针刺、电针和温针治疗膝骨关节炎的疗效：一项随机对照试验的研究方案。
Efficacy of manual acupuncture, electro-acupuncture, and warm acupuncture for knee osteoarthritis: study protocol for a randomized controlled trial.
机构信息
Henan University of Chinese Medicine, No. 156 East Jinshui Road, Zhengzhou, Henan, China.
Department of Rehabilitation, The First Affiliated Hospital of Henan University of Chinese Medicine, No. 19 Renmin Road, Zhengzhou, Henan, China.
出版信息
Trials. 2022 Aug 20;23(1):700. doi: 10.1186/s13063-022-06653-7.
BACKGROUND
Acupuncture is one of the most popular complementary and alternative treatments for knee osteoarthritis (KOA). There are many methods of acupuncture in the treatment of KOA, and the effects are different. According to our clinical observations and researches, it is found that manual acupuncture (MA), electro-acupuncture (EA), and warm acupuncture (WA) are used more frequently in the treatment of KOA, and the curative effects are satisfactory. However, there is currently a lack of efficacy comparison of efficacy between different acupuncture treatments, as well as a lack of standardized clinical research on the acupuncture treatment of KOA. Therefore, we will carry out a high-quality clinical randomized controlled trial to research the effect laws of MA, EA, and WA on KOA.
METHODS/DESIGN: A total of 200 eligible participants with KOA will be randomly assigned to group A, B, C, or D in a ratio of 1:1:1:1. Patients in group A will receive MA, while those in group B, group C, and group D will be treated with EA, WA, and sham acupuncture (SA), respectively. Patients will be treated with acupuncture once a day, 30 min per session, 5 sessions per week for 4 weeks. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at week 4. The secondary outcomes include WOMAC, visual analog scale (VAS), Arthritis Quality of Life Measurement Scale Simplified Scale (AIMS2-SF), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Credibility/Expectancy Questionnaire. The evaluation will be performed at baseline and weeks 4, 8, and 12 respectively after randomization.
DISCUSSION
This is a randomized controlled trial. We will observe the clinical effect of MA, EA, and WA on KOA to research the effect laws of these three acupuncture treatments on KOA and set up standardized treatment programs for acupuncture for KOA.
TRIAL REGISTRATION
China Clinical Trials Registry ChiCTR2100049526. Registered on August 2, 2021.
背景
针灸是治疗膝骨关节炎（KOA）最常用的补充和替代疗法之一。在治疗 KOA 中，有许多种针灸方法，其效果也不同。根据我们的临床观察和研究，发现手动针灸（MA）、电针（EA）和温针灸（WA）在治疗 KOA 中应用更为广泛，疗效满意。但是，目前缺乏不同针灸治疗方法疗效的比较，也缺乏 KOA 针灸治疗的规范化临床研究。因此，我们将开展一项高质量的临床随机对照试验，研究 MA、EA 和 WA 对 KOA 的疗效规律。
方法/设计：将 200 例符合条件的 KOA 患者按照 1:1:1:1 的比例随机分为 A、B、C、D 四组。A 组患者接受 MA，B 组、C 组和 D 组患者分别接受 EA、WA 和假针刺（SA）治疗。患者每天接受针刺治疗，每次 30 分钟，每周 5 次，共 4 周。主要结局是第 4 周时的西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）的变化。次要结局包括 WOMAC、视觉模拟评分（VAS）、关节炎生活质量测量简化量表（AIMS2-SF）、贝克焦虑量表（BAI）、贝克抑郁量表（BDI）和可信度/期望问卷。在随机分组后第 4、8、12 周分别进行评估。
讨论
这是一项随机对照试验。我们将观察 MA、EA 和 WA 对 KOA 的临床疗效，研究这三种针灸疗法对 KOA 的疗效规律，为 KOA 的针灸治疗制定规范化治疗方案。
试验注册
中国临床试验注册中心 ChiCTR2100049526。注册于 2021 年 8 月 2 日。
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