Li Wenxiong, Chang Yaxin, Feng Qi, Cheng Yan, Yin Jichao, Sun Yindi, Yang Feng
Shaanxi University of Chinese Medicine, Xi'an, 712000, China.
Affiliated Hospital of Shaanxi University of Chinese Medicine, Xi'an, 712083, China.
Contemp Clin Trials Commun. 2024 Jul 14;41:101323. doi: 10.1016/j.conctc.2024.101323. eCollection 2024 Oct.
To assess the clinical effectiveness of the balance chiropractic therapy (BCT) compared with traction therapy (TT) for patients with cervical spondylotic radiculopathy.
Subjects were enrolled from four hospitals. Eligible patients will be randomized to one of the two arms: the treatment group and the control group. In the treatment group, patients received the BCT for 20 days, while patients in the control group received TT. Patients visited the physician at 1- and 3-month follow-up. The primary outcome was pain severity measured with a Visual Analog Scale (VAS). Secondary outcomes included cervical curvature measured using the Borden method, 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.
Of the 240 randomly assigned patients, 120 participants were assigned to the BCT and 120 to the TT. 231 (96.3 %) provided follow-up data at 1 and 3 months. There were no significant differences in baseline data between the two groups (P > 0.05), indicating good comparability. According to the results, after BCT and TT treatment, the pain VAS score, cervical curvature, NDI scores and SF-36 scores of two groups was significantly improved (P < 0.05). Furthermore, at 20 days of treatment and 1 and 3 months of follow-up, the participants in the BCT group showed superior treatment outcomes on both primary and secondary measures.
The BCT may be a novel strategy for the treatment of the cervical spondylotic radiculopathy.
Clinical Trials.gov Identifier: NCT02705131. Registered on March 10, 2016, https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&rank=1&tab=table.
评估平衡整脊疗法(BCT)与牵引疗法(TT)治疗神经根型颈椎病患者的临床疗效。
研究对象来自四家医院。符合条件的患者将被随机分为两组:治疗组和对照组。治疗组患者接受20天的BCT治疗,而对照组患者接受TT治疗。患者在1个月和3个月随访时就诊。主要结局指标是使用视觉模拟量表(VAS)测量的疼痛严重程度。次要结局指标包括使用Borden方法测量的颈椎曲度、由颈部功能障碍指数(NDI)测量的功能状态综合指标、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)。
在240名随机分配的患者中,120名参与者被分配到BCT组,120名被分配到TT组。231名(96.3%)患者在1个月和3个月时提供了随访数据。两组之间的基线数据无显著差异(P>0.05),表明具有良好的可比性。根据结果,BCT和TT治疗后,两组的疼痛VAS评分、颈椎曲度、NDI评分和SF-36评分均显著改善(P<0.05)。此外,在治疗20天时以及1个月和3个月随访时,BCT组参与者在主要和次要指标上均显示出更好的治疗效果。
BCT可能是治疗神经根型颈椎病的一种新策略。
ClinicalTrials.gov标识符:NCT02705131。于2016年3月10日注册,https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&rank=1&tab=table。