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.