LCD L38775: Extracorporeal Shock Wave Therapy (ESWT)

Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment that involves delivery of an acoustic shock wave to a specific area of the body. The objective of this treatment is to reduce pain and stimulate healing of the affected area. The acoustic waves travel through fluid and soft tissue, and their effects occur at sites where there is a change in impedance, such as the bone/soft-tissue interface.

ESWT has become a proposed treatment option for specific musculoskeletal conditions. These conditions include, but are not limited to, calcific tendinopathy of the shoulder, elbow tendinopathy (lateral/medial epicondylitis), carpal tunnel syndrome (CTS), greater trochanteric pain syndrome (GTPS), fractures and delayed unions/nonunions, osteonecrosis of the femoral head (ONFH), and patellar tendinopathy (PT).

The mechanism by which ESWT achieves a therapeutic intervention in musculoskeletal conditions is not completely known. Numerous hypotheses have been proposed:

• ESWT may disrupt fibrous tissue allowing for the subsequent promotion of revascularization and healing of tissue.

• Direct and indirect effects of the shock waves may damage cell membranes; reducing the ability of nociceptors to transmit pain signals 11 and/or promote healing.

• Shock waves break up calcium deposits, loosen structures, and promote resorption of calcium; thereby decreasing pain and improving function.

This A/B MAC considers ESWT (high energy) not reasonable and necessary for the treatment of musculoskeletal conditions and therefore not covered.

Calcific tendinopathy of the shoulder:

Daecke, et al. (2002) conducted a study to evaluate the long-term effects and any complications of ESWT for calcific tendinitis (CT) of the shoulder. 9 The 4-year outcome was determined in a prospective study of 115 patients who presented with painful CT for >12 months and conservative treatment (physiotherapy and subacromial steroid injections) for at least 6 months without effect. For this study, the CT patients had persistent shoulder pain associated with calcareous deposits in the supraspinatus or infraspinatus tendon. Patients were treated with high-energy ESWT by 2 different protocols. One day prior to ESWT, each patient underwent an anteroposterior x-ray in internal and external rotation of the shoulder and a functional examination of the shoulder was performed and documented with use of the Constant-Murley (CM) score. One session (group A, n = 56) or 2 sessions (group B, n = 59) of high-energy shockwave therapy were administered to each patient. The shockwave intensity was increased, within the first 300 impulses, from low energy up to an energy flux density (EFD) of 0.3 mJ/mm 2 . Outcome was determined by functional examination, x-rays of the shoulder, and the patients’ own assessments at 3 months, 6 months, and 4 years post-therapy. Results at 6-months showed that the level of success achieved in pain relief and CM score was energy-dependent and that there were significant differences in radiologic changes between the groups. Four years following ESWT, 20% of the entire patient population had undergone surgery on the involved shoulder. The effects of ESWT not followed by any other therapy within the first 6 months were evaluated in 59% (n = 68) of the original 115 patients. Frequency of subjective success (increase in pain relief) was seen in 78% of patients in group A and 87% in group B. The CM score increased from a mean of 45 pre-treatment to 88 in group A and 85 in group B post-treatment. Radiologic changes were found in 93% of patients in each group. The authors concluded that the failure rate after ESWT was high, but the treatment was successful for 70% of the patients in this study and no long-term complications were seen.

Ioppolo, et al. (2012) noted that limited evidence was available for the useful range of ESWT doses in the treatment of supraspinatus calcifying tendinitis (SCT). The authors published a single-blind randomized clinical trial to compare 2 different ranges of EFD in treatment of SCT with ESWT. 12 Forty-six patients with SCT were randomized to 2 groups that received different therapeutic energy doses of ESWT: (1) group A (n=23) received ESWT at an energy level of 0.20 mJ/mm², and (2) group B (n=23) received ESWT at an energy level of 0.10 mJ/mm². Both groups received 2,400 pulses once a week for 4 weeks. The change in mean CM score from baseline to 3 and 6 months was the primary endpoint. The change in the mean visual analog scale (VAS) scores from baseline to 3- and 6-months post-treatment and radiographic change in size of calcium deposits were evaluated as secondary endpoints. At 12 months, pain relief was assessed using a numeric rating scale. Results showed that significant clinical improvement based on mean CM scores was observed after 6 months in group A ( sample mean =79.43, SD=10.33) compared with group B ( sample mean =57.91, SD=6.53). Also, after 6 months, a significant decrease in VAS scores was found in group A ( sample mean =2.09, SD=1.54) compared with group B ( sample mean =5.36, SD=0.78). The disappearance of calcific deposits was similar in both groups. The authors concluded that for treatment of SCT, an energy level of 0.20 mJ/mm² for ESWT appears to be more efficacious than an energy level of 0.10 mJ/mm² regarding pain relief and functional improvement. However, the results are limited secondary to small sample size and lack of a control group.

A prospective randomized trial of calcifying tendinitis of the rotator cuff by Albert, et al. (2007) compared the efficacy of dual treatment sessions delivering 2500 extracorporeal shock waves at either high- or low-energy. 1 Patients were eligible for the study if they had > 3 months history of calcifying tendinitis of the rotator cuff, with calcification measuring 10 mm or more in maximum dimension. The change in the CM score was the primary outcome measure. Eighty patients were enrolled in the study (40 in each group). Patients were re-evaluated at a mean of 110 (41 to 255) days post-treatment when the increase in CM score was significantly greater (t-test, p = 0.026) in the high-energy treatment group than in the low-energy group. In the high-energy group, the improvement from baseline was significant with a mean gain of 12.5 (-20.7 to 47.5) points (p