MP 2.01.40

Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions

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Medical Policy
Section Medicine	Original Policy Date 5/31/01	Last Review Status/Date Reviewed with literature search/6:2007
Issue 3:2007		Return to Medical Policy Index

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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

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Description

Policy

Extracorporeal shock wave therapy (ESWT), using either a high- or low-dose protocol, is considered investigational, as a treatment of musculoskeletal conditions, including but not limited to plantar fasciitis; tendinopathies including tendinitis of the shoulder, tendinitis of the elbow (epicondylitis, tennis elbow), stress fractures, delayed union and non-union of fractures, and avascular necrosis of the femoral head.

Policy Guidelines

Benefit Application

Rationale

The most clinically relevant outcome measures of ESWT are pain and functional limitations. Pain is a subjective, patient-reported measure. Therefore, pain outcomes require quantifiable pre- and post-treatment measures. Pain is most commonly measured with a visual analog scale (VAS). Quantifiable pre- and post-treatment measures of functional status are also used, such as SF 12 and SF 36. Minor adverse effects of ESWT are common but transient, including local pain, discomfort, local trauma, bleeding, and swelling. More serious adverse outcomes of ESWT may potentially include neurologic damage causing numbness or tingling, permanent vascular damage, or rupture of a tendon or other soft tissue structure.

 

In 2001, TEC issued an Assessment that concluded ESWT met the TEC criteria as a treatment for plantar fasciitis in patients who had not responded to conservative therapies. (1) Therefore, the 2001 medical policy stated that ESWT would be considered medically necessary in these patients. A 2003 TEC Assessment reviewed subsequently available literature on ESWT for musculoskeletal conditions with a focus on 3 conditions: plantar fasciitis, tendinitis of the shoulder, and tendinitis of the elbow. (2) The 2003 TEC Assessment came to different conclusions, specifically, that ESWT did not meet the TEC criteria as a treatment of plantar fasciitis or other musculoskeletal conditions. Therefore, the policy statement was revised to indicate that ESWT is investigational. In October 2004, updated TEC Assessments were completed for plantar fasciitis and tendinitis of the elbow. (3, 4) The 2004 TEC Assessments concluded that ESWT did not meet TEC criteria for the treatment of plantar fasciitis or tendinitis of the elbow.

 

Plantar Fasciitis

The October 2004 TEC Assessment on extracorporeal shock wave treatment for plantar fasciitis (3) agreed with the 2003 Assessment and concluded that the evidence is not sufficient to permit conclusions on the health outcome effects of ESWT for chronic plantar fasciitis. Eight studies met the inclusion criteria for the 2004 Assessment. Five double-blind, randomized clinical trials reporting on 992 patients were considered to be of high quality and are summarized below.

Overall, evidence included in the 2004 TEC Assessment showed a statistically significant effect on between-group difference in morning pain measured on a 0–10 VAS score. Uncertain is the clinical significance of the change. The absolute value and effect size are small. The most complete information on the number needed to treat (NNT) to achieve 50%–60% reduction in morning pain is from 2 studies of high-energy ESWT (and including confidential data provided by Dornier), combined NNT = 7 (95% CI: 4–15). Improvements in pain measures are not clearly associated with improvements in function. Effect size for improvement in pain with activity was non-significant, based on reporting for 81% of patients in all studies and 73% of patients in high-energy ESWT studies. Success in improvement in Roles and Maudsley score was reported for fewer than half the patients: although statistically significant, confidence intervals were wide. Where reported, improvement in morning pain was not accompanied by significant difference in quality-of-life measurement (SF-12, physical and mental scales) or use in pain medication.

Subsequently, Ogden et al (12) reported additional follow-up from the 12-week result (5) included in the 2004 TEC Assessment (3). However, after 12 weeks, randomization was not preserved, making conclusions from the follow-up problematic.

In addition, results have been reported to the FDA from trials delivering ESWT with the Orthospec™, Orthopedic ESWT, and Orbasone™ Pain Relief System.

