Design of multicenter trial with the aim to test the efficiency of extracorporeal shock-wave therapy (ESWT) as a treatment for lateral epicondylitis of the elbow.

Introduction: Previously published studies concerning, extracorporeal shock-wave therapy (ESWT) in the treatment of lateral epicondylitis do not fulfil the biometric standards of modern clinical research. The objectiv of the trial is to show that ESWT is effective in the treatment of chronic LE. Method: A prospective, randomised, placebo-controlled, single-blinded, multicenter trial with an independent blinded observer was designed. The effectiveness of ESWT is evaluated by comparison with a control group in which sham-ESWT is performed, both under local anaesthesia. Outcome is determined on the basis of the Roles/Maudsley-Score. Inclusion criteria are a history of at least 6 months of LE and failure of conventional treatment. The therapy includes 3 sessions of low energy ESWT with 2000 impulses (energy flux density 0.07-0.09 mJ/mm(2)). Sample size is 272 patients. Status: Randomisation started in October 1998 and is planned over a period of two and a half years. Conclusion: Only a randomised clinical trial with adequate contol of placebo effects and observer bias can provide the required evidence for the efficiency of ESWT in the treatment of lateral epicondylitis of the elbow.