Radial extracorporeal shock wave device appearance does not influence clinical outcomes: A randomized controlled trial

Abstract

Objective: To determine whether the appearance of a radial extracorporeal shock wave device affects clinical outcomes in chronic plantar fasciitis. Study design: Randomized controlled parallel assessor-blinded clinical trial. Material and methods: A total of 135 patients were assigned to 3 groups: group I, standard radial extracorporeal shock wave device; group II, standard radial extracorporeal shock wave device modified to give a more sophisticated appearance; group III, standard radial extracorporeal shock wave device modified to give a more austere appearance. The radial extracorporeal shock waves emitted by the 3 devices were identical. Primary outcome was foot function, measured with the Foot Function Index. Secondary outcomes were pain at different times, measured with a visual analogue scale, and plantar fascia thickness, measured with ultrasound. Results: All variables decreased significantly from baseline assessment, in all 3 groups and at all time-points: 1, 2, 4 and 14 months after the last session (p < 0.001). There were no significant differences between groups for any of the variables assessed. Conclusion: Device appearance had no statistically significant influence on clinical outcomes in patients with chronic plantar fasciitis treated with radial extracorporeal shock wave therapy.

Keywords

• placebo effect
• nocebo effect
• plantar fasciitis
• shock wave, therapeutic context.