Abstract
BACKGROUND: Acupuncture has been used to relieve chronic pain in patients with knee osteoarthritis (KOA), but the evidence is contradictory. Therefore, we carefully designed a double-dummy randomized controlled trial (RCT) to explore the therapeutic effect of acupuncture for KOA. METHODS/DESIGN: A total of 138 eligible participants with KOA who consent to participate will be randomly divided into Groups A, B, and C in a ratio of 1:1:1. Participants in Group A will receive verum acupuncture and placebo gel, while those in Groups B and C will be treated with diclofenac diethylammon gel and sham acupuncture, sham acupuncture and placebo gel, respectively. The patients will receive 4 weeks of treatment, five times a week, including acupuncture treatment once a day for 30 min and gel treatment three times a day. The primary outcome will be the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes will include visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline, week 4, 8, and 12 after randomization. DISCUSSION: This double-dummy RCT used diclofenac diethylammon gel as a positive control, and the completion of this trial will provide detailed and accurate evidence of the efficacy and safety of acupuncture for KOA. TRIAL REGISTRATION: China Clinical Trials Registry No.ChiCTR2100043947. Registered on September 24, 2020. https://www.chictr.org.cn/showproj.html?proj=122536 .