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.
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.
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).
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.
aDepartment of Orthopaedic Surgery, The Methodist Hospital System, Houston TX
bDepartment of Orthopedics, Richmond Bone & Joint Clinic, Richmond, TX
cMethodist Center for Orthopaedic Surgery at Willowbrook, Methodist Willowbrook Hospital, Houston, TX
Financial disclosure: Grants and outside funding for this study were provided by: HealthTronics of Atlanta, Georgia and Baylor College of Medicine of Houston, TX.
Correspondence to Evan D. Collins, MD, Department of Orthopaedic Surgery, The Methodist Hospital System, 6550 Fannin, Suite 2525, Houston, TX 77030 Tel: +713 441 3535; fax: +713 790 2142; e-mail: Ecollins@tmhs.org