Abstract
BackgroundAcupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence. This study is designed to determine the efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for KOA.Methods/designThis is a multi-center three-arm randomized controlled trial. It will enroll 480 participants with KOA in China. Participants will be randomly assigned 1:1:1 to receive 24 sessions of electro-acupuncture, manual acupuncture, or sham acupuncture over 8 weeks. The primary outcome is the response rate, which is the proportion of patients who achieve the minimal clinically important improvement in pain and function at 8 weeks. The primary outcome will be analyzed using the Z-test with the intention-to-treat set. Secondary outcomes include pain, function, global patient assessment, and quality of life. Full details of the statistical analysis plan for the primary and secondary outcomes will be described in this article. The statistical analysis plan was written and submitted without knowledge of the study data.DiscussionThe data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and to enhance the transparency of the trial. The aim of the trial is to provide high-quality evidence on the efficacy of acupuncture for KOA.Trial registrationClinicaltrials.gov, NCT03366363. Registered on 20 November 2017.
Highlights
Acupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence
The data will be analyzed according to this pre-specified statistical analysis plan to avoid data-driven analysis and to enhance the transparency of the trial
Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability in older adults [1], with symptomatic KOA affecting 8.1% of Chinese people [2] and 1.6–14.9% of Europeans according to age class [3]
Summary
Acupuncture is widely used for knee osteoarthritis (KOA), despite contradictory evidence. Acupuncture is increasingly used in clinical practice [9], evidence of its efficacy is contradictory [10, 11]. The dose of acupuncture administered in several previous trials was far from adequate [13]. The frequency of acupuncture is one of the key factors of a dose [14]. A review suggested that the frequency of acupuncture is usually three to five sessions per week in China, whereas it is mostly one session per week in Europe and America [15]. Based on our previous pilot trial [16], high-dose acupuncture
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