Mingcai Zhang1, Guoqing Du1, Congying Liu2, Wei Li3, Jiayu Yang4, Bo Chen1, Xiaoyue Yu3, Yizhe Xiong1, Enyu Jiang4, Ningyang Gao1, Sumin Jiang3, Zhenqiu Xu1, Xiang Wang1, Hongsheng Zhan5. 1. 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. 2. Shanghai University of TCM, Shanghai, People's Republic of China. 3. Jing'an District Central Hospital of Shanghai, Shanghai, People's Republic of China. 4. Xiangshan TCM Hospital, Huangpu District, Shanghai, People's Republic of China. 5. 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. 13524567258@139.com.
Abstract
BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: China Registered Clinical Trial Registration Center ChiCTR1900021371 . Registered on 17 February 2019.
RCT Entities:
BACKGROUND: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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: China Registered Clinical Trial Registration Center ChiCTR1900021371 . Registered on 17 February 2019.
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