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RADIAL SHOCK WAVE THERAPY (RESWT) IN CHRONIC PLANTAR HEEL PAIN: A PROSPECTIVE RANDOMIZED PLACEBO CONTROLLED TRIAL.

Purpose: To determine the effectiveness of rESWT for chronic plantar heel pain.

Materials and methods: 70 patients were enrolled and randomly assigned to either active or placebo treatment. 2000 shock waves per session and 3 sessions were applied, interval of 2 weeks. The primary efficacy criteria were subjective outcome on Visual Analogue Scale (VAS) and Roles- and Maudsley-Score. The primary study endpoint was 12 weeks. Nonparametric procedures have been used for teststatistical analyses. In addition to P-values, results have been presented by means of Mann-Whitney estimators as nonparametric effect sizes and their one-sided 97.5% confidence intervals as required by the ICH E9 Guideline ( Exact Wilcoxon-Mann-Whitney test, ï ¡ = 0.025 one-sided)

Results: 62 patients could be examined 12 weeks after rESWT. Drop out rate 12%. Significant decrease in pain sensation could be found in the active group (p<0, 001). The VAS decreased from 7.1 (+/– 1,6) to 3.6 (+/– 2,3). Placebo group showed slight improvement from 6.7 (+/–1,8) to 5.9 (+/– 2,2). The effect size (Mann-Whitney) denotes a large superiority of the rESWT group (MW = 0.72). The lower bound of the asymptotic one-sided 97.5% confidence interval denotes superiority of the test group (LB-CI = 0.58). The results scored on Roles- and Maudsley-Score showed similar improvement. Only minor side effects as petechial bleeding and swelling were detected.

Conclusion: The radial shock wave therapy is effective and save in treatment of chronic heel pain.

Theses abstracts were prepared by Professor Roger Lemaire. Correspondence should be addressed to EFORT Central Office, Freihofstrasse 22, CH-8700 Küsnacht, Switzerland.