March 13th, 2004
AOSSM Specialty Day

Shockwave Therapy for Chronic Lateral Epicondylitis: An FDA Study

Authors:
  1. Richard L. Levitt MD, Doctors Hospital, Miami, FL
  2. F. Harlan Selesnick MD, Coral Gables, FL
  3. John Ogden MD, Orthopaedic Surgery & Sports Medicine, Atlanta, GA
Objective:  To determine the effectiveness of high energy extracorporeal shockwave (ESW) for the treatment of chronic lateral epicondylitis compared to a placebo group.
Methods:  This is an FDA approved, multicenter (7), prospective, randomized, double blinded, crossover, placebo controlled trial of ESW therapy for chronic lateral epicondylitis. 225 patients were enrolled and randomized to active (ESW) group (93); placebo group (90) and non randomized training patients(42). Inclusion criteria are 1) symptoms for at least 6 months, 2) failure of at least three attempts of conservative therapy, 3) pain score >5 on a 10cm VAS scale. A single dose of 1500 shocks at 16 Kv was administered under local anesthesia. Follow up evaluations were conducted at 8, 12, 26 and 52 weeeks and required a 50% improvement of pain scores at the 8 week period to be classified a success. Any patient who failed to meet success status at 8 weeks was allowed to undergo one repeat treatment.
Results:  91% of patients were available for follow up. At 8 weeks, 40% of ESW patients; 24% of placebo patients and 51% of non randomized patients were considered a success. 95% of the placebo patients who were a "failure" at 8 weeks elected to undergo ESW treatment and were followed accordingly. 50% of these achieved success status 8 weeks later. 78% of the active ESW group who were assigned a fail status at 8 weeks underwent a second procedure. 61% of these achieved a success status at the end of the second 8 week follow up. 74% of the non randomized patients who failed at 8 weeks elected a second treatment. 50% of these achieved success at 8 weeks. 100% of the patients who achieved success status at 8 weeks and were followed for one year maintained the success rating. There were no long term adverse reactions. Statistical analysis included t-tests for comparing means, Fisher's Exact test and Chi-square tests for two by two contingency tables.Results were significant for the composite results for all randomized patients (40% ESW versus 24% placebo).
Conclusions:  Final analysis of 225 patients confirm that a high energy ESW treatment is an effective modality for the treatment of chronic lateral epicondylitis compared to placebo controls. ESW therapy should be added to the armamentarium of non operative modalities for this disorder. Study limitations include a relatively small number of active treatment patients and should be expanded.
Keywords:
  1. Tendon
 Categories:
  1. CLINICAL: Elbow