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基于膝骨关节炎的针刺特异性和非特异性效应的大脑机制：一项随机对照试验的研究方案。

The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial.

机构信息

School of Acupuncture-Moxibustion and Tuina, Shandong University of Chinese Medicine, Jinan, Shandong, China.

Acupuncture Research Center, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.

出版信息

Trials. 2020 Jun 23;21(1):566. doi: 10.1186/s13063-020-04518-5.

DOI:10.1186/s13063-020-04518-5
PMID:32576243
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7310547/
Abstract

BACKGROUND

Research on the effect of acupuncture has been limited. Whether the effect of acupuncture is equivalent to placebo has been the focus of debate in this field. This study will explore the specific and non-specific effects of acupuncture for knee osteoarthritis (KOA) by functional magnetic resonance imaging (fMRI).

METHODS AND DESIGN

Ninety participants diagnosed with KOA will be randomly divided into the acupuncture group, sham acupuncture group, and waiting list group in a ratio of 1:1:1. Except for the waiting list group, the other participants will receive acupuncture or sham acupuncture three sessions per week for 4 weeks respectively. The primary outcome will be the response rate which is defined on an individual basis as at least a 2-point decrease in the numerical rating scale (NRS) of pain at the end of intervention period compared with the baseline. fMRI scans will be performed at baseline and the end of the intervention period to examine the response of various brain regions. The secondary outcomes will include the Western Ontario and McMaster Osteoarthritis Index (WOMAC), State-Trait Anxiety Scale-State Anxiety Subscale (STAI-S), and Stanford Expectations of Treatment Scale (SETS). Pearson's correlation coefficient will be performed to investigate the changes in brain activity and clinical variables.

DISCUSSION

The results of our study will help to evaluate the specific and nonspecific effects of acupuncture combined with clinical and brain function changes based on KOA.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR1900025799. Registered on 9 September 2019.

摘要

背景

针灸疗效的研究一直受到限制。针灸的疗效是否等同于安慰剂一直是该领域争论的焦点。本研究将通过功能磁共振成像（fMRI）探讨针灸治疗膝骨关节炎（KOA）的特异性和非特异性效应。

方法与设计

90 名 KOA 患者将按照 1:1:1 的比例随机分为针灸组、假针灸组和等待名单组。除等待名单组外，其他组患者每周接受 3 次针灸或假针灸治疗，共 4 周。主要结局指标为个体的反应率，即在干预期末与基线相比，疼痛数字评分量表（NRS）至少降低 2 分。基线和干预期末将进行 fMRI 扫描，以检查不同脑区的反应。次要结局指标包括西部安大略省和麦克马斯特大学骨关节炎指数（WOMAC）、状态-特质焦虑量表-状态焦虑分量表（STAI-S）和斯坦福治疗期望量表（SETS）。将进行 Pearson 相关系数分析，以探讨脑活动和临床变量的变化。

讨论

我们的研究结果将有助于评估基于 KOA 的针灸联合临床和脑功能变化的特异性和非特异性效应。

试验注册

中国临床试验注册中心 ChiCTR1900025799。注册于 2019 年 9 月 9 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1967/7310547/02963dd826ab/13063_2020_4518_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1967/7310547/e07a5053ba99/13063_2020_4518_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1967/7310547/e07a5053ba99/13063_2020_4518_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1967/7310547/c3b453518a6e/13063_2020_4518_Fig2_HTML.jpg
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