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Open Access Highly Accessed Study protocol

Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial

Qinghui Que1, Xiaode Ye3, Quangui Su3, Yan Weng3, Jianfeng Chu2, Lijuan Mei2, Wenwen Huang3, Renhui Lu3 and Guohua Zheng2*

Author Affiliations

1 Affiliated Rehabilitation Hospital, Fujian University of Chinese Medicine, Fuzhou 350002, China

2 Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China

3 Rehabilitation Medicine College, Fujian University of Traditional Chinese Medicine, Fuzhou 350002, China

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Trials 2013, 14:186  doi:10.1186/1745-6215-14-186

Published: 22 June 2013

Abstract

Background

Neck pain caused by cervical spondylosis has become a common health problem worldwide among >40-year-old adults. Acupuncture intervention is one of the most popular treatment measures for this disorder. However, evidence for its efficacy in relieving neck pain and recovering neck physiological function has not been established in randomized, placebo-controlled trials. The primary aim of this trial is to assess the efficacy and safety of active acupuncture compared with sham acupuncture intervention for neck pain caused by cervical spondylosis.

Methods/Design

We will conduct a randomized, double-blind, parallel-group, placebo-controlled trial comparing active acupuncture with placebo (sham acupuncture). A total of 456 patients with neck pain caused by cervical spondylosis who meet the eligibility criteria from outpatient clinics of the Second People’s Hospital of Fujian Province and the Affiliated Rehabilitation Hospital, Fujian University of Traditional Chinese Medicine will be recruited and randomized into an active acupuncture or sham acupuncture group. The participants will undergo treatment sessions with either active or sham acupuncture intervention five times a week for 2 weeks. Evaluation by blinded assessors at baseline and at intervention for 1 and 2 weeks will include demographic characteristics, validated questionnaires (Northwick Park Neck Pain Questionnaire (NPQ) scale, Short-Form 36 (SF-36) scale, and McGill pain scale), examination of neck physiological function, and adverse events. All included patients will be followed up and investigated for relapse of neck pain at 4, 8, and 12 weeks after intervention.

Discussion

This paper describes the rationale and design of a randomized double-blind, placebo-controlled trial that aims to determine the efficacy and safety of acupuncture intervention for neck pain caused by cervical spondylosis. The primary outcomes are changes in the NPQ score and neck physiological function. Secondary outcome measures include quality of life, adverse events, and relapse of neck pain. If successful, this project will provide evidence of the efficacy and safety of acupuncture for neck pain caused by cervical spondylosis.

Trial registration

Chinese Clinical Trial Registry: ChiCTR-TRC-12002206.

Registration date: 11 May 2012.

Keywords:
Acupuncture; Efficacy and safety; Neck pain caused by cervical spondylosis; Randomized double-blind placebo-controlled trial