Traditional Chinese medicine Washing Prescription for Lower Limb Sprain applied to chronic ankle sprain: a study protocol for a multicenter, double-blind, randomized controlled trial

Objective: The washing prescription for lower limb sprains (WPFLLS) has acceptable effects on chronic ankle sprains (CAS). To provide additional evidence supporting the efficacy of the WPFLLS prescription, we designed a multicenter, double-blind, randomized controlled trial with professional ballet dancers who have a high incidence of chronic ankle sprain as the study subjects. Materials and methods: This is a multicenter, double-blind, randomized controlled trial. According to the strict inclusion and exclusion criteria, 120 ballet dancers with CAS will be selected and randomly assigned to the traditional Chinese medicine (TCM) group or to the placebo group. Patients will be treated for 14 consecutive days and followed up for 28 days. The primary outcome is the ankle-hindfoot score of the American Orthopaedic Foot & Ankle Society (AOFAS). The secondary outcomes encompass the Visual Analog Scale (VAS), the Symptom Severity and Dance Performance Quality Index, and the frequency and dosage of externally applied rescue medication. Conclusions: This trial will provide high-quality clinical evidence on the efficacy and safety of WPFLLS in the treatment of CAS and provide clinical recommendations for subsequent studies on WPFLLS.