• Orthospec™ (13) Efficacy was examined in a multicenter, double-blind, sham-controlled trial randomizing 172 participants with chronic proximal plantar fasciitis failing conservative therapy to ESWT or sham treatments in a 2 to 1 ratio. At 3 months, the ESWT arm had less investigator-assessed pain with application of a pressure sensor (0.94 points lower on a 10-point VAS, 95% CI: 0.02 to 1.87). However, there was no difference in improvement in patient-assessed activity and function between ESWT and sham groups.
• Orbasone™ (14) In a multicenter, randomized, sham-controlled, double-blind trial, 179 participants with chronic proximal plantar fasciitis were randomized to active or sham treatment. At 3 months, both active and sham groups improved in patient-assessed pain on awakening (by 4.6 and 2.3 points respectively on a 10-point VAS; crude difference between groups at 3 months of 2.3, 95% CI: 1.5 to 3.3). While ESWT was associated with more rapid improvement (and statistically significant) in a mixed-effects regression model, insufficient details were provided to evaluate the analyses.

While approved by the FDA for treatment of chronic plantar fasciitis and examined for efficacy in apparently well-designed, randomized, double-blind, controlled trials, the weight of evidence remains consistent with the conclusions of the 2004 TEC Assessment (3). Definitive, clinically meaningful treatment benefits at 3 months were not apparent nor was it evident that the longer-term disease natural history was altered. Finally, a recent meta-analysis conducted by Thomson et al (15) included results from 6 randomized, controlled trials (897 participants). For the endpoint of morning pain assessed using a VAS, they concluded that although statistically significant, the effect size was very small. Furthermore, excluding the two poorest quality trials from the meta-analysis resulted in a statistically insignificant effect.

Tendinitis of the Elbow

Six randomized, double-blinded, placebo-controlled trials enrolling 808 patients with lateral epicondylitis met the inclusion criteria for the 2004 TEC Assessment (4). Four trials were rated “good” quality and are summarized below.

• SONOCUR trial. (16) In this trial, 114 patients were randomized to low-energy ESWT or sham ESWT for 3 treatment sessions administered in 1-week intervals. The main outcome measures were percent response on self-reported pain scale (at least 50% improvement on 0–100 VAS) and change in the Upper Extremity Function Scale (UEFS). Results of the 2 main outcome measures at 3 months showed greater improvement in the ESWT group. Response rate was 60% in the active treatment group and 29% in the placebo group ('p=0.001). There was a 51% improvement in the UEFS score for the active treatment group, compared with a 30% improvement in the placebo group (p less than 0.05).
• OssaTron. (17) This trial randomized 183 patients to a single session of high-energy or sham ESWT. Treatment success was a 50% improvement on investigator and self-assessment of pain on a 0–10 VAS and no or rare use of pain medication. At the 8-week follow-up, the ESWT group had a greater rate of treatment success than the placebo group (35% vs. 22%,p less than 0.05). Mainly responsible for group differences in treatment success was the investigator assessment of pain (48% vs. 29%, p less than 0.01); the improvements in self-assessment of pain (81% vs. 70%, p = 0.06) and non-use of pain medication (81% vs. 70%, p = 0.09) were only marginal. 
• Haake et al (18) This trial randomized 272 patients to 3 sessions of low-energy or sham ESWT. Treatment success was defined as achieving a Roles and Maudsley score of 1 or 2 with no additional treatments. At 12 weeks, the ESWT success rate was 25.8%, and the placebo success rate was 25.4%. The percentage of Roles and Maudsley scores below 3 did not differ between groups at either 12 weeks (31.7% ESWT vs. 33.1% placebo) or at 1 year (65.7% ESWT vs. 65.3% placebo) of follow-up. Furthermore, the groups did not differ along any of 5 pain assessment measures or on grip strength.
• Rompe et al (19) This trial randomized 78 tennis players to 3 treatments at week intervals of low-energy or sham ESWT. Outcomes included pain ratings during wrist extension and the Thomsen Provocation Test, the Roles and Maudsley score, the Upper Extremity Function score, grip strength, and satisfaction with return to activities. At 3 months’ follow-up, the ESWT group, compared to placebo, significantly improved on all outcomes except grip strength. Treatment success (at least a 50% decrease in pain) was 65% for the ESWT group and 28% for the placebo group (p less than 0.01) and 65% of the ESWT group compared to 35% of the placebo group were satisfied with their return to activities (p = 0.01).

