Shi's Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of TCM, Institute of Traumatology & Orthopedics, Shanghai Academy of TCM, Shanghai, 201203, People's Republic of China.
Shanghai University of TCM, Shanghai, People's Republic of China.
Trials. 2021 Feb 8;22(1):123. doi: 10.1186/s13063-021-05062-6.
Neck pain is a common clinical disease, which seriously affects people's mental health and quality of life and results in loss of social productivity. Improving neck pain's curative effect and reducing its recurrence rate are major medical problems. Shi's manipulation therapy has unique advantages and technical features that aid in the diagnosis and treatment of neck pain. Compared with first-line non-steroidal anti-inflammatory drug (NSAID) treatment of neck pain, Shi's cervical manipulation lacks the relevant research basis of therapeutic advantage, safety, and satisfaction for treating acute and subacute neck pain. Herein, we aim to confirm our hypothesis in a clinical trial that the safety and efficacy of Shi's cervical manipulation will be more effective, safer, and more satisfactory than NSAIDs to treat acute and subacute neck pain.
In this multicenter, positive-controlled, randomized clinical trial, traditional analgesic drug (NSAID) is used to evaluate and show that Shi's manipulation is more effective, safe, and satisfactory for treating acute and subacute neck pain. Overall, 240 subjects are randomly divided into the trial and control groups, with both groups treated by the corresponding main intervention method for up to 12 weeks. Clinical data will be collected before the intervention and immediately after the first treatment; at 3 days and 1, 2, 4, 8, and 12 weeks after the intervention; and at 26 and 52 weeks after treatment follow-up of clinical observation index data collection. The clinical observation indices are as follows: (1) cervical pain is the primary observation index, measured by Numerical Rating Scale. The secondary indices include the following: (2) cervical dysfunction index, measured by patient self-evaluation using cervical Neck Disability Index; (3) cervical activity measurement, measured by the cervical vertebra mobility measurement program of Android mobile phone system; (4) overall improvement, measured by patient self-evaluation with SF-36; and (5) satisfactory treatment, determined by patient self-evaluation.
We will discuss whether Shi's cervical manipulation has greater advantages in efficacy, safety, and satisfaction of acute and subacute neck pain than traditional NSAIDs, to provide a scientific basis for the dissemination and application of Shi's cervical manipulation.
China Registered Clinical Trial Registration Center ChiCTR1900021371 . Registered on 17 February 2019.
颈痛是一种常见的临床疾病，严重影响人们的精神健康和生活质量，导致社会生产力丧失。提高颈痛的疗效，降低其复发率是主要的医学问题。史氏手法治疗具有独特的优势和技术特点，有助于颈痛的诊断和治疗。与一线非甾体抗炎药（NSAID）治疗颈痛相比，史氏颈椎手法缺乏治疗急性和亚急性颈痛的治疗优势、安全性和满意度相关研究基础。在此，我们旨在通过临床试验证实我们的假设，即史氏颈椎手法的安全性和疗效将比 NSAIDs 更有效、更安全、更能满足治疗急性和亚急性颈痛的需求。
本研究为多中心、阳性对照、随机临床试验，采用传统镇痛药物（NSAID）进行评估，证明史氏手法治疗急性和亚急性颈痛更有效、更安全、更满意。共纳入 240 例受试者，随机分为试验组和对照组，两组均采用相应的主要干预方法治疗，最长疗程 12 周。临床数据将在干预前和首次治疗后即刻、治疗后 3 天和 1、2、4、8、12 周以及治疗后随访的临床观察指标数据采集时收集。临床观察指标如下：（1）颈痛是主要观察指标，采用数字评分量表（NRS）测量。次要指标包括：（2）颈椎功能障碍指数，采用患者自评的颈椎颈部残疾指数（NDI）测量；（3）颈椎活动度测量，采用 Android 手机系统的颈椎椎体活动度测量程序测量；（4）总体改善，采用患者自评的 SF-36 测量；（5）满意治疗，由患者自评确定。
我们将讨论史氏颈椎手法治疗急性和亚急性颈痛的疗效、安全性和满意度是否优于传统 NSAIDs，为史氏颈椎手法的推广应用提供科学依据。
中国临床试验注册中心 ChiCTR1900021371，于 2019 年 2 月 17 日注册。
