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推拿治疗伴有焦虑的慢性下腰痛的疗效:一项随机对照试验的研究方案。

Efficacy of Tuina in chronic low back pain with anxiety: study protocol for a randomised controlled trial.

机构信息

School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital, Shanghai, People's Republic of China.

出版信息

BMJ Open. 2023 Oct 19;13(10):e073671. doi: 10.1136/bmjopen-2023-073671.

DOI:10.1136/bmjopen-2023-073671
PMID:37857544
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10603401/
Abstract

INTRODUCTION

Chronic low back pain (cLBP) is one of the largest and most frequent public health problems worldwide. Tuina is a physical therapy commonly used in China to treat musculoskeletal diseases. Compared with traction, there is little high-quality scientific evidence that can demonstrate the effectiveness of Tuina in the treatment of patients with cLBP. Therefore, the purpose of this clinical trial is to evaluate the effect of massage on cLBP patients compared with traction.

METHODS AND ANALYSES

This is a single-centre, assessor-blinded and analyst-blinded prospective randomised controlled trial with two parallel arms. Ninety-four patients with cLBP will be recruited. Three treatments were given every week for a total of 4 weeks. In the Traction group, participants were given traction therapy in the Tuina group, participants will receive a four-step physiotherapy including kneading, rolling, plucking and oblique pulling. The outcomes will be measured at baseline, at the end of treatment, as well as 1 and 2 months after treatment. The primary outcome will be the Hamilton Anxiety Scale after 12 sessions of treatment. The secondary outcomes will be the Visual Analogue Scale, the medical outcomes study Short Form 36, Serum Quantitative Index and genetic testing after 12 sessions of treatment.

ETHICS AND DISSEMINATION

The study was approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated with Shanghai University of Traditional Chinese Medicine.

TRIAL REGISTRATION NUMBER

ChiCTR2200065448.

摘要

简介

慢性下腰痛(cLBP)是全球最大和最常见的公共卫生问题之一。推拿是一种在中国常用于治疗肌肉骨骼疾病的物理疗法。与牵引相比,很少有高质量的科学证据可以证明推拿在治疗慢性下腰痛患者中的有效性。因此,本临床试验的目的是评估与牵引相比,按摩对慢性下腰痛患者的治疗效果。

方法和分析

这是一项单中心、评估者盲法和分析者盲法的前瞻性随机对照试验,采用两平行臂设计。将招募 94 名慢性下腰痛患者。每周进行 3 次治疗,共 4 周。在牵引组中,参与者接受牵引治疗;在推拿组中,参与者将接受包括揉捏、滚压、弹拨和斜拉在内的四步物理疗法。在基线、治疗结束时以及治疗后 1 个月和 2 个月时测量结局。主要结局将是治疗 12 次后的汉密尔顿焦虑量表。次要结局将是视觉模拟量表、医疗结局研究简表 36、血清定量指数和治疗 12 次后的基因检测。

伦理和传播

本研究已获得上海中医药大学附属岳阳中西医结合医院伦理委员会的批准。

注册号

ChiCTR2200065448。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/4812da53db64/bmjopen-2023-073671f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/4d50ae2a72ef/bmjopen-2023-073671f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/fde9a555706d/bmjopen-2023-073671f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/4812da53db64/bmjopen-2023-073671f03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/4d50ae2a72ef/bmjopen-2023-073671f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/fde9a555706d/bmjopen-2023-073671f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/414c/10603401/4812da53db64/bmjopen-2023-073671f03.jpg

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