Electroacupuncture Combined with Diclofenac Emulgel for Post-Traumatic Ankle Osteoarthritis: A Randomized Controlled Trial Protocol

Purpose: Post-traumatic ankle osteoarthritis (PTAOA) is a common chronic condition associated with persistent pain, functional limitation, and reduced quality of life. Electroacupuncture (EA) has shown potential as a non-pharmacological intervention for osteoarthritis, but high-quality evidence in PTAOA remains limited. This study aims to evaluate the efficacy and safety of EA combined with topical diclofenac emulgel in patients with PTAOA and to explore potential inflammatory mechanisms. Patients and Methods: This is a single-center, randomized, sham-controlled superiority trial. A total of 78 patients with PTAOA will be randomly assigned in a 1:1 ratio to either the EA group or the sham acupuncture (SA) group. Both groups will receive topical diclofenac emulgel (2 g per dose, twice daily) for 4 weeks, together with standardized education regarding PTAOA management. Participants in the EA and SA groups will receive 20 treatment sessions over 4 weeks. The primary outcome is the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS). Secondary outcomes include the Short-Form McGill Pain Questionnaire (SF-MPQ), Foot and Ankle Ability Measure (FAAM), 36-Item Short Form Health Survey (SF-36), musculoskeletal ultrasound findings, and serum levels of TNF-α, IL-6, and IL-1β. Clinical outcomes will be assessed at baseline, week 2, week 4, and week 8, while musculoskeletal ultrasound and serum inflammatory markers will be assessed at baseline and week 4. Discussion: This study will provide more comprehensive evidence regarding the efficacy and safety of EA combined with topical diclofenac emulgel for PTAOA and may help clarify its potential anti-inflammatory effects. Trial registration Registry: International Traditional Medicine Clinical Trial Registry (ITMCTR), No. ITMCTR2025001585; registered on 24 July 2025. Keywords: electroacupuncture, post-traumatic ankle osteoarthritis, diclofenac emulgel, TNF-α, IL-6, IL-1β