Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trialReport as inadecuate




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Trials

, 15:214

First Online: 08 June 2014Received: 03 October 2013Accepted: 19 May 2014DOI: 10.1186-1745-6215-15-214

Cite this article as: Chen, L., Fang, J., Ma, R. et al. Trials 2014 15: 214. doi:10.1186-1745-6215-15-214

Abstract

BackgroundAcupuncture 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-DesignIn 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.

DiscussionThis 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 registrationChinese Clinical Trial RegistryChiCTR-TRC-12001971.

KeywordsAcupuncture Stroke Multicenter RCT AbbreviationsFMAFugl-Meyer Assessment

MCIMild Cognitive Impairment

MMSEMini-Mental State Examination

MoCAMontreal Cognitive Assessment

NIHSSNational Institutes of Health Stroke Scale

VFSSVideo-fluoroscopic Swallowing Study

SPSSStatistical Product and Service Solutions

mRSmodified Rankin Scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-214 contains supplementary material, which is available to authorized users.

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Author: Lifang Chen - Jianqiao Fang - Ruijie Ma - Ronen Froym - Xudong Gu - Jianhua Li - Lina Chen - Shouyu Xu - Conghua Ji

Source: https://link.springer.com/







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