治疗颈椎根性病变的平衡整脊疗法:随机对照试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-07-14 DOI:10.1016/j.conctc.2024.101323
Wenxiong Li , Yaxin Chang , Qi Feng , Yan Cheng , Jichao Yin , Yindi Sun , Feng Yang
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引用次数: 0

摘要

目的 评估平衡整脊疗法(BCT)与牵引疗法(TT)对颈椎根性病变患者的临床疗效。符合条件的患者将被随机分为两组:治疗组和对照组。治疗组患者接受为期 20 天的 BCT 治疗,而对照组患者则接受 TT 治疗。患者在 1 个月和 3 个月的随访中接受医生的检查。主要结果是用视觉模拟量表(VAS)测量疼痛的严重程度。次要结果包括使用 Borden 方法测量的颈椎曲度、使用颈部残疾指数(NDI)测量的功能状态综合指数、患者健康状况(通过 SF-36 健康调查进行评估)以及试验报告的不良事件(AEs)。231人(96.3%)提供了1个月和3个月的随访数据。两组患者的基线数据无明显差异(P> 0.05),具有良好的可比性。结果显示,经过 BCT 和 TT 治疗后,两组患者的疼痛 VAS 评分、颈椎曲度、NDI 评分和 SF-36 评分均有明显改善(P < 0.05)。此外,在治疗20天、随访1个月和3个月时,BCT组的参与者在主要和次要指标上都显示出了更优越的治疗效果。试验注册Clinical Trials.gov Identifier:NCT02705131。注册时间:2016年3月10日,https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&rank=1&tab=table。
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Balance chiropractic therapy for cervical spondylotic radiculopathy: A randomized controlled trial

Objective

To assess the clinical effectiveness of the balance chiropractic therapy (BCT) compared with traction therapy (TT) for patients with cervical spondylotic radiculopathy.

Methods

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.

Results

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.

Conclusion

The BCT may be a novel strategy for the treatment of the cervical spondylotic radiculopathy.

Trial registration

Clinical Trials.gov Identifier: NCT02705131. Registered on March 10, 2016, https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&rank=1&tab=table.

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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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