Wu Nan, Huang Jin, Yang Xuguang, Guo Jian, Liu Feilai, Gu Yujing, Liu Yongtao, Zhang Zhenhua, Yin Shuai, Feng Xiaodong
School of Rehabilitation Medicine, Henan University of Chinese Medicine.
The Rehabilitation Center, First Affiliated Hospital of Henan University of Chinese Medicine.
Medicine (Baltimore). 2020 Oct 16;99(42):e22599. doi: 10.1097/MD.0000000000022599.
Whether there is the long-term effect of acupuncture on patients with knee osteoarthritis (KOA) or not is controversial. According to the basic theory of traditional acupuncture, deqi is the key to the efficacy of acupuncture. This randomized controlled trial aims to evaluate the existence of long-term effects caused by deqi in patients with KOA.
A three-armed, parallel-design, randomized controlled trial is underway in China.108 KOA patients recruited by the rehabilitation center of the First Affiliated Hospital of Henan University of Traditional Chinese Medicine will be randomly assigned to the acupuncture with deqi group (A group), the acupuncture without deqi group (B group) and the waiting-list group (C group). Each patient will receive 5 30-minute sessions per week for 4 consecutive weeks and rest for 2 days between treatments, and undergo a 20-week follow-up. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score). The secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis index (WOMAC score), Knee Injury and Osteoarthritis Outcome Score (KOOS), arthritis quality of life measurement scale simplified scale (AIMS2-SF), emotional monitoring and expectation scale. The pain visual analogue scale (VAS) and the Chinese version of modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MMASS) will be used to evaluate the deqi sensation after each acupuncture treatment. At the same time, adverse events (AEs) occurred in the whole process will be recorded and analyzed. We will perform an intention-to-treat analysis and protocol (PP) analysis to statistically analyze the results of the trial.
This trial will be useful to study the long-term effect of acupuncture and the influence of the deqi sensation on the long-term in the treatment of KOA, and to provide a clinical basis for treatment of patients with mild to moderate knee osteoarthritis in clinic.
Chinese Clinical Trial Registry, IDF: ChiCTR2000029291. Registered on January 21, 2020.
针刺对膝骨关节炎（KOA）患者是否具有长期疗效存在争议。根据传统针刺的基本理论，得气是针刺疗效的关键。本随机对照试验旨在评估得气对KOA患者是否存在长期效应。
一项三臂、平行设计的随机对照试验正在中国进行。河南中医药大学第一附属医院康复中心招募的108例KOA患者将被随机分配到得气针刺组（A组）、未得气针刺组（B组）和等待组（C组）。每位患者每周接受5次，每次30分钟的治疗，连续治疗4周，治疗期间休息2天，并进行20周的随访。主要结局指标是西安大略和麦克马斯特大学骨关节炎指数（WOMAC评分）。次要结局指标包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC评分）、膝关节损伤和骨关节炎疗效评分（KOOS）、关节炎生活质量测量量表简化版（AIMS2-SF）、情绪监测与期望量表。每次针刺治疗后，将使用疼痛视觉模拟量表（VAS）和中文版改良麻省总医院针刺感觉量表（C-MMASS）评估得气感觉。同时，记录并分析整个过程中发生的不良事件（AE）。我们将进行意向性分析和符合方案（PP）分析，对试验结果进行统计学分析。
本试验将有助于研究针刺的长期疗效以及得气感觉对KOA治疗长期疗效的影响，并为临床治疗轻至中度膝骨关节炎患者提供临床依据。
中国临床试验注册中心，IDF：ChiCTR2000029291。于2020年1月21日注册。
