Extracorporeal Shock Wave Therapy for Chronic Painful Heel Syndrome: A Prospective, Double Blind, Randomized Trial Assessing the Efficacy of a New Electromagnetic Shock Wave Device

• Published in: The Journal of foot and ankle surgery Vol. 46; no. 5; pp. 348 - 357
• Main Authors: Gollwitzer, Hans, MD, CCRP, Diehl, Peter, MD, von Korff, Alexej, MD, Rahlfs, Volker W., Dr, CStat, RSS, Gerdesmeyer, Ludger, MD, PhD
• Format: Journal Article
• Language: English
• Published: Baltimore, MD Elsevier Inc 01.09.2007; Data Trace
• Subjects: Adult; Aged; Biological and medical sciences; calcaneal spur; Chronic Disease; Double-Blind Method; ESWT; extracorporeal shockwave therapy; Fasciitis, Plantar - physiopathology; Fasciitis, Plantar - therapy; Female; Heel; heel pain; High-Energy Shock Waves - therapeutic use; Humans; lithotripsy; Male; Medical sciences; Middle Aged; Orthopedic surgery; Orthopedics; Pain Management; plantar fasciitis; Prospective Studies; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Syndrome; Treatment Outcome; heel pain; ESWT; calcaneal spur; lithotripsy; plantar fasciitis; extracorporeal shockwave therapy; Shock; Connective tissue disease; Skin disease; Toxicity; Heel; Lower limb; Instrumentation therapy; Electromagnetic device; Fasciitis; Shock wave; Foot; Foot sole; Chronic; Pain; Lithotripsy
• ISSN: 1067-2516; 1542-2224
• DOI: 10.1053/j.jfas.2007.05.011

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/mm2 ) 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.