Since the 2004 TEC Assessment (4), Pettrone and McCall (20) reported results from a randomized double-blind trial conducted in 3 large orthopedic practices for 114 patients receiving either ESWT in a "focused" manner (2,000 impulses at 0.06 mJ/mm-2 without local anesthesia) weekly for 3 weeks or placebo. Randomization was maintained through 12 weeks, and benefit demonstrated with respect to a number of outcomes: pain, functional scale, and activity score. Pain assessed on the VAS (scaled here to 10 points) declined at 12 weeks in the treated group from 7.4 to 3.8 (mean 3.6, 95% CI: 2.8 to 4.5); among placebo patients from 7.6 to 5.1 (mean 2.4, 95% CI: 1.6 to 3.3). A reduction in Thomsen test pain of at least 50% was demonstrated in 60.7% of those treated compared to 29.3% in the placebo group (ARR 31.4%, 95% CI: 13.2 to 46.9). Mean improvement on a 10-point upper extremity functional activity score was 2.4 for ESWT-treated patients compared to 1.4 in the placebo group—difference at 12 weeks of 0.9 (95% CI .18 to 1.6).

This study found benefit of ESWT for lateral epicondylitis over 12 weeks. However, the placebo group also improved significantly; whether the natural history of disease was altered is unclear. In the context of mixed results from previous studies, only exceedingly convincing differential outcomes would provide sufficient evidence to alter the conclusions of the 2004 TEC Assessment. Further, a recent Cochrane review (21), which included the Pettrone and McCall trial, concluded “there is ‘Platinum’ level evidence [the strongest level of evidence] that shock wave therapy provides little or no benefit in terms of pain and function in lateral elbow pain.”

Current evidence does not support the use of ESWT to treat lateral epicondylitis.

Other Indications

Costa et al conducted a randomized, double-blind, placebo-controlled trial of ESWT for chronic Achilles tendon pain treated monthly for 3 months. (22) The study randomized 49 participants and was powered to detect a 50% reduction in VAS pain scores. No difference in pain relief at rest or during sport participation was found at 1 year. Two older ESWT-treated participants experienced tendon ruptures.

Other possible uses of ESWT noted in the literature but not supported by evidence include: stress fracture, delayed union and non-union of bone fractures, avascular necrosis of the femoral head, osteochondritis dissecans, patellar tendinitis, and other forms of chronic tendinitis. Specifically, a literature search identified no controlled clinical trials for any of these indications.

2006 – 2007 Update

A literature search was conducted using MEDLINE through April 2007. Given the findings from existing studies noted above, high-quality randomized trails with large numbers of patients would have to demonstrate a clear and substantial benefit for ESWT in these musculoskeletal conditions to warrant a change in the policy statement. None of the studies identified had such results. For example, Dorotka reported on the results of 41 patients with chronic plantar fasciitis who were randomized to have the heel spur located by fluoroscopy versus the point of maximal tenderness. (23) Thus the policy statement is unchanged.

A summary by the Canadian Agency for Drugs and Technologies in Health (CADTH) noted that results from randomized trails of ESWT for plantar fasciitis have been conflicting. (24) The report notes that the “lack of convergent findings from randomized trails of ESWT for chronic plantar fasciitis suggests uncertainty about its effectiveness. The evidence reviewed in this bulletin does not support the use of this technology for this condition.” Similarly a report by CADTH on ESWT for chronic lateral epicondylitis notes that the results from randomized trials have been conflicting and half of the studies showed no benefit over placebo for any outcome measures. (25) The report notes that “the lack of convincing evidence regarding its effectiveness does not support the use of ESWT for CLE (chronic lateral epicondylitis).”

