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

Trials

Guohua Zheng²  Renhui Lu¹  Wenwen Huang¹  Lijuan Mei²  Jianfeng Chu²  Yan Weng¹  Quangui Su¹  Xiaode Ye¹  Qinghui Que³ 

[1] Rehabilitation Medicine College, Fujian University of Traditional Chinese Medicine, Fuzhou 350002, China;Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China;Affiliated Rehabilitation Hospital, Fujian University of Chinese Medicine, Fuzhou 350002, China

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

Others  :  1093626
DOI  :  10.1186/1745-6215-14-186

 received in 2012-11-16, accepted in 2013-06-06,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Que et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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