School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
Department of Acupuncture-Moxibustion, Sunsimiao Hospital Affiliated to Beijing University of Chinese Medicine, Tongchuan, Shanxi, China.
BMJ Open. 2023 Aug 31;13(8):e068129. doi: 10.1136/bmjopen-2022-068129.
Mechanical neck pain (MNP) is defined as pain in the area of the neck and/or neck-shoulder provoked by body mechanics and which adversely affects physical, psychological and social function. The treatments for MNP are limited. Previous studies and clinical experience have indicated that myofascial acupuncture might be a better treatment option for MNP, but the efficacy is controversial. Therefore, our aim is to compare the efficacy of myofascial acupuncture and routine acupuncture for MNP.
The study is a multicentre, prospective randomised clinical trial. Patients will be recruited from four tertiary hospitals in China. A total of 438 participants with MNP will be randomly assigned into two groups, namely the 'Sancai-Tianbu' myofascial acupuncture group and the routine acupuncture group, at a ratio of 1:1. Each group will receive the acupuncture treatment twice a week for 21 days, totalling six sessions. The primary outcome will be the Visual Analogue Scale score. The secondary outcomes will be the Neck Disability Index, the cervical range of motion and the MOS 36-Item Short Form Health Survey. The assessments will be performed at baseline (immediately after allocation), pretreatment (5 min before every treatment), post-treatment (within 10 min after every treatment), postcourse (within 1 day after the course), and at 1, 3 and 6 months after the course. All patients will be included in the intent-to-treat analysis. Repeated-measure analysis of covariance will be used to determine the effects of the intervention on the outcome measures.
Ethics approval was obtained from China Aerospace Science & Industry Corporation 731 Hospital, with permission number 2022-0204-01. Written informed consent will be obtained from the enrolled patients. Trial results will be disseminated in peer-reviewed publications.
ChiCTR2200061453.
机械性颈部疼痛(MNP)是指因身体力学引起的颈部和/或颈肩部疼痛,并对身体、心理和社会功能产生不利影响。MNP 的治疗方法有限。既往研究和临床经验表明,肌筋膜针刺可能是 MNP 的更好治疗选择,但疗效存在争议。因此,我们旨在比较肌筋膜针刺和常规针刺治疗 MNP 的疗效。
该研究是一项多中心、前瞻性随机临床试验。将从中国的 4 家三级医院招募患者。共有 438 名 MNP 患者将被随机分为两组,即“三才天突”肌筋膜针刺组和常规针刺组,比例为 1:1。每组将接受每周两次的针刺治疗,共 21 天,共 6 次。主要结局指标为视觉模拟评分。次要结局指标为颈痛残疾指数、颈椎活动度和 MOS 36 项简明健康调查。评估将在基线(分配后立即)、治疗前(每次治疗前 5 分钟)、治疗后(每次治疗后 10 分钟内)、疗程后(疗程结束后 1 天内)和疗程后 1、3 和 6 个月进行。所有患者将纳入意向治疗分析。重复测量协方差分析将用于确定干预对结局指标的影响。
中国航天科工集团 731 医院已获得伦理批准,批准号为 2022-0204-01。将从纳入的患者中获得书面知情同意。试验结果将在同行评议的出版物中发表。
ChiCTR2200061453。