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Randomized Controlled Trial
. 2014 Jun 8:15:214.
doi: 10.1186/1745-6215-15-214.

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

Lifang Chen, Jianqiao Fang  1 , Ruijie Ma, Ronen Froym, Xudong Gu, Jianhua Li, Lina Chen, Shouyu Xu, Conghua Ji
Affiliations
Randomized Controlled Trial

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

Lifang Chen et al. Trials. .

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.

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Figures

Figure 1
Figure 1
Flow diagram of study design.
See this image and copyright information in PMC

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