Electroacupuncture versus exercise in patients with knee osteoarthritis: Study protocol for a randomized controlled trial.

PURPOSE: Knee osteoarthritis (KOA) is a common disorder among middle and older individuals. Electroacupuncture and exercise are present as two popular physical therapies for the management of KOA, and both were demonstrated to produce considerable results. However, the clinical decision-making process between these therapeutic interventions remains challenging due to the limited evidence of distinctions in their respective effects. This study aims to evaluate the clinical effect and cost effectiveness of electroacupuncture versus exercise in patients with KOA. STUDY DESIGN AND METHODS: This is a randomized controlled trial in which 196 symptomatic KOA patients will be randomly assigned 1:1 either to the electroacupuncture group (n = 98) and the exercise group (n = 98). Patients in the electroacupuncture group will receive acupuncture with electric stimulation 3 times a week for 8 weeks, whereas patients in the exercise group will receive neuromuscular training twice a week for 8 weeks. Education concerning KOA management will be provided in both therapies. Co-primary outcomes include changes in numerical rating scale (NRS) and Knee injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) subscale from baseline at week 8. Secondary outcomes include KOOS Pain subscale, KOOS knee-related Quality of Life (QOL) subscale, Short Form 6 Dimensions (SF-6D), five-level EuroQol five-dimensional questionnaire (EQ-5D-5L), Credibility/ Expectancy Questionnaire, Patient's global assessment (PGA), 30-second Chair Stand Test (30s-CST), 40m (4*10m) Fast Paced Walk Test (40m FPWT), and Daily Physical Activity level (DPA). DISCUSSION: The results of this study will provide evidence regarding differences between these 2 physical therapies in multiple aspects and will provide specific guidance for the development of treatments based on the needs of individual patients. TRIAL REGISTRATION: ChiCTR2300070376.

Effect of 4 weeks vs 8 weeks of acupuncture for knee osteoarthritis in China: protocol for a randomised controlled trial.

INTRODUCTION: Knee osteoarthritis represents the prevalent and incapacitating disease. Acupuncture, a widely used clinical treatment for knee osteoarthritis, has been shown to ameliorate pain and enhance joint function in affected individuals. However, there is a lack of evidence comparing different courses of acupuncture for knee osteoarthritis. In this trial, we will assess the effect of 4 weeks vs 8 weeks of acupuncture in patients with knee osteoarthritis. METHODS AND ANALYSIS: The protocol is a pragmatic, parallel, two-arm randomised controlled trial, with the data analyst and assessor being blinded. 148 eligible patients with knee osteoarthritis will be randomly allocated in a 1:1 ratio to receive 4-week or 8-week acupuncture. Electroacupuncture will be administered three times per week for 4 or 8 weeks, respectively. Patients with knee osteoarthritis in both groups will be followed up to 26 weeks. The primary outcome is the response rate at week 26, and secondary outcomes include knee joint pain, knee joint function, knee joint stiffness, quality of life, patient global assessment, the Osteoarthritis Research Society International response rate and rescue medicine. A cost-effectiveness analysis will be carried out over 26 weeks. ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethical Committee of Beijing University of Chinese Medicine (2023BZYL0506). The study findings will be disseminated through presentation in a medical journal. Additionally, we plan to present them at selected conferences and scientific meetings. TRIAL REGISTRATION NUMBER: Chinese Clinical Trials Registry (ChiCTR2300073383; https://www.chictr.org.cn/showproj.html?proj=199310).