly better outcomes on VISA-A (P ¼ .0016), general assessment (P ¼ .001), pain (P ¼ .0045)

Not specified

At the follow-up time point, nondeformity group had significantly improved VISA-A compared to deformity group. No difference in patient-graded outcomes on Likert scale P ¼ .062

Adjuvant Treatment

Follow-up

Ultrasound guidance, maximal tenderness

Not mentioned

Maximal tenderness

Maximal tenderness, clinical focusing technique

Maximal tenderness, clinical focusing technique

Maximal tenderness, clinical focusing technique

4 mo

VISA-A, 6-point Average 14.5 Likert scale: and 15.3 mo success if with absence and presence patients rate themselves as of Haglund’s 1 or 2, failure deformity, if 3-6 respectively

Additionally, there are notable case reports of success in treatment of MTSS in high-level athletes. Saxena et al [53] described treatment of 2 elite athletes

Results No significant difference between groups

ESWT significantly more effective at 8 (P ¼ .01) and 12 wk (P ¼ .04)

diagnosed with MTSS, who were treated with ESWT and a graduated running protocol. The cases describe athletes who were able to continue participating in their

Table 6 Continued

Area Applied Adjuvant Treatment

Follow-up

Not specified Patients asked not to return to sports for minimum 3 wk. No other treatment

1 mo after completion, 6-12 mo, 13-24 mo, >24 mo 1, 12, 22 wk after final treatment

Maximal No restriction on sports tenderness participations or concurrent treatment. Could take acetaminophen 3000 mg/qD for 2 d after treatment

Primary Outcome Measures

Secondary Outcome Measures

Results

Average VAS Not mentioned Significant improvement in pain (P < .01) pain, at 1 mo, further improving towards 24 subjective mo after treatment. Satisfactory clinical results in 79.7% of patients at final evaluation evaluation VISA-P VAS during ADLs and No significant difference between sports, after groups in VISA-P or VAS, no treatmentperforming functional time interaction effect. Only tests, maximal jumping significant difference was subjective test, triple-hop test, pain improvement 1 wk after final single-legged decline treatment in VAS squat

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Extracorporeal Shockwave Therapy

1761 Table 7 1762 Lower extremity studies characterizing effects of shockwave on management by condition: Hamstring tendinopathy 1763 Minimum 1764 Study No. of Subject Duration of Shockwave Type of Impulses/ No. of Sessions; Local 1765 Author Design Subjects Population Symptoms Device Shock Frequency EFD Interval Anesthesia 1766 1767 Cacchio 2011 RCT 40 Professional 11 mo EMS Swiss RWST 2500 pulses, 10 Hz 0.18 mJ/mm2, 4; weekly No 1768 Athletes Dolorclast 4 bar 1769 1770 1771 1772 1773 1774 1775 1776 1777 Q10 EFD ¼ electron flux density; RCT ¼ randomized controlled trial; RWST ¼ ---; ROM ¼ range of motion; NSAIDs ¼ nonsteroidal anti-inflammatory drugs; PT ¼ physical therapy; VAS ¼ visual analog scale; NPRS ¼ Nirschl Phase Rating Scale; ESWT ¼ extracorporeal shockwave therapy; SWT ¼ 1778 1779 shockwave therapy. 1780 1781 1782 sports safely, and in one case, one won an Olympic Gold Wang et al [58] studied ESWT versus core decom1783 Medal 17 weeks after treatment [53]. pression and grafting in patients with avascular necrosis 1784 1785 of the femoral head. Twenty-five months after treat1786 ment, patients treated with ESWT had improved pain and 1787 1788 Harris Hip Scores. At long-term follow-up, 76% of the Nonunions, Avascular Necrosis, Stress Fractures 1789 patients treated with ESWT showed good or fair clinical 1790 outcomes, compared with 21% of the surgical treatment Shockwave therapy for the treatment of conditions 1791 1792 group [59]. Taki et al [60] reported 5 cases in which ESWT such as nonunions, stress fractures, and avascular ne1793 was used to expedite healing in refractory stress fraccrosis appears to be more widely accepted outside of 1794 1795 ture, in which radiographic improvement was seen within the United States than within the United States [6]. 1796 1-1.5 months after treatment, and radiographic consoliFuria et al [6] report that many trauma centers in 1797 dation between 1-3.5 months after treatment. Europe and Asia regularly use ESWT to treat nonunions. 1798 1799 Birnbaum et al [54] examined 10 studies and concluded 1800 that though ESWT yielded high healing rates, 75%-91%, Upper Extremity Pathology 1801 1802 this treatment was to remain considered “experi1803 mental” as there were no prospective RCTs. Efficacy Lateral Epicondylitis 1804 1805 appears to depend on the type of bone-related pathol1806 ogy, differentiating between nonunion, atrophy, or hyInitial studies on the effect of ESWT for management 1807 pertrophy [55,56]. Cacchio et al [57] published a of lateral epicondylitis found little benefit over pla1808 1809 prospective RCT that compared ESWT in treatment of cebo treatment [8,9,61-63]. Some issues with these 1810 long-bone nonunions to surgical treatment. ESWT was studies include use of local anesthesia [63], monthly 1811 1812 found to be comparable to surgery in healing long-bone frequency of treatments with a short follow-up of 1813 nonunions. ESWT may be an effective treatment for 3 months [9], low-dose ESWT as control treatment 1814 nonunion, [61], and inadequate description in chronicity of but optimal dose and protocol must still be 1815 1816 symptoms [8]. established. 1817 1818 1819 Table 8 1820 Lower extremity studies characterizing effects of shockwave on management by condition: Greater trochanteric pain syndrome 1821 1822 No. of Minimum 1823 Sessions; Local Duration of Shockwave Type of Impulses/ Study No. of 1824 Interval Anesthesia Symptoms Device Shock Frequency EFD Author Design Subjects Subject Population 1825 2 6 mo EMS Swiss RWST 2000 pulses, 0.18 mJ/mm , 1 Furia 2009 Case 33 Mix of athletes/nonathletes: No 1826 1827 Dolorclast 10Hz Control 52% ESWT recreational 4 bar 1828 athletes, 45% control 1829 recreational athletes 1830 1831 Rompe 2009 RCT 229 Nonathletes 6 mo EMS Swiss RWST 2000 pulses, 0.12 mJ/mm2, 3; weekly No 1832 Dolorclast 8Hz 3 bar 1833 1834 1835 1836 1837 1838 Q11 EFD ¼ electron flux density; ESWT ¼ extracorporeal shockwave therapy; RWST ¼ ---; RCT ¼ randomized controlled trial; VAS ¼ visual analog 1839 scale; RM ¼ Roles-Maudsley. 1840

