Yang Feng, Li Wen-Xiong, Liu Zhu, Liu Li
Shaanxi University of Chinese Medicine, Xi'an, 712000, China.
Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, 712083, China.
Trials. 2016 Oct 22;17(1):513. doi: 10.1186/s13063-016-1644-2.
Cervical spondylosis is a very common disorder and cervical spondylotic radiculopathy (CSR) is the most common form of spinal degenerative disease. Its clinical manifestations focus on pain and numbness of the neck and arm as well as restricted movement of the neck, which greatly affect the patient's life and work. The orthopedic of traditional Chinese medicine (TCM) theory holds that the basic pathologic change in spinal degenerative diseases is the imbalance between the dynamic system and the static system of the cervical spine. Based on this theory, some Chinese physicians have developed a balance chiropractic therapy (BCT) to treat CSR, which has been clinically examined for more than 50 years to effectively cure CSR. The purpose of this study is to evaluate the therapeutic effect and safety of BCT on CSR and to investigate the mechanism by which the efficacy is achieved.
METHODS/DESIGN: We propose a multicenter, parallel-group, randomized controlled trial to evaluate the efficacy and safety of BCT for CSR. Participants aged 18 to 65 years, who are in conformity with the diagnostic criteria of CSR and whose pain score on a Visual Analog Scale (VAS) is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: a treatment group and a control group. Participants in the treatment group will be treated with BCT, while the control group will receive traction therapy (TT). The primary outcome is pain severity (measured with a VAS). Secondary outcomes will include cervical curvature (measured by the Borden Index), a composite of functional status (measured by the Neck Disability Index, NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial.
If BCT can relieve neck pain without adverse effects, it may be a novel strategy for the treatment of CSR. Furthermore, the mechanism of BCT for CSR will be partially elucidated.
Clinical Trials.gov Identifier: NCT02705131 . Registered on 9 March 2016.
颈椎病是一种非常常见的疾病，神经根型颈椎病（CSR）是脊柱退行性疾病最常见的形式。其临床表现主要为颈部和手臂疼痛、麻木以及颈部活动受限，这极大地影响了患者的生活和工作。中医正骨理论认为，脊柱退行性疾病的基本病理变化是颈椎动力系统与静力系统失衡。基于这一理论，一些中医医师研发了平衡整脊疗法（BCT）来治疗CSR，该疗法已历经50多年的临床检验，能有效治愈CSR。本研究旨在评估BCT治疗CSR的疗效和安全性，并探究其疗效达成的机制。
方法/设计：我们提议开展一项多中心、平行组、随机对照试验，以评估BCT治疗CSR的疗效和安全性。年龄在18至65岁之间、符合CSR诊断标准且视觉模拟量表（VAS）疼痛评分大于4分且小于8分的参与者将被纳入研究，并随机分为两组：治疗组和对照组。治疗组参与者将接受BCT治疗，而对照组将接受牵引治疗（TT）。主要结局指标是疼痛严重程度（用VAS测量）。次要结局指标将包括颈椎曲度（用Borden指数测量）、功能状态综合指标（用颈部功能障碍指数，NDI测量）、患者健康状况（通过SF-36健康调查评估）以及试验中报告的不良事件（AE）。
如果BCT能够缓解颈部疼痛且无不良反应，那么它可能是一种治疗CSR的新策略。此外，BCT治疗CSR的机制将得到部分阐明。
ClinicalTrials.gov标识符：NCT02705131。于2016年3月9日注册。