References:

1. 2001 TEC Assessment: Extracorporeal shock wave treatment for musculoskeletal indications
2. 2003 TEC Assessment: Extracorporeal shock wave treatment for musculoskeletal indications.
3. 2004 TEC Assessment: Extracorporeal shock wave treatment for chronic plantar fasciitis.
4. 2004 TEC Assessment: Extracorporeal shock wave treatment forchronic tendinitis of the elbow.
5. Ogden JA, Alvarez R, Levitt R et al. Shock wave therapy for chronic proximal plantar fasciitis. Clin Orthop 2001; 387:47-59.
6. HealthTronics Surgical Services Inc. Supplementary data including " Final report G960232 for HealthTronics OssaTron™ indicated for ESWL treatment of Chronic Proximal Plantar Fasciitis," submitted to U.S. Food and Drug Administration (FDA) on April 6, 2001.
7. Buchbinder R, Ptasznik R, Gordon J et al. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial. JAMA 2002; 288(11):1364-72.
8. Haake M, Buch M, Schoellner C et al. Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. BMJ 2003; 327(7406):75-80.
9. Rompe JD, Decking J, Schoellner C et al. Shock wave application for chronic plantar fasciitis in running athletes. A prospective, randomized, placebo-controlled trial. Am J Sports Med 2003; 31(2):268-75.
10. Dornier Medical Systems Inc. Dornier Epos™ Ultra summary of safety and effectiveness, PMA #P000048.
11. Theodore GH, Buch M, Amendola A et al. Extracorporeal shock wave therapy for the treatment of plantar fasciitis. Foot Ankle Int 2004; 25(5):290-7.
12. OgdenJA. Alvarez RG, Levitt RL. Et al. Electrohydraulic high-energy shock-wave treatment for chronic plantar fasciitis. J Bone Joint Surg Am 2004; 86-A(10):2216-28.
13. U.S.Food and Drug Administration (FDA) Center for Devices and Radiological Health. Orthospec™ summary of safety and effectiveness available at http://www.fda.gov/cdrh/pdf4/p040026b.pdf. Last accessed November 30, 2005.
14. US. Food and Drug Administration (FDA) Center for Devices and Radiological Health. Orbasone™ summary of safety and effectiveness available at http://www.fda.gov/cdrh/PDF4/p040039b.pdf. Last accessed November 30, 2005.
15. Thomson CE, Crawford F, Murray GD. The effectiveness of extra corporeal shock wave therapy for plantar heelpain:asystematicreviewandmeta-analysis.BMCMusculoskeletDisord2005;6(1):19.Availableonlineathttp://www.pubmedcentral.gov/articlerender.fcgi?tool=pubmed&pubmedid=15847689. Last accessed December 2, 2005.
16. U.S.Food and Drug Administration (FDA) Center for Devices and Radiological Health. SONOCUR® summary of safety and effectiveness available at http://www.fda.gov/cdrh/pdf/P010039b.pdf. Last accessed January 10, 2003.
17. U.S.Food and Drug Administration (FDA) Center for Devices and Radiological Health. OssaTron® summary of safety and effectiveness available at http://www.fda.gov/cdrh/pdf/p990086b.pdf. Last accessed January 14, 2003.
18. Haake M, Konig IR, Decker T et al. Extracorporeal shock wave therapy for lateral epicondylitis: a randomized multicenter trial. J Bone Joint Surg Am 2002; 84-A(11):1982-91.
19. Rompe JD, Decking J, Schoellner C et al. Repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players. Am J Sports Med 2004; 32(3):734-43.
20. Pettrone FA, McCall BR. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. J Bone Joint Surg Am 2005; 87(6):1297-304.
21. Buchbinder R, Green S, Youd J et al. Shock wave therapy for lateral elbow pain. Cochrane Database Syst Rev 2005; 4:CD003524.
22. Costa ML, Shepstone L, Donell ST et al. Shock wave therapy for chronic Achilles tendon pain: a randomized placebo-controlled trial. Clin Orthop Relat Res 2005; 440:199-204.
23. Dorotka R, Sabeti M, Jimenez-Boj E et al. Location modalities for focused extracorporeal shock wave application in the treatment of chronic plantar fasciitis. Foot Ankle Int 2006; 27(11):943-7.
24. Ho C. Extracorporeal shock wave treatment for chronic plantar fasciitis (heel pain). Issues Emerg Health Technol 2007; 96(part 1):1-4.
25. Ho C. Extracorporeal shock wave treatment for chronic lateral epicondylitis (tennis elbow). Issues Emerg Health Technol 2007; 96(part 2):1-4.

Index

Policy History

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