Effectiveness And Safety of Acupotomy For Knee Osteoarthritis: Study Protocol For A Randomized Controlled Trial

Abstract

\n Background: Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Acupotomy may be effective for KOA, but evidence is limited. The aim of this trial is to determine the effectiveness and safety of acupotomy for KOA.Methods/design: This is a parallel-group, assessor-blinded randomized controlled trial. Two hundred patients with KOA will be recruited and randomly assigned to two groups (group A or group D) in a 1:1 ratio. Patients in group A will receive acupotomy and topical diclofenac diethylamine for 4 weeks, while patients in group D will receive topical diclofenac diethylamine alone for 4 weeks. The primary outcome will be the response rate—the proportion of patients who achieve the minimal clinically important improvement in pain and function at week 4 compared with baseline. Secondary outcomes will include pain, function, quality of life, the use of rescue medicine (loxoprofen sodium) and adverse events at weeks 4, 8 and 24 after randomization. Besides, joint fluid and serum will be collected to assess the level of inflammatory cytokines, like TNF-α, IL-1β and MMP-3.Discussion: This study will contribute to a better understanding of the effectiveness and safety of acupotomy in combination with topical nonsteroidal anti-inflammatory drugs. Results of the study will be of great importance for the guidelines of clinical therapy.Trial registration: Chinese Clinical Trial Registry (No. ChiCTR2100043005, http://www.chictr.org.cn/showproj.aspx?proj=121348) Registered on 4 February 2021.