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Table 7 Continued

Area Applied

Adjuvant Treatment

Follow-up

Primary Outcome Measures

Secondary Outcome Measures

Results

Maximal tenderness, Unrestricted ROM and weightbearing 1 wk, 3, 6, 12 mo Decrease of 3 points in Degree of subjective Significant improvement in ESWT clinical focusing after treatments, recommended after completion mean pain VAS at recovery on 6-point as compared to conservative technique ice after treatment for 4 hours the 3-mo follow-up, Likert scale group at 3 mo VAS (P < .001), after. Patients instructed to avoid 2-phase decrease NPRS (P < .001). Eighty percent activities/exercises that would in NPRS in SWT group returned to increase severity of symptoms. professional level of their Control: NSAIDs, PT, exercise sport vs 0% in traditional program group

In contrast, 2 studies have revealed a favorable response of ESWT for lateral epicondylitis. Pettrone and McCall [64] studied 114 patients with chronic lateral epicondylitis, as defined by symptoms for at least 6 months and failure of 2 conservative therapy treatments. The patients were randomized to receive ESWT for 3 weekly treatments (2000 impulses, EFD 0.06 mJ/mm2) or sham treatment with a sound-reflecting pad between the head of the machine and the patient. At 12 weeks, patients in the placebo group could cross over into the active treatment group if they still met study criteria. At 12 weeks, there was a significant difference in pain reduction on the Thomsen test and on the VAS. There was a significant improvement in the upper extremity functional scores and patient activity scores in the treatment group at 12 weeks. Additionally, there was an improvement in grip strength in the treatment group, but this difference was not found to be significant (P ¼ .09). At 1 year, 93% of the active treatment group reported at least 50% reduction in pain. Patients who chose to cross over to ESWT had observed improved pain scores compared to their prior pain scores during placebo treatment. The benefits in pain reduction were durable for nearly all who received ESWT over 12 months’ follow-up [64]. Similarly Rompe et al [65] performed an RCT examining the effect of 3 weekly sessions

of low-dose ESWT (0.09 mJ/mm2) versus placebo for treatment of chronic lateral epicondylitis, with the primary outcome of improved pain during the Thomsen test at 3 months. Though reduced pain was noted in both groups 3 months after completion of treatment, the ESWT group was found to have statistically significant improvement compared with the control group (95% CI 0.6-2.5; P ¼ .0001). Twelve months post-treatment, the difference in pain reduction between groups persisted, and remained significant (95% CI 0.2-2.3, P ¼ .019). In 2007, Rompe and Maffuli [66] conducted a systematic review of 10 studies that evaluated ESWT as treatment for lateral epicondylitis. Because of the clinical and methodologic heterogeneity, the results of the studies were not pooled for meta-analysis. The authors concluded that ESWT could be considered in restricted conditions only, and might yield improved outcomes in chronic recalcitrant cases. Tendinopathy of the Shoulder The first reported study on noncalcific rotator cuff tendinopathy was by Speed et al [10]. Investigators compared active ESWT delivered with an EFD of 0.12 mJ/mm2 to sham treatment (0.04 mJ/mm2, head

