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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the use of extracorporeal shock waves to treat certain orthopedic conditions, such as calcific tendonitis of the shoulder (rotator cuff), delayed or nonunion fractures, plantar fasciitis, and lateral epicondylitis (tennis and golfers elbow) and other conditions.

Extracorporeal Shock Wave Therapy (ESWT) for Orthopedic Indications t - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Extracorporeal shock wave therapy (ESWT), low energy, high energy or radial wave, is unproven for the

treatment of:

• achilles tendonitis

• calcaneal spur

• calcific tendonitis of the shoulder (rotator cuff)

• chronic plantar fasciitis

• delayed or nonunion of fractures

• hammer toe

• lateral epicondylitis (tennis and golfers elbow)

• plantar fibromatosis

• plantar nerve lesion

• tenosynovitis of the foot or ankle

• tibialis tendinitis The available evidence does not allow a definitive determination of ESWT as an effective treatment of orthopedic conditions. Neither the short or long-term beneficial outcomes of ESWT have been demonstrated. Furthermore, the mechanism of action of ESWT in the treatment of localized painful musculoskeletal problems is not well understood and the techniques, optimal doses, and frequency of application have not been standardized.

For additional information, refer to the Lithotripsy for Salivary Stones medical policy.

Regulatory Requirements U.S. Food and Drug Administration (FDA): There have been no FDA approvals of ESWT devices for treatment of calcific tendonitis of the shoulder.

Currently, the FDA has approved five devices for the application of ESWT to either plantar fasciitis or lateral epicondylitis.

The OssaTron® lithotriptor (HealthTronics Inc.) was approved by the FDA for chronic proximal plantar fasciitis on October 12, 2000. The OssaTron was later approved (March 14, 2003) for chronic lateral epicondylitis. Additional information available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p990086a.pdf. Accessed on August 12, 2009.

The Dornier Epos Ultra® (Dornier MedTech) was approved by the FDA for chronic plantar fasciitis on January 15, 2002.

Additional information available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000048b.pdf. Accessed on August 12, 2009.

The Sonocur® Plus (Siemens Medical Solutions USA Inc.) was approved on July 19, 2002, for the treatment of chronic lateral epicondylitis. Additional information available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010039a.pdf.

Accessed on August 12, 2009.

The Orthospec Orthopedic ESWT (Medispec Ltd.) was approved for chronic plantar fasciitis on April 1, 2005. Additional information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040026b.pdf. Accessed August 12, 2009.

The Orbasone Pain Relief System (Orthometrix Inc.) was approved for chronic plantar fasciitis August 10, 2005.

Additional information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040039a.pdf. Accessed August Extracorporeal Shock Wave Therapy (ESWT) for Orthopedic Indications t - Commercial Medical Management Guideline 12, 2009.

A number of other ESWT devices are approved by the FDA for treatment of urolithiasis, but these devices cannot be marketed for orthopedic applications, and their use for orthopedic conditions is considered "off label."

Research Evidence Background Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to the painful region with the objective of reducing pain and promoting healing of the affected soft tissue. The shock waves for orthopedic indications are the same as those used to break up kidney stones, but have 10 times less energy.

Orthopedic indications for ESWT, called orthotripsy when used in an orthopedic setting, include localized, painful musculoskeletal conditions such as plantar fasciitis associated with calcaneus bone spurs. In this situation, ESWT serves as an alternative to surgery for patients with chronic heel pain that has not responded to conservative therapy. Other chronic orthopedic conditions for which ESWT has been proposed include epicondylitis humeri (tennis and golfer elbow), calcifying tendonitis in the shoulder (specifically rotator cuff), and promotion of bone healing in delayed and nonunion fractures. ESWT also has been used in experimentally to mobilize the cement used for total hip arthroplasty, since removal of the cement is a major impediment to replacement of a failed prosthesis.

Clinical Evidence Achilles Tendonitis: A detailed search of the medical peer-reviewed literature did not identify any clinical studies that evaluated extracorporeal shock wave therapy for the treatment of achilles tendonitis.

