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针刺治疗颈痛患者的疗效及中枢机制:一项随机对照试验研究方案。

Efficacy and central mechanism of acupuncture treatment in patients with neck pain: study protocol for a randomized controlled trial.

机构信息

Brain Research Center, Acupuncture and Tuina School/The 3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37# Shierqiao Road, Chengdu, 610075, Sichuan, China.

Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610072, Sichuan, China.

出版信息

Trials. 2021 Aug 14;22(1):536. doi: 10.1186/s13063-021-05507-y.

Abstract

BACKGROUND

Acupuncture is effective for reducing the symptoms of neck pain (NP). However, the underlying mechanisms are not fully elucidated. Based on evaluating the efficacy of two acupuncture prescriptions for treating NP, this study aims to investigate the potential central mechanism of acupuncture treatment for NP by functional magnetic resonance imaging (fMRI).

METHODS

This is a randomized controlled trial; 86 patients will be randomly assigned into two acupuncture treatment groups at a ratio of 1:1. The whole study period includes 2 weeks baseline, 2 weeks treatments, and 12 weeks follow-up (4 and 12 weeks after treatment). The pain severity, the neck disability index, the cervical range of motion, and the pressure pain threshold, etc., will be used to evaluate the clinical efficacy of two acupuncture prescriptions for NP treatment. The MRI scans will be performed to detect cerebral activity changes of 20 patients in each group. The clinical data and MRI data will be analyzed, respectively. Pearson correlation coefficient will be used to evaluate the association between changes of cerebral activity features and improvement of clinical symptoms.

DISCUSSION

The results will provide further evidence for the clinical application of acupuncture in the treatment of NP.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2000040930 . Registered on 16 December 2020.

摘要

背景

针刺对于缓解颈痛(NP)的症状是有效的。然而,其潜在的机制尚未完全阐明。本研究通过功能磁共振成像(fMRI)来评价两种针刺方案治疗 NP 的疗效,旨在探讨针刺治疗 NP 的潜在中枢机制。

方法

这是一项随机对照试验;86 例患者将以 1:1 的比例随机分为两组接受针刺治疗。整个研究周期包括 2 周的基线期、2 周的治疗期和 12 周的随访期(治疗后 4 周和 12 周)。采用疼痛严重程度、颈痛残疾指数、颈椎活动度和压痛阈等来评价两种针刺方案治疗 NP 的临床疗效。对每组 20 例患者进行 MRI 扫描,以检测大脑活动变化。将对临床数据和 MRI 数据分别进行分析。Pearson 相关系数将用于评估大脑活动特征的变化与临床症状改善之间的关联。

讨论

研究结果将为针刺治疗 NP 的临床应用提供进一步的证据。

试验注册

中国临床试验注册中心 ChiCTR2000040930 。注册于 2020 年 12 月 16 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b188/8364082/d788b1b28577/13063_2021_5507_Fig1_HTML.jpg

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