Table 8 Continued Area Applied

Adjuvant Treatment

Follow-up

Primary Outcome Measures

Secondary Outcome Measures

Results

Not specified ESWT yielded significantly 1, 3, 12 mo after VAS score, Harris Hip Score Maximal tenderness, Concomitant treatment improved outcomes at all treatment (HHS), RM score. Two-point discouraged. Stationary clinical focusing time points compared to change on VAS, 10-point cycling permitted technique placebo change on HHS considered immediately, light clinically relevant running at 1 wk ESWT significantly more effective Degree of recovery and Maximal tenderness, Could return to prior 1, 4, 15 mo after Degree of recovery at 4 mo than home training and steroid severity of pain at 1 mo, clinical focusing recreational activity treatment on 6-point Likert scale, at 4 mo, ESWT equal to home 15 mo; use of medication, technique after 6 wk severity of pain on VAS training and better than medical visits, diagnostic score corticosteroid injection at 15 mo tests, side effects, return to activity

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2081 Table 9 2082 Lower extremity studies characterizing effects of shockwave on management by condition: Medial tibial stress syndrome 2083 Minimum 2084 2085 No. of Subject Duration of Shockwave Type of Impulses/ No. of Local 2086 Author Study Design Subjects Population Symptoms Device Shock Frequency EFD Sessions Anesthesia 2087 2088 Rompe 2010 Case-control 94 Athletese 6 mo, failed 3 EMS Swiss RWST 2000 pulses, 0.10 mJ/mm2, 3; weekly No 2089 2 bar running nonsurgical Dolorclast 8Hz 2090 treatments 2091 2092 2093 2094 2095 2096 2097 2098 5; 1, 2, 3, Not Moen 2012 Prospective 42 Athletes 21 d Duolith SD1 FSWT 1000-1500 pulses, 0.10-0.30 2099 5, 9 wk specified control 2.5 Hz mJ/mm2 2100 2101 2102 2103 2104 2105 Q12 EFD ¼ electron flux density; RCT ¼ randomized controlled trial; FWST ¼ ---; RWST ¼ ---; NSAIDs ¼ nonsteroidal anti-inflammatory drugs; 2106 NRS ¼ numeric rating scale; ESWT ¼ extracorporeal shockwave therapy. 2107 2108 2109 deflated without coupling gel) for 3 treatments proeach separated by 3 days. The outcomes were measured 2110 vided monthly. Both groups had improvements over 6 at 4 and 8 weeks after treatment, at which time all 2111 2112 months, with investigators concluding that placebo measures, pain by numeric rating scale, Constant2113 benefits were seen in the use of ESWT for this condition Murley Score (CMS), and Simple Shoulder Test, were 2114 2115 [10]. Li et al [67] conducted a randomized, doublesignificantly improved in the ESWT group over the con2116 blind, placebo-controlled trial examining patients with trol group [67]. Galasso et al [68] performed a double2117 2118 chronic rotator cuff tendinitis without calcifications blind, randomized, placebo-controlled study on 20 pa2119 with symptoms for greater than 6 months. The intertients with noncalcifying supraspinatus tendinopathy 2120 vention was 3000 pulses of radial shockwave and EFD of and found significantly improved CMS and ROM in the 2121 2122 0.11 mJ/mm2. Five total treatments were provided with ESWT group as compared to the placebo group. 2123 2124 2125 Table 10 2126 Lower extremity studies characterizing effects of shockwave on management by condition: Nonunion, Avascular Necrosis, Stress Fractures 2127 2128 Minimum No. of 2129 Study No. of Subject Duration of Shockwave Type of Impulses/ Sessions; Local 2130 Author Design Subjects Population Symptoms Device Shock Frequency EFD Interval Anesthesia 2131 2132 FWST 4000 pulses Group 1: Cacchio RCT 126 Nonathletes 6 mo Group I: 4; weekly Regional 2133 2009 Dornier 0.40 mJ/mm2, anesthesiad 2134 Epos Ultra, nerve block Group 2: 2 2135 Group 2: 0.70 mJ/mm 2136 Modulith 2137 SLK 2138 2139 2140 2141 2142 Xu 2009 Retrospective 69: 22 femur, Nonathletes 6 mo Ossatron FWST 3000-10 000 0.56-0.62 Unclear; Spinal or 2143 2144 cohort 28 tibia, pulses based mJ/mm2 unclear local 2145 13 humerus, on location based on anesthesia 2146 5 radius, of fracture location 2147 1 ulna 2148 2149 Wang RCT 49 Nonathletes Minimum not Ossatron FWST 6000-1500 0.62 mJ/mm2 1 General 2150 2005 reported, pulses anesthesia 2151 average 5.9 in 4 points 2152 and 7.1 ESWT 2153 and core 2154 decompression, 2155 2156 respectively 2157 Q13 EFD ¼ electron flux density; RCT ¼ randomized controlled trial; FWST ¼ ---; RWST ¼ ---; ESWT ¼ extracorporeal shockwave therapy; 2158 NSAIDs ¼ nonsteroidal anti-inflammatory drugs; DASH ¼ Disabilities of the Arm, Shoulder, and Hand; LEFS ¼ ---; VAS ¼ visual analog scale; 2159 2160 PRN ¼ pro re nata (on an as needed basis); ADL ¼ activity of daily living; MRI ¼ magnetic resonance imaging