National Institute for Health and Clinical Evidence (NICE): A 2009 guidance statement found that the current evidence on the efficacy of ESWT is inconsistent and should only be used with special arrangements for clinical governance, consent and audit or research. NICE encourages further research into ESWT for Achilles tendinopathy in the form of clinical studies with clearly described patient selection and treatment protocols, including a description of local anesthesia use and the type of energy applied.

Calcaneal Spur: A randomized controlled study by Tornese et al. (2008) compared extracorporeal shock wave therapy in 45 subjects with a history of at least 6 months of heel pain. Patients were randomized into 2 groups (perpendicular and tangential technique) with 2 and 8 months follow-up. Each subject received a three-session ultrasound-guided extracorporeal shock wave therapy (performed weekly). Mayo Clinical Scoring System was used to evaluate each subject before and after treatment. Mayo Clinical Scoring System pretreatment scores were homogeneous between the groups (group A 55.2 +/-18.7; group B 53.5 +/- 20; P0.05). In both groups there was a significant (P0.05) increase in the Mayo Clinical Scoring System score at 2 months (group A 83.9 +/- 13.7; group B 80 +/- 15,8) and 8 months (group A 90 +/- 10.5; group B 90.2 +/-8.7) follow-up. The authors concluded that there was no difference between the two techniques;

however while the results appear promising additional studies with larger patient sample sizes are needed to further validate these results. In addition, there was a lack of evidence for the efficacy of ESWT when compared to sham therapy.

Calcific Tendonitis of the Shoulder (Rotator Cuff): In these studies, outcomes appeared to be related to level of energy applied to the injured region, with some pain relief provided by low-energy ESWT, and more sustained relief of pain and improvement of function after high-energy ESWT. Few of the studies provided data on the long-term effects of ESWT.

However, there is some evidence to suggest that relief may be sustained in patients who have radiographic evidence of disintegration of calcium deposits after lithotripsy treatment.

The 12 studies of calcific tendonitis (n=948) included 4 randomized controlled trials (RCTs), 3 of which were placebocontrolled. Selection criteria were fairly uniform across studies. Most studies included only patients with symptoms for at Extracorporeal Shock Wave Therapy (ESWT) for Orthopedic Indications t - Commercial Medical Management Guideline least 12 months and who had failed conservative treatment in the previous 6 months, with some studies specifying a minimum number of failed treatments. Approximately half the studies required that patients observe a period without treatment prior to initiation of the study intervention and did not allow additional treatments during the follow-up period other than exercises or physical therapy; most studies did not report any assessment of compliance. The other studies did not provide information about whether patients were told not to use secondary treatments.

Follow-up in these studies ranged from 3 months to 4 years. All patients made improvements following ESWT, but improvements were not always statistically significant or significantly greater than those in the control/comparison group.

Constant and Murley scale (CMS) scores (an outcome measure) at 6 months following last treatment ranged from 67.7 to 88.0, representing improvements of 25 to 35 points in four studies. Scores at 1 year were slightly better or slightly worse than 3- or 6-month scores (3 studies, n=274). Comparisons of different doses of ESWT suggested a dose-response relationship but do not identify a clear threshold.

Chronic Plantar Fasciitis: Most studies included only patients who had had symptoms for 6 months or longer, and some specified that certain types or a minimum number of conservative treatments must have been tried. There were some variations in technique. Double blinding was observed in most studies. A 3-month clinical endpoint was typical. Pain was the chief outcome assessed, most commonly by the Roles and Maudsley scoring system or a variation of it.

The studies below have been grouped as low energy (LE) ESWT if the energy was less than or equal to 0.12 mJ/mm2 or was adjusted to this level due to pain intolerance, and high energy (HE) if the energy was greater than 0.12 mJ/mm2, according to Speed (2004). Another type of ESWT is radial pressure wave therapy which uses a simple mechanical hammer to apply shock waves to superficial skin layers only.

