• Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, and Cun-Zhi Liu.
• School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Fengtai District, Beijing, China.
• Trials. 2019 Jan 25; 20 (1): 79.

BackgroundKnee osteoarthritis (KOA) is one of the most common musculoskeletal disorders. Although the available evidence for its efficacy is inconclusive, acupuncture is used as an alternative therapy for KOA. The aim of this trial is to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA.Methods/DesignThis is a study protocol for a randomised, three-arm, multicentre, clinical trial. A total of 480 patients with KOA will be randomly assigned to the electro-acupuncture group, the manual acupuncture group or the sham acupuncture group in a 1:1:1 ratio. All patients will receive 24 sessions over 8 weeks. Participants will complete the trial by visiting the research centre at week 26 for a follow-up assessment. The primary outcome is the success rate: the proportion of patients achieving a minimal clinically important improvement, which is defined as ≥2 points on the numerical rating scale and ≥6 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline. Secondary outcomes include the numerical rating scale, WOMAC score, global patient assessment and quality of life at weeks 4, 8, 16 and 26 after randomisation.DiscussionThis trial may provide high-quality evidence for the efficacy of acupuncture in the treatment of KOA. The results of this study will be published in peer-reviewed journals.Trial RegistrationClinicalTrials.gov, NCT03274713 . Registered on 20 November 2017.

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