This clinical study was conducted to determine the safety and effectiveness of Extracorporeal Shock Waves (ESW) using the HealthTronics OssaTron system to treat Chronic Lateral Epicondylitis - a condition defined as lateral epicondylitis (tennis elbow) that is non-responsive to other conservative treatment and persists for 6 months or more.
Materials and Methods
- This randomized, placebo-controlled clinical trial involved 7 test sites* and 225 patients evenly divided between male and female, with a mean age of 45.7.
- Test sites included: HealthSouth Doctors' Hospital, Coral Gables, FL (E1), Atlanta Medical Center, Atlanta, GA (E2), Memorial Hospital, Chattanooga, TN (E3), American Sports Institute, Birmingham, AL (E4), Baylor College of Medicine, Houston, TX (E5), University of Rochester School of Medicine and Dentistry, Rochester, NY (E6), and Southwest Ambulatory Surgicenter, Oklahoma, City, OK (E7).
- Test patients had a history of Chronic Lateral Epicondylitis, were under the care of a physician, and were non-responsive to both physical therapy and minimally two pharmacological treatments.
- Patients received 90 placebo and 273 active Extracorporeal Shock Wave (ESW) treatments with the OssaTron ESW system, which utilizes electrohydraulic "spark gap" technology to generate shock waves.
- An 8-week follow-up was established to determine from both investigator and subject self-assessments baseline results of success criteria (minimum 50% improvement and VAS score of 4.0 or less) and medication use.
- A short-term follow-up of 8 weeks identified a "success" or "failed" status for all patients - qualifying some for long-term follow-up.
- Investigator assessments showed that subjects randomized to active ESW treatment improved from a mean baseline VAS score of 7.73 to 3.64 at 8 weeks, with a median VAS score of 3.35. Forty-three of the 82 subjects (52.4%) met the success criteria for this parameter.
- Subjects randomized to placebo treatment improved from a mean baseline VAS score of 7.81 to 5.17 at 8 weeks, with a median VAS score of 5.5. Twenty-six of the 83 subjects met the success criteria for this parameter.
- No unanticipated or serious adverse event has occurred to date in any test patient.
Analysis showed that a single OssaTron ESW treatment is effective in treating Chronic Lateral Epicondylitis, when compared to placebo treatment at 8 weeks. Of the 82 active treatment subjects, 33 (40%) met all success criteria, compared to 20 of the 83 placebotreated (24%) - a difference that is significant at a p level of 0.018.
*Study investigators were Evan D. Collins, MD, David H. Hildreth, MD, et al. A full listing of participating investigators can be found in the final report for the HealthTronics OssaTron® indicated for ESW Treatment of Chronic Lateral Epicondylitis.