International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Acupuncture-Moxibustion Department, Beijing Liangxiang Hospital, Beijing, China.
BMJ Open. 2024 Jan 24;14(1):e079709. doi: 10.1136/bmjopen-2023-079709.
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).
简介:膝骨关节炎是一种常见且使人丧失能力的疾病。针灸作为一种广泛应用于膝骨关节炎的临床治疗方法,已被证明可以改善疼痛并增强患者的关节功能。然而,目前缺乏比较不同疗程针灸治疗膝骨关节炎的证据。在这项试验中,我们将评估 4 周与 8 周针灸治疗膝骨关节炎患者的效果。
方法和分析:该方案是一项实用的、平行的、两臂随机对照试验,数据分析师和评估者均为盲法。将 148 名符合条件的膝骨关节炎患者以 1:1 的比例随机分配接受 4 周或 8 周的针灸治疗。电针治疗分别每周进行 3 次,持续 4 或 8 周。两组膝骨关节炎患者均随访至 26 周。主要结局是 26 周时的反应率,次要结局包括膝关节疼痛、膝关节功能、膝关节僵硬、生活质量、患者总体评估、骨关节炎研究协会国际反应率和急救药物。将进行 26 周的成本效益分析。
伦理和传播:该方案已获得北京中医药大学医学伦理委员会的批准(2023BZYL0506)。研究结果将通过在医学期刊上发表报告进行传播。此外,我们计划在选定的会议和科学会议上进行报告。
试验注册号:中国临床试验注册中心(ChiCTR2300073383;https://www.chictr.org.cn/showproj.html?proj=199310)。
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