Background: Plantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally considered self-limiting with persistent symptoms that often last for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. Heavy-slow resistance training and radiofrequency microtenotomy for the treatment of plantar fasciopathy have shown potentially positive effects on short- and long-term outcomes (> 3 months). However, the effect of heavy-slow resistance training compared with a radiofrequency microtenotomy treatment is currently unknown. This trial compares the efficacy of heavy-slow resistance training and radiofrequency microtenotomy treatment with supplemental standardized patient education and heel inserts in improving the Foot Health Status Questionnaire pain score after 6 months in patients with plantar fasciopathy. Methods: In this randomized superiority trial, we will recruit 70 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of two groups: (1) heavy-slow resistance training, patient education and a heel insert (n = 35), and (2) radiofrequency microtenotomy treatment, patient education and a heel insert (n = 35). All participants will be followed for 1 year, with the 6-month follow-up considered the primary endpoint. The primary outcome is the Foot Health Status Questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a Global Perceived Effect scale, the physical activity level, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment. Discussion: By comparing the two treatment options, we should be able to answer if radiofrequency microtenotomy compared with heavy-slow resistance training is superior in patients with plantar fasciopathy. Trial registration: ClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.
Bibliografisk noteFunding Information:
The trial is funded by chief physician Jørgen Werner Schous and his wife, Else-Marie Schou, born Wonge’s Foundation, Grethe & Sigurd Soerensen Foundation, Merchant L.F. Foghts Foundation, and the Research Council of Lillebaelt Hospital - University Hospital of Southern Denmark. A copy of the original funding documents has been added as an additional file on submission. The funders will have no role in the design, conduct, collection of the data, analysis, writing, or reporting of the trial.