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Open Access Highly Accessed Study protocol

Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial

Lifang Chen1, Jianqiao Fang12*, Ruijie Ma1, Ronen Froym2, Xudong Gu3, Jianhua Li4, Lina Chen5, Shouyu Xu6 and Conghua Ji7

Author Affiliations

1 Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical University, No. 219 Moganshan Road, XiHu District, Hangzhou, Zhejiang Province 310005, China

2 The Third Clinical Medical College of Zhejiang Chinese Medical University, No. 548 Binwen Road, Binjiang District, Hangzhou, Zhejiang Province 310053, China

3 Department of Rehabilitation, The Second Hospital of Jiaxing, No. 1518 North HuanCheng Road, JiaXing, Zhejiang Province 314000, China

4 Department of Rehabilitation, Sir Run Run Shaw Hospital (ZheJiang University School of Medicine), No. 3 East Qingchun Road, Hangzhou, Zhejiang Province 310016, China

5 Department of Rehabilitation, The First People’s Hospital of Hangzhou, No. 261, HuanSha Road, Hangzhou, Zhejiang Province 310006, China

6 Department of Rehabilitation, The Third Affiliated Hospital of Zhejiang Chinese Medical University, No. 219 Moganshan Road, XiHu District, Hangzhou, Zhejiang Province 310005, China

7 The Clinical Research Institute of Zhejiang Provincial Hospital of TCM, No. 54 Youdian Road, Hangzhou, Zhejiang Province 310006, China

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Trials 2014, 15:214  doi:10.1186/1745-6215-15-214

Published: 8 June 2014

Abstract

Background

Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years. However, previous research has not yet shown that acupuncture is effective as a stroke treatment. We report a protocol for a multicenter, randomized, controlled, and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on acute ischemic stroke.

Methods/Design

In a prospective trial involving three hospitals in the Zhejiang Province (China) 250 patients with a recent (less than 1 week previous) episode of ischemic stroke will be included. Patients will be randomized into two groups: an acupuncture group given scalp acupuncture and electroacupuncture, and a control group given no acupuncture. Eighteen treatment sessions will be performed over a three-week period. The primary outcome will be measured by changes in the National Institutes of Health Stroke Scale score at the one, three, and four-week follow-up. Secondary outcome measures will be: 1) the Fugl-Meyer assessment scale for motor function; 2) the mini-mental state examination and Montreal cognitive assessment for cognitive function; 3) the video-fluoroscopic swallowing study for swallowing ability; and 4) the incidence of adverse events.

Discussion

This trial is expected to clarify whether or not acupuncture is effective for acute stroke. It will also show if acupuncture can improve motor, cognitive, or swallowing function.

Trial registration

Chinese Clinical Trial Registry ChiCTR-TRC-12001971.

Keywords:
Acupuncture; Stroke; Multicenter RCT