Long-term results of radial extracorporeal shock wave treatment for chronic plantar fasciopathy: A prospective, randomized, placebo-controlled trial with two years follow-up

Abstract

Numerous randomized controlled trials (RCTs) demonstrated efficacy and safety of extracorporeal shock wave therapy (ESWT) for chronic plantar fasciopathy (cPF). However, only two such RCTs investigated a follow-up period of more than 1 year, both applying focused ESWT. Corresponding data for radial ESWT (rESWT) have not yet been reported. We therefore tested the hypothesis that rESWT is effective and safe for the management of cPF with long-term follow-up of 2 years. To this end n = 50 patients with cPF were randomly allocated to either two sessions of rESWT (one session per week; 2,000 shock waves with energy flux density of 0.16 mJ/mm2 per session) (n = 25) or to placebo treatment (n = 25). Evaluation was by change in Visual Analog Scale (VAS) score and Roles and Maudsley (RM) score. Mean pretreatment VAS scores for the rESWT and placebo groups were 8.5 and 8.9, respectively. 1, 3, 6, 12, and 24 months after treatment, the mean VAS scores for the rESWT and placebo groups were 0.6, 1.1, 0.5, 2.3, and 1.4 and 7.6, 7.7, 7.4, 6.9, and 5.6 (p < 0.001), respectively. Differences in mean RM scores were statistically significant between groups at 1, 3, 6, 12, and 24 months post treatment, but not at baseline. There were no significant complications. These data indicate that rESWT is effective and safe for the management of cPF with long-term follow-up of 2 years. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:1532–1538, 2017.