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针刺后溪穴治疗落枕所致急性颈部疼痛:一项随机对照试验的研究方案

Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial.

作者信息

Sun Zhong-ren, Yue Jin-huan, Tian Hong-zhao, Zhang Qin-hong

机构信息

Department of Acupuncture and Moxibustion, College of Acupuncture and Moxibustion, Heilongjiang University of Chinese Medicine, Harbin, China Department of Acupuncture and Moxibustion, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.

Department of Acupuncture and Moxibustion, College of Acupuncture and Moxibustion, Heilongjiang University of Chinese Medicine, Harbin, China.

出版信息

BMJ Open. 2014 Dec 23;4(12):e006236. doi: 10.1136/bmjopen-2014-006236.

Abstract

INTRODUCTION

The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain.

METHODS/ANALYSIS: This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ).

ETHICS/DISSEMINATION: The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research.

TRIAL REGISTRATION NUMBER

ChiCTR-TRC-13003911.

摘要

引言

在中国,有人建议使用针灸治疗落枕引起的急性颈部疼痛。然而,目前的证据不足以就其疗效得出任何结论。因此,本初步研究旨在评估针刺后溪穴(SI3)治疗急性颈部疼痛的可行性和疗效。

方法/分析:本初步研究将是一项双平行组、评估者盲法、随机对照试验。将招募36名患有急性颈部疼痛的落枕参与者,并按1:1的比例随机分为两组。对照组的参与者将接受颈部局部按摩(每次5分钟,每天3次,共3天)。治疗组的患者除了接受按摩外,还将接受针灸治疗(每天1次,共3天)。将在第0、3和15天进行测量。主要结局指标是诺斯威克公园颈部疼痛问卷(NPQ)。次要结局指标是麦吉尔疼痛问卷简表(SF-MPQ)。

伦理/传播:本初步随机临床试验方案已通过伦理审查,并获得黑龙江中医药大学附属第一医院伦理审查委员会的批准(批准号:HZYLL201303502)。本研究结果将为针灸治疗落枕急性颈部疼痛患者的可行性和疗效提供重要的临床证据。此外,它将探索进一步开展针灸研究的可行性。

试验注册号

ChiCTR-TRC-13003911。

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