Department of Orthopaedics, Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Graduate School, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
BMJ Open. 2019 Apr 8;9(4):e026084. doi: 10.1136/bmjopen-2018-026084.
The purpose of this study is to assess the efficacy of electroacupuncture (EA) to relieve pain and promote functional rehabilitation after total knee surgery.
We propose a single-blinded, randomised placebo-controlled trial to evaluate the efficacy of EA. Patients with osteoarthritis (aged 55-80 years) undergoing unilateral total knee arthroplasty (TKA) will be included in the trial. They will be randomised to receive either EA or sham-EA. A total of 110 patients will receive EA and sham-EA for 3 days after TKA. Postoperative pain will be measured using visual analogue score, and the need for an additional dose of opioid and analgesics will be recorded as the primary outcome. Secondary outcomes include knee function and swelling, postoperative anxiety, postoperative nausea and vomiting among other complications.
This study has been approved by the ethics committee, and subsequent modifications of the protocol will be reported and approved by it. Written informed consent will be obtained from all of the participants or their authorised agents.
ChiCTR1800016200; Pre-results.
本研究旨在评估电针(EA)在全膝关节手术后缓解疼痛和促进功能康复的效果。
我们提出了一项单盲、随机安慰剂对照试验来评估 EA 的疗效。该试验将纳入接受单侧全膝关节置换术(TKA)的骨关节炎患者(年龄 55-80 岁)。他们将被随机分配接受 EA 或假 EA。共有 110 例患者将在 TKA 后接受 EA 和假 EA 治疗 3 天。术后疼痛将采用视觉模拟评分(VAS)进行测量,需要额外使用阿片类药物和镇痛药的情况将作为主要结局进行记录。次要结局包括膝关节功能和肿胀、术后焦虑、术后恶心和呕吐等并发症。
本研究已获得伦理委员会的批准,方案的后续修改将报告并获得其批准。所有参与者或其授权代理人将获得书面知情同意。
ChiCTR1800016200;预注册结果。