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

Researchers are studying whether electroacupuncture combined with a topical pain gel can help people with post-traumatic ankle osteoarthritis (PTAOA), a chronic condition that develops after an ankle injury and causes ongoing pain and difficulty with daily activities. This study will involve 78 patients who will be divided into two groups: one receiving real electroacupuncture and another receiving sham (fake) acupuncture. Both groups will apply diclofenac gel to their ankles twice daily and receive education about managing their condition. The electroacupuncture group will have needles inserted at specific points with mild electrical stimulation, while the sham group will have a similar experience without actual needle penetration or electrical current. Treatments will occur over four weeks, with 20 sessions total. Researchers will measure pain levels, ankle function, quality of life, and inflammatory markers in the blood at multiple time points. They'll also use ultrasound imaging to look at changes in the ankle joint. This is a study protocol, meaning the research is planned but results are not yet available. If the study shows electroacupuncture provides additional benefits beyond the topical gel alone, it could offer patients with ankle arthritis a safe, drug-free option to reduce pain and improve function. The researchers are particularly interested in understanding whether electroacupuncture works by reducing inflammation in the joint. Once completed, this trial may help clarify whether combining electroacupuncture with standard topical treatments is more effective than medication alone for this debilitating condition. If you're considering acupuncture for ankle arthritis, consult with a licensed acupuncturist experienced in treating musculoskeletal conditions.

This randomized, sham-controlled superiority trial will evaluate electroacupuncture (EA) combined with topical diclofenac emulgel for post-traumatic ankle osteoarthritis (PTAOA). Seventy-eight patients will be randomized 1:1 to EA or sham acupuncture (SA), with both groups receiving diclofenac emulgel (2g twice daily) and standardized education for 4 weeks. Participants will receive 20 treatment sessions over the study period. The primary outcome measure is the AOFAS Ankle-Hindfoot Scale. Secondary outcomes include SF-MPQ, FAAM, SF-36, musculoskeletal ultrasound findings, and serum inflammatory markers (TNF-α, IL-6, IL-1β). Assessments occur at baseline, weeks 2, 4, and 8 for clinical outcomes, with ultrasound and inflammatory markers measured at baseline and week 4. This protocol aims to provide high-quality evidence for EA efficacy in PTAOA and explore anti-inflammatory mechanisms. The study design addresses the current evidence gap for non-pharmacological interventions in this chronic condition, with results potentially informing integrative treatment protocols.