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Table 9 Continued Primary Outcome Measures

Secondary Outcome Measures

1, 4, 15 mo from baseline

Degree at recovery at 4 mo on 6-point Likert scale

Degree at recovery at 1 and 15 mo, severity of pain during past week on NRS, current sports activities

ESWT with home training yielded significantly improved results in success rates and pain at all time points. 40/47 patients returned to their sport at 15 mo in ESWT group compared to 22/47 in control

Unclear

Number of days from inclusion to completion of phase 6 (full recovery) of running program

If full recovery not reached, Likert scale used to assess recovery

Significantly faster recovery in ESWT þ running program as compared to running program alone (P ¼ .008)

Area Applied

Adjuvant Treatment

Follow-up

Maximal tenderness, clinical focusing technique

Concomitant treatment discouraged until the 4-mo follow-up. NSAIDs allowed when requested. After 6 wk, could return to prior level of sport/activity. Stationary cycling permitted immediately, light running at 1 wk Graded running program: 6-phase

Maximal tenderness

Ioppolo et al [69] studied patients with calcific tendinitis of the supraspinatus tendon. Forty-six patients were randomized to either receive 4 weekly sessions of ESWT using 2400 pulses at 0.20 or 0.10 mJ/mm2, and a control group was not present. The outcomes in terms of CMS and pain score on VAS were measured at 3 and 6 months after treatment. Interval change in radiographic appearance of calcific deposits was evaluated 6 months post-treatment. Both groups were found to have improved outcomes at each time point;

Results

however, the VAS scores were statistically reduced and the CMSs were higher at 6 months in the higher energy group (0.20 mJ/mm2). The authors also noted that clinical improvement did not correlate with a reduction in size of calcifications [69]. Bannuru et al [70] performed a systematic review examining 28 RCTs pooling 1745 patients with symptoms for 3-12 months. Patients with calcific and noncalcific tendinitis were included in this review. The authors found that high-energy ESWT (EFD > 0.28 mJ/mm2) was

Table 10 Continued

Area Applied

Adjuvant Treatment

Follow-up

Primary Outcome Measures

Secondary Outcome Measures Results

Center of fracture Limb immobilized 3, 6, 12, 24 mo Healing of nonunion gap on ultrasound in cast/brace for after treatment by radiographic guidance and prior 6 wke3 mo. NSAIDs assessment at 6 mo radiographs could be used once daily for 3 d after ESWT. Weightbearing could be resumed 3 d after ESWT.

DASH/LEFS, VAS, Subjective efficacy

C-arm

Not specified

C-arm

Avoidance of general activity for 1 wk, return to prior weight-bearing status 7 d after treatment Partial weightbearing for 6 wk, acetaminophen for pain

2, 3, 4, 6 mo and PRN after treatment

Radiographic callus formation/bony union

1, 3, 6, 12 mo, yearly

VAS pain, Harris Hip Not specified Score (HHS), assessment of ADL and work capacity, radiographic assessment by radiography and MRI

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At 6 mo, ESWT groups had significantly improved clinical outcomes compared to surgical group (P < .001). Radiograph to demonstrate healing showed no difference between groups. At 12 and 24 mo, no difference between groups aside from ESWT, with significantly improved DASH over surgical group ESWT was more successful in bony union for hypertrophic nonunions (90.9%) than for atrophic nonunions (0%). Total overall success 75.4% bony union At 25 mo follow-up, ESWT group had significantly improved VAS and HHS (P < .001).

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successful in improving pain, function, and resorption of calcifications in patients with calcific tendinitis. Lowenergy ESWT was found to improve shoulder function in patients with calcific tendinitis; however, ESWT for treatment of noncalcific tendinitis at both high and low energy was not effective. In 2017, Wu et al [71] examined 14 RCTs that evaluated several different treatment options for chronic calcific tendinitis of the shoulder, including high-energy FSWT, low-energy FSWT, radial shockwave, transcutaneous electrical nerve stimulation, and ultrasoundguided needling. They found that high-energy FSWT and radial shockwave were more effective than low-energy focused shockwave. Ultrasound-guided needling also appeared to produce beneficial results. Of all forms of ESWT, high-energy focused shockwave was found to be the best therapy for promoting functional recovery [71]. Adverse Effects of ESWT In all studies, common side effects after ESWT include transient pain, skin erythema, pain, and local swelling. Two case reports were found that noted bone injuries [72,73]. The first described a patient who received ESWT for supraspinatus calcific tendinopathy, who showed improvement clinically and radiographically after treatment. Three years after treatment, she developed recurrent shoulder pain and was diagnosed with stage IV osteonecrosis of the humeral head. The authors of the case report mention that injury to the ascending branch of the anterior humeral circumflex artery may explain her presentation [72]. The second case involves a patient treated for plantar fasciitis with 2 sessions of ESWT within 10 days. After treatment, she noted worsening pain and greater difficulty ambulating. Her MRI revealed a linear calcaneal fracture that did not reach the opposite cortex. Three months later the fracture healed, and 12 months later her pain resolved [73]. A separate study identified 2 patients receiving focused shockwave who sustained Achilles tendon ruptures; both occurred within 2 weeks of treatment and were in older female patients ages 62 and 65 [44]. Conclusion ESWT may result in beneficial effects for treatment of patients with various refractory musculoskeletal conditions including disease of tendons and plantar fascia. Notably, studies did have mixed results for most conditions, and studies with favorable outcomes did not report consistent improvement for all patients receiving ESWT. Individual response to ESWT likely varies based on a number of factors. The optimal protocol, including EFD, number of impulses, device, type of shockwave, number of treatment sessions, interval between sessions, and adjuvant treatment must still be determined for each condition. In patients who have failed to

