Acupuncture treatment for knee osteoarthritis with sensitive points: protocol for a multicentre randomised controlled trial

作者：Li Tang, Pengli Jia, Ling Zhao, Deying Kang, Yanan Luo, Jiali Liu, Ling Li, Hui Zheng, Ying Li, Ning Li, Gordon Guyatt, Xin Sun · 发表于：BMJ Open · 年份：2018 · DOI：10.1136/bmjopen-2018-023838 · 被引用次数：27 · 研究领域：Acupuncture Treatment Research Studies、Traditional Chinese Medicine Studies、Complementary and Alternative Medicine Studies

INTRODUCTION: There is a lack of curative medical treatment for patients with knee osteoarthritis (KOA). Acupuncture represents an important alternative therapy. According to the theory of traditional Chinese medicine and preliminary clinical evidence, the patients' acupoints and tender points may become sensitised when the body suffers from a disease state; stimulation of such sensitive points could lead to a disease improvement. It is thus hypothesised that acupuncture at highly sensitised points on patients with KOA would achieve better treatment outcomes than acupuncture at low/non-sensitised points. Previously, we conducted a pilot trial to prove the feasibility of further investigation. METHODS AND ANALYSIS: A three-arm, parallel, multicentre randomised controlled trial of 666 patients will be conducted at four hospitals of China. Eligible patients with KOA who consent to participate will be randomly assigned to a high-sensitisation group (patients receive acupuncture treatment at high-sensitive points), a low/non-sensitisation group (patients receive acupuncture treatment at low/non-sensitive points) or a waiting-list group (patients receive standard acupuncture treatment after the study is concluded) via a central randomisation system using 1:1:1 ratio. The primary outcome is the change of Western Ontario and McMaster Universities Osteoarthritis Index total score from baseline to 16 weeks. Outcome assessors and data analysts will be blinded and participants will be as...