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首页> 外文期刊>Trials >The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial
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The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

机译：针刺治疗颈椎病引起的颈部疼痛的最佳方法：一项多中心随机对照试验的研究方案

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Background Neck pain is one of the chief symptoms of cervical spondylosis (CS). Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture versus placebo or non-classic acupuncture treatment and evaluate whether classic Chinese medical acupuncture is effective on CS neck pain. This study will provide evidence for the effects of acupuncture on CS neck pain. Trial Registration Chinese Clinical Trial Registry: ChiCTR-TRC-00000184.
机译：背景技术颈部疼痛是颈椎病（CS）的主要症状之一。针灸是一种广泛接受的辅助疗法，可用于治疗CS引起的颈部疼痛。在本文中，我们提出了一项随机对照试验方案，评估了针刺治疗CS颈部疼痛的效果，并与假手术和浅针刺疗法相比，将最佳针刺疗法的实际效果进行了比较。方法/设计本试验采用多中心，平行分组，随机，假针刺和浅针刺，可控的单盲设计。共有9家医院作为审判中心。 945名符合入选标准的患者通过计算机化的中央随机分配系统随机分配接受优化的针灸治疗，假针刺或浅针刺治疗。干预过去4周，总共进行了8到10次治疗。分组分配和干预对患者和统计人员隐藏。诺斯威克公园颈部疼痛问卷（NPQ）被用作主要结局指标，麦吉尔疼痛问卷（MPQ）和简表（36）健康调查（SF-36）被用作次要结局指标。在基线，干预结束时以及随访期间的第一个月和第三个月末进行评估。统计分析将包括基线数据比较和重复分析组和时间差异的主要和次要结果的方差分析（ANOVA）。如果发生不良事件（AE），则将进行报告。讨论该试验是一项针对针灸治疗CS颈部疼痛疗效的多中心随机对照试验（RCT），在中国具有较大的样本量和中心随机性。它将严格遵循CONSORT声明和STRICTA扩展指南，以报告高质量的研究结果。通过将对照组设置为假针刺和浅针刺，本研究试图揭示真正针刺与安慰剂或非经典针刺治疗的效果，并评估中医针灸对CS颈部疼痛是否有效。这项研究将提供针灸对CS颈部疼痛影响的证据。试验注册中国临床试验注册：ChiCTR-TRC-00000184。

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