respond adequately to conservative treatment options and are presented with surgery as the next choice, ESWT may be a reasonable alternative treatment option that could produce results comparable or superior to those with surgical treatment [57]. Available literature would support use of low-energy radial shockwave treatment for most treatment applications mentioned in this review; focused high-energy shockwave appears to be more effective for calcific tendinopathy of the shoulder. The number of treatments varied between protocols; however, most studies demonstrating efficacy separated treatment by 1 week and provided a total of 3-5 treatment sessions. Not all protocols reported on the combined use of physical therapy. Philosophically, coupling ESWT to progressive physical therapy programs to restore tissue function may optimize response to treatment. Nerve block is not recommended during treatment according to available literature demonstrating poor outcomes when using anesthetics. Additionally, use of local analgesia may reduce the ability to use the clinical focusing technique to interactively identify sites of pathology and direct treatment. Additionally, NSAID use may be discouraged given the concern for disrupting normal inflammatory pathway that may be responsible for treatment response. As physiatrists provide care to athletes and individuals with musculoskeletal and neurologic injuries, identifying effective treatments for pain is important to help facilitate function. Limitations in guiding use of ESWT include the small number of well-designed clinical trials to evaluate efficacy of treatment. Notably, few studies have evaluated athlete populations, and there are no recognized studies published to date in patients with underlying neurologic conditions or patients with non-musculoskeletal classes of disability. The studies evaluated in this review had low measured bias with exception of criteria of blinding the therapist administering placebo and treatment ESWT. Studies have created a variety of placebo ESWT conditions; however, the influence of not achieving complete blinding to comparative effectiveness cannot be determined. In addition to measures to optimize blinding of treatment, studies are needed to compare ESWT to other interventions for treatment of tendon and ligament diseases, including platelet-rich plasma, tenotomy, and other treatments. Postprocedure guidelines do not currently exist to guide patients on appropriate graded return to exercise for most conditions following ESWT. Additionally, medical insurance and healthcare delivery in the United States does not routinely reimburse for ESWT treatment, creating a financial barrier. Despite these limitations, the current evidence does suggest ESWT may be a reasonable treatment to consider for management of chronic musculoskeletal conditions that fail to respond to conservative care given favorable safety profile and low risk for side effects.

