Randomised comparative effectiveness trial evaluating the efficacy and safety of acupuncture-related integrative therapy combined with celecoxib for chronic pain in patients with knee osteoarthritis: protocol.

چکیده اصلی

INTRODUCTION: Knee osteoarthritis (KOA) is a prevalent chronic degenerative joint disorder that seriously affects mobility and quality of life in older adults. Pharmacological treatments such as celecoxib are commonly used for symptom relief, but their long-term use may be limited by adverse effects. Acupuncture has been widely used as a complementary non-pharmacological treatment for KOA and may help reduce pain and improve function; however, its onset of benefit may be relatively gradual. Combining acupuncture-related integrative therapy with celecoxib may provide more rapid symptom relief while potentially improving sustained clinical outcomes and reducing reliance on prolonged pharmacological treatment. This study aims to evaluate the comparative effectiveness and safety of acupuncture-related integrative therapy, celecoxib and their combination in patients with KOA in a multicentre randomised controlled trial. METHODS AND ANALYSIS: This is a multicentre, three-arm, parallel-group randomised controlled trial that will be conducted in three hospitals in Hunan Province, China. A total of 282 participants with KOA will be randomly assigned in a 1:1:1 ratio to receive acupuncture-related integrative therapy, celecoxib therapy or combined acupuncture-related integrative therapy and celecoxib for 4 weeks, with an additional 4-week follow-up period. The primary outcome is the change in Visual Analogue Scale score for activity-related knee pain from baseline to week 4. Secondary outcomes include the Western Ontario and McMaster Universities Osteoarthritis Index, clinical response rate, knee range of motion, 30-second chair-stand test, 40-metre fast-paced walk test and incidence of adverse events. Outcome assessments will be conducted at baseline, week 2, week 4 and week 8. Safety will be monitored throughout. Data will be analysed using the intention-to-treat principle. ETHICS AND DISSEMINATION: The study has been approved by the ethics committees of all centres (HN-LL-KY-2025-007-01, 2025-KY-019-01, 2025042705). The study findings will be disseminated through publication in peer-reviewed journals and presentations at national or international academic conferences. TRIAL REGISTRATION NUMBER: ITMCTR2026000093. Registered on 5 December 2025. The first participant was recruited on 27 February 2026.

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