Low-Energy (LE) ESWT: With respect to simple measures of pain, mean scores consistently showed short-term improvement following ESWT. Sham treatment produced short-term pain improvement but it was usually less, and the difference between sham and active ESWT was not always statistically significant. Between-group differences in the magnitude of pain improvement were found to be statistically significant by Cosentino et al. (2001) but were not significant in the studies by Buchbinder et al. (2002) and Speed et al. (2003). Buchbinder et al. also found improvement in both groups on several functional measures at 3 months, but between-group differences were insignificant.

Results reported by Haake et al. (2003) offer a better picture of the clinical significance of improvement. Less than half of patients in both groups had good or excellent Roles and Maudsley scores at 3 months. Approximately a third of patients in both groups had clinical success. The authors concluded that ESWT had offered no clinically meaningful benefit in this group of patients, but the 1-year results may have been confounded by the greater rate of subsequent secondary treatment in the placebo group.

Kudo et al. (2006) randomized 114 adults with chronic plantar fasciitis recalcitrant to conservative therapies for at least 6 months into two groups. One group received a single session of ESWT, the other group received placebo. The ESWT treated group demonstrated a statistically significant improvement in pain from baseline to 3 months according to Visual Analog Scale scores and in Roles and Maudsley Scores.

High-Energy (HE) ESWT: Short-term follow-up revealed mean reduction in pain for both the intervention and placebo/ comparison groups, with greater improvement in the patients who received active ESWT. Differences in both pain scores and in the proportion of patients who experienced clinical success were statistically significant. Long-term follow-up appears to suggest greater maintenance of success in patients who received ESWT than in patients allocated to placebo, but these results may be biased by the exclusion of losses to follow-up from analysis. Only one study by Ogden et al.

(2004a) used an intention-to-treat analysis. Losses to follow-up ranged from negligible to 4% for the 3 months evaluation, were approximately 14% for the 6-month evaluation, and ranged from 27% to 56% for the 1-year follow-up.

Extracorporeal Shock Wave Therapy (ESWT) for Orthopedic Indications t - Commercial Medical Management Guideline While studies of HE-ESWT appear to have more positive and more robust results, none of the reviewed studies directly tested the comparative efficacy of HE ESWT versus typical LE-ESWT, and a meta-analysis by Thomson et al. (2005) questions the clinical significance of the treatment effect. The meta-analysis evaluated the data from 897 patients and resulted in a pooled estimate of a mean 0.42-point reduction (confidence interval 0.02-0.82) on a 0 to 10 VAS in morning pain at 3 months. This mean difference was statistically significant. However, the authors question its clinical relevance because after the removal of the biggest source of bias (the two poorest quality studies), the results were not significant.

Furthermore, the authors tested for heterogeneity of effect in terms of VAS pain scores among six studies. They found no evidence of heterogeneity, which suggests that the effectiveness of ESWT does not depend on energy level.

The clinical significance of the treatment effect of HE-ESWT was also questioned in a review. Buchbinder concluded that 6 RCTs of ESWT did not provide substantive support for its use for plantar fasciitis because 3 RCTs, Buchbinder et al. (2002), Haake (2003), Speed et al. (2002) showed no benefit, two others Ogden (2001) and Buch et al. (2002) reported small benefits of questionable clinical importance, and only one with 45 participants reported a significant reduction in pain at six months after treatment Buchbinder (2004).

Malay et al. (2006) conducted a randomized, controlled, double-blinded, multicenter comparison of ESWT vs. placebo for plantar fasciitis. Patients were treated once by ESWT at energy levels (0.22 mJ/mm2 to 0.32 mJ/mm 2) (n = 115) or placebo control (n = 57). The VAS was used to measure results at three months follow-up. According to the blinded assessor, heel pain displayed a mean reduction of 2.51 in the ESWT group and 1.57 in the placebo group; this was statistically significant. According to the patients' self-assessment, heel pain displayed a mean reduction of 3.39 in the ESWT group and 1.78 in the placebo group, also statistically significant.

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