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References 1. Chaussy C, Schmiedt E, Jocham D, Brendel W, Forssmann B, Walther V. First clinical experience with extracorporeally induced destruction of kidney stones by shock waves. J Urol 1982;127:417-420. 2. Argyropoulos AN, Tolley DA. Optimizing shock wave lithotripsy in the 21st century. Eur Urol 2007;52:344-352. 3. Park SH, Park JB, Weinstein JN, Loening S. Application of extracorporeal shock wave lithotripter (ECSWL) in orthopedics. I. Foundations and overview. J Appl Biomater 1991;2:115-126. 4. Weinstein JN, Oster DM, Park JB, Park SH, Loening S. The effect of the extracorporeal shock wave lithotriptor on the bone-cement interface in dogs. Clin Orthop Relat Res 1988;235:261-267. 5. Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology 1992;39:529-532. 6. Furia JP, Rompe JD, Cacchio A, Maffulli N. Shock wave therapy as a treatment of nonunions, avascular necrosis, and delayed healing of stress fractures. Foot Ankle Clin 2010;15:651-662. 7. Rompe JD, Hopf C, Nafe B, Burger R. Low-energy extracorporeal shock wave therapy for painful heel: A prospective controlled single-blind study. Arch Orthop Trauma Surg 1996;115:75-79. 8. Melikyan EY, Shahin E, Miles J, Bainbridge LC. Extracorporeal shock-wave treatment for tennis elbow. A randomised doubleblind study. J Bone Joint Surg Br 2003;85:852-855. 9. Speed CA, Nichols D, Richards C, et al. Extracorporeal shock wave therapy for lateral epicondylitisdA double blind randomised controlled trial. J Orthop Res 2002;20:895-898. 10. Speed CA, Richards C, Nichols D, et al. Extracorporeal shock-wave therapy for tendonitis of the rotator cuff. A double-blind, randomised, controlled trial. J Bone Joint Surg Br 2002;84:509-512. 11. Furia JP. High-energy extracorporeal shock wave therapy as a treatment for insertional Achilles tendinopathy. Am J Sports Med 2006;34:733-740. 12. Vulpiani MC, Vetrano M, Savoia V, Di Pangrazio E, Trischitta D, Ferretti A. Jumper’s knee treatment with extracorporeal shock wave therapy: A long-term follow-up observational study. J Sports Med Phys Fitness 2007;47:323-328. 13. Cacchio A, Rompe JD, Furia JP, Susi P, Santilli V, De Paulis F. Shockwave therapy for the treatment of chronic proximal hamstring tendinopathy in professional athletes. Am J Sports Med 2011;39:146-153. 14. Furia JP, Rompe JD, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for greater trochanteric pain syndrome. Am J Sports Med 2009;37:1806-1813. 15. Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N. Home training, local corticosteroid injection, or radial shock wave therapy for greater trochanter pain syndrome. Am J Sports Med 2009;37:1981-1990. 16. Wang CJ. Extracorporeal shockwave therapy in musculoskeletal disorders. J Orthop Surg Res 2012;7:11. 17. van der Worp H, van den Akker-Scheek I, van Schie H, Zwerver J. ESWT for tendinopathy: Technology and clinical implications. Knee Surg Sports Traumatol Arthrosc 2013;21:1451-1458. 18. McClure S, Dorfmuller C. Extracorporeal shock wave therapy: Theory and equipment. Clin Tech Equine Pract 2003;2:348-357. 19. Ioppolo F, Rompe JD, Furia JP, Cacchio A. Clinical application of shock wave therapy (SWT) in musculoskeletal disorders. Eur J Phys Rehabil Med 2014;50:217-230. 20. Rompe JD, Kirkpatrick CJ, Kullmer K, Schwitalle M, Krischek O. Dose-related effects of shock waves on rabbit tendo Achillis. A sonographic and histological study. J Bone Joint Surg Br 1998;80: 546-552. 21. Wang CJ, Huang HY, Pai CH. Shock wave-enhanced neovascularization at the tendon-bone junction: An experiment in dogs. J Foot Ankle Surg 2002;41:16-22. 22. Chen YJ, Wang CJ, Yang KD, et al. Extracorporeal shock waves promote healing of collagenase-induced Achilles tendinitis and

23.

24.

25.

26. 27.

28.

29.

30.

31. 32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

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increase TGF-beta1 and IGF-I expression. J Orthop Res 2004;22: 854-861. Wang FS, Yang KD, Chen RF, Wang CJ, Sheen-Chen SM. Extracorporeal shock wave promotes growth and differentiation of bonemarrow stromal cells towards osteoprogenitors associated with induction of TGF-beta1. J Bone Joint Surg Br 2002;84:457-461. Bosch G, Lin YL, van Schie HT, van De Lest CH, Barneveld A, van Weeren PR. Effect of extracorporeal shock wave therapy on the biochemical composition and metabolic activity of tenocytes in normal tendinous structures in ponies. Equine Vet J 2007;39:226-231. Waugh CM, Morrissey D, Jones E, Riley GP, Langberg H, Screen HR. In vivo biological response to extracorporeal shockwave therapy in human tendinopathy. Eur Cell Mater 2015;29:268-280. discussion 280. Wess OJ. A neural model for chronic pain and pain relief by extracorporeal shock wave treatment. Urol Res 2008;36:327-334. Vahdatpour B, Alizadeh F, Moayednia A, Emadi M, Khorami MH, Haghdani S. Efficacy of extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome: A randomized, controlled trial. ISRN Urol 2013;2013:972601. Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: A randomised, double-blind, placebocontrolled study. Eur Urol 2009;56:418-424. Saggini R, Di Stefano A, Saggini A, Bellomo RG. Clinical application of shock wave therapy in musculoskeletal disorders: Part I. J Biol Regul Homeost Agents 2015;29:533-545. Klonschinski T, Ament SJ, Schlereth T, Rompe JD, Birklein F. Application of local anesthesia inhibits effects of low-energy extracorporeal shock wave treatment (ESWT) on nociceptors. Pain Med 2011;12:1532-1537. PEDro Scale [December 4, 2017]. https://www.pedro.org.au/ english/downloads/pedro-scale/. Dizon JN, Gonzalez-Suarez C, Zamora MT, Gambito ED. Effectiveness of extracorporeal shock wave therapy in chronic plantar fasciitis: A meta-analysis. Am J Phys Med Rehabil 2013;92:606-620. Moen MH, Rayer S, Schipper M, et al. Shockwave treatment for medial tibial stress syndrome in athletes; A prospective controlled study. Br J Sports Med 2012;46:253-257. Kudo P, Dainty K, Clarfield M, Coughlin L, Lavoie P, Lebrun C. Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: A North American confirmatory study. J Orthop Res 2006;24:115-123. Gollwitzer H, Saxena A, DiDomenico LA, et al. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: A randomized, controlled multicenter study. J Bone Joint Surg Am 2015;97:701-708. Rompe JD, Furia J, Cacchio A, Schmitz C, Maffulli N. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fasciastretching in patients with chronic plantar heel pain. Int J Surg 2015;24(pt B):135-142. Haake M, Buch M, Schoellner C, et al. Extracorporeal shock wave therapy for plantar fasciitis: Randomised controlled multicentre trial. BMJ 2003;327:75. Speed CA, Nichols D, Wies J, et al. Extracorporeal shock wave therapy for plantar fasciitis. A double blind randomised controlled trial. J Orthop Res 2003;21:937-940. Buchbinder R, Ptasznik R, Gordon J, Buchanan J, Prabaharan V, Forbes A. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: A randomized controlled trial. JAMA 2002;288: 1364-1372. Ogden JA. Extracorporeal shock wave therapy for plantar fasciitis: Randomised controlled multicentre trial. Br J Sports Med 2004;38:382. Rompe JD, Meurer A, Nafe B, Hofmann A, Gerdesmeyer L. Repetitive low-energy shock wave application without local

