Background This clinical study was conducted to determine the safety and effectiveness of extracorporeal shock waves (ESW) to treat chronic lateral epicondylitis non-responsive to conservative treatment and persisting for at least 6 months. Methods Involved were seven test sites and 183 patients, divided between men and women with a mean age of 45.7 years. Test participants had a history of chronic lateral epicondylitis and were under the care of a physician. Participants were enrolled as nonrandomized and randomized to active treatment and placebo. Eight-week follow-up by blinded investigators determined baseline results of success criteria. Results Analysis showed that a single ESW treatment was effective in treating the condition when compared with placebo at 8 weeks. Long-term follow-up data showed maintenance of response in 8-week "success" patients. Of the active treatment participants who continued the study to long-term follow up, 40% met all success criteria compared with 24% of the placebo group (P=0.018). Conclusions It was concluded that the results of efficacy, which were adjusted for any differences between sites, were robust upon analysis. The data provide statistically significant outcomes indicating that ESW therapy is effective in the treatment of chronic lateral epicondylitis.
- Chronic lateral epicondylitis
- Extracorporeal shock waves (ESW)
- Shockwave treatment
- Spark gap technology
ASJC Scopus subject areas
- Orthopedics and Sports Medicine