Published data describing the efficacy of
extracorporeal shock wave therapy for the treatment of plantar heel
pain provide conflicting results, and optimal treatment guidelines are yet to be determined. To assess the efficacy and safety of
extracorporeal shockwave therapy compared with placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device, we undertook a prospective, double-blind, randomized, placebo-controlled trial conducted among 40 participants who were randomly allocated to either active, focused
extracorporeal shockwave therapy (0.25 mJ/mm(2)) or
sham shockwave
therapy. Both groups received 3 applications of 2000 shockwave impulses, each session 1 week apart. The primary outcome was the change in composite heel
pain (morning
pain,
pain with
activities of daily living, and
pain upon application of pressure with a focal force meter) as quantified using a visual analog
pain scale at 12 weeks after completion of the interventions compared with baseline. Secondary endpoints included changes in morning
pain,
pain with
activities of daily living, and
pain upon application of pressure with a focal force meter, as measured on a visual analog
pain scale, as well as the change in the Roles and Maudsley score, at 12 weeks after the baseline measurement. Active
extracorporeal shockwave therapy resulted in a 73.2% reduction in composite heel
pain, and this was a 32.7% greater reduction than that achieved with placebo. The difference was not statistically significant (1-tailed Wilcoxon Mann-Whitney U test, P =.0302), but reached clinical relevance (Mann-Whitney effect size = 0.6737). In regard to the secondary outcomes, active
extracorporeal shockwave therapy displayed relative superiority in comparison with the
sham intervention. No relevant adverse events occurred in either intervention group. The results of the present study support the use of electromagnetically generated
extracorporeal shockwave therapy for the treatment of refractory plantar heel
pain.