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Extracorporeal Shockwave Therapy

2721 anesthesia is more efficient than repetitive low-energy shock wave 2722 application with local anesthesia in the treatment of chronic 2723 plantar fasciitis. J Orthop Res 2005;23:931-941. 2724 42. Thomson CE, Crawford F, Murray GD. The effectiveness of 2725 2726 extra corporeal shock wave therapy for plantar heel pain: A system2727 atic review and meta-analysis. BMC Musculoskelet Disord 2005;6:19. 2728 43. Lou J, Wang S, Liu S, Xing G. Effectiveness of extracorporeal shock 2729 wave therapy without local anesthesia in patients with recalci2730 2731 trant plantar fasciitis: A meta-analysis of randomized controlled 2732 trials. Am J Phys Med Rehabil 2017;96:529-534. 2733 44. Costa ML, Shepstone L, Donell ST, Thomas TL. Shock wave therapy 2734 for chronic Achilles tendon pain: A randomized placebo-controlled 2735 2736 trial. Clin Orthop Relat Res 2005;440:199-204. 2737 45. Rasmussen S, Christensen M, Mathiesen I, Simonson O. Shockwave 2738 therapy for chronic Achilles tendinopathy: A double-blind, ran2739 domized clinical trial of efficacy. Acta Orthop 2008;79:249-256. 2740 2741 46. Rompe JD, Furia J, Maffulli N. Eccentric loading compared with 2742 shock wave treatment for chronic insertional achilles tendinopathy. 2743 A randomized, controlled trial. J Bone Joint Surg Am 2008;90:52-61. 2744 47. Jonsson P, Alfredson H, Sunding K, Fahlstrom M, Cook J. New 2745 2746 regimen for eccentric calf-muscle training in patients with chronic 2747 insertional Achilles tendinopathy: Results of a pilot study. Br J 2748 Sports Med 2008;42:746-749. 2749 48. Rompe JD, Furia J, Maffulli N. Eccentric loading versus eccentric 2750 2751 loading plus shock-wave treatment for midportion achilles ten2752 dinopathy: A randomized controlled trial. Am J Sports Med 2009; 2753 37:463-470. 2754 49. Mani-Babu S, Morrissey D, Waugh C, Screen H, Barton C. The effec2755 2756 tiveness of extracorporeal shock wave therapy in lower limb ten2757 dinopathy: A systematic review. Am J Sports Med 2015;43:752-761. 2758 50. Zwerver J, Hartgens F, Verhagen E, van der Worp H, van den Akker2759 Scheek I, Diercks RL. No effect of extracorporeal shockwave 2760 2761 therapy on patellar tendinopathy in jumping athletes during the 2762 competitive season: A randomized clinical trial. Am J Sports Med 2763 2011;39:1191-1199. 2764 51. Everhart JS, Cole D, Sojka JH, et al. Treatment options for patellar 2765 2766 tendinopathy: A systematic review. Arthroscopy 2017;33:861-872. 2767 52. Rompe JD, Cacchio A, Furia JP, Maffulli N. Low-energy extracor2768 poreal shock wave therapy as a treatment for medial tibial stress 2769 syndrome. Am J Sports Med 2010;38:125-132. 2770 2771 53. Saxena A, Fullem B, Gerdesmeyer L. Treatment of medial tibial 2772 stress syndrome with radial soundwave therapy in elite athletes: 2773 Current evidence, report on two cases, and proposed treatment 2774 regimen. J Foot Ankle Surg 2017;56:985-989. 2775 2776 54. Birnbaum K, Wirtz DC, Siebert CH, Heller KD. Use of extracorporeal 2777 shock-wave therapy (ESWT) in the treatment of non-unions. A review 2778 of the literature. Arch Orthop Trauma Surg 2002;122:324-330. 2779 55. Wang CJ, Chen HS, Chen CE, Yang KD. Treatment of nonunions of 2780 2781 long bone fractures with shock waves. Clin Orthop Relat Res 2001; 2782 387:95-101. 2783 56. Kuo SJ, Su IC, Wang CJ, Ko JY. Extracorporeal shockwave therapy 2784 (ESWT) in the treatment of atrophic non-unions of femoral shaft 2785 2786 fractures. Int J Surg 2015;24(pt B):131-134. 2787 57. Cacchio A, Giordano L, Colafarina O, et al. Extracorporeal shock2788 wave therapy compared with surgery for hypertrophic long-bone 2789 nonunions. J Bone Joint Surg Am 2009;91:2589-2597. 2790 2791 2792 2793 2794 Disclosure 2795 2796 2797 Q2 J.M.R. Spaulding Rehabilitation Hospital, Charlestown, MA 2798 Q3 Disclosure: nothing to disclose 2799 2800 E.B. Brigham and Women’s Hospital, Boston, MA 2801 2802 Disclosure: nothing to disclose 2803 2804 2805

