Abstract
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.
Highlights
Knee osteoarthritis (KOA) is one of the most common musculoskeletal disorders
Tu et al Trials (2019) 20:79 meta-analysis revealed that acupuncture was effective for the treatment of chronic pain, including osteoarthritis [12], whereas a recent high-quality randomised controlled trial suggested that neither laser nor needle acupuncture conferred a benefit over a sham treatment for pain or function in patients older than 50 years with moderate or severe KOA [13]
Primary outcome The primary outcome will be the success rate [25]: the proportion of patients achieving a minimal clinically important improvement (MCII) [13, 26], which is defined as ≥2 points on the numerical rating scale (NRS) and ≥6 points in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at week 8 compared with baseline
Summary
KOA is one of the most common musculoskeletal diseases and causes considerable financial burden for society This large trial will evaluate the efficacy of EA and MA versus SA in improving the symptoms of KOA. It is accepted that acupuncture is effective for the treatment of KOA compared with a blank control [12]. At the end of this trial, we hope the results will provide more reliable evidence and clarify the value of acupuncture as a treatment for KOA. Trial status This trial is currently recruiting patients. Additional file 1: Completed Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist.
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