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 Registry ChiCTR-TRC-12001971.

Highlights

  • Acupuncture has been widely used as a treatment for stroke in China for more than 3,000 years

  • This trial is expected to clarify whether or not acupuncture is effective for acute stroke

  • Baseline assessments Baseline assessments will be conducted before randomization, including gender and age of patients, clinical syndrome, diseased location and size, National Institutes of Health Stroke Scale (NIHSS) and Fugl-Meyer assessment (FMA) scores, cognitive impairment based on the Montreal cognitive assessment (MoCA), and swallowing disorder according to the standardized swallowing assessment

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Summary

Background

Stroke is a major cause of death and disability worldwide [1,2,3]. It is the leading cause of death and long-term disability in China [4,5], where a rising incidence of stroke has created a serious public health problem [6,7]. There is no doubt that the treatment of stroke should be combined with multiple disciplines such as neurology, rehabilitation medicine, and traditional medicine. Appears to be beneficial for the motor function recovery of patients with acute ischemic stroke and is generally safe [15]. There is insufficient data on the routine usage of acupuncture in acute stroke. Large, multicenter, randomized trials are needed to further assess the effectiveness of acupuncture on stroke rehabilitation

Methods/Design
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