58. Wang CJ, Wang FS, Huang CC, Yang KD, Weng LH, Huang HY. Treatment for osteonecrosis of the femoral head: Comparison of extracorporeal shock waves with core decompression and bonegrafting. J Bone Joint Surg Am 2005;87:2380-2387. 59. Wang CJ, Huang CC, Wang JW, Wong T, Yang YJ. Long-term results of extracorporeal shockwave therapy and core decompression in osteonecrosis of the femoral head with eight- to nine-year followup. Biomed J 2012;35:481-485. 60. Taki M, Iwata O, Shiono M, Kimura M, Takagishi K. Extracorporeal shock wave therapy for resistant stress fracture in athletes: A report of 5 cases. Am J Sports Med 2007;35:1188-1192. 61. Staples MP, Forbes A, Ptasznik R, Gordon J, Buchbinder R. A randomized controlled trial of extracorporeal shock wave therapy for lateral epicondylitis (tennis elbow). J Rheumatol 2008;35:2038-2046. 62. Chung B, Wiley JP. Effectiveness of extracorporeal shock wave therapy in the treatment of previously untreated lateral epicondylitis: A randomized controlled trial. Am J Sports Med 2004; 32:1660-1667. 63. Haake M, Konig IR, Decker T, et al. Extracorporeal shock wave therapy in the treatment of lateral epicondylitis: A randomized multicenter trial. J Bone Joint Surg Am 2002;84:1982-1991. 64. Pettrone FA, McCall BR. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. J Bone Joint Surg Am 2005;87:1297-1304. 65. Rompe JD, Decking J, Schoellner C, Theis C. Repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players. Am J Sports Med 2004;32:734-743. 66. Rompe JD, Maffulli N. Repetitive shock wave therapy for lateral elbow tendinopathy (tennis elbow): A systematic and qualitative analysis. Br Med Bull 2007;83:355-378. 67. Li W, Zhang SX, Yang Q, Li BL, Meng QG, Guo ZG. Effect of extracorporeal shock-wave therapy for treating patients with chronic rotator cuff tendonitis. Medicine (Baltimore) 2017;96:e7940. 68. Galasso O, Amelio E, Riccelli DA, Gasparini G. Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: A doubleblind, randomized, placebo-controlled trial. BMC Musculoskelet Disord 2012;13:86. 69. Ioppolo F, Tattoli M, Di Sante L, et al. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: A randomized clinical trial comparing two different energy levels. Phys Ther 2012;92:1376-1385. 70. Bannuru RR, Flavin NE, Vaysbrot E, Harvey W, McAlindon T. Highenergy extracorporeal shock-wave therapy for treating chronic calcific tendinitis of the shoulder: A systematic review. Ann Intern Med 2014;160:542-549. 71. Wu YC, Tsai WC, Tu YK, Yu TY. Comparative effectiveness of nonoperative treatments for chronic calcific tendinitis of the shoulder: A systematic review and network meta-analysis of randomized controlled trials. Arch Phys Med Rehabil 2017;98:1678-1692.e6. 72. Durst HB, Blatter G, Kuster MS. Osteonecrosis of the humeral head after extracorporeal shock-wave lithotripsy. J Bone Joint Surg Br 2002;84:744-746. 73. Erduran M, Akseki D, Ulusal AE. A complication due to shock wave therapy resembling calcaneal stress fracture. Foot Ankle Int 2013; 34:599-602.

A.S.T. Spaulding Rehabilitation Hospital, 300 First Street, Charlestown, MA 02129. Address correspondence to: A.S.T.; e-mail: [email protected] Disclosure: nothing to disclose Submitted for publication December 13, 2017; accepted May 6, 2018.

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