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

被引:15
作者
Chen, Lifang [1 ]
Fang, Jianqiao [1 ,2 ]
Ma, Ruijie [1 ]
Froym, Ronen [2 ]
Gu, Xudong [3 ]
Li, Jianhua [4 ]
Chen, Lina [5 ]
Xu, Shouyu [6 ]
Ji, Conghua [7 ]
机构
[1] Zhejiang Chinese Med Univ, Affiliated Hosp 3, Dept Acupuncture, Hangzhou 310005, Zhejiang, Peoples R China
[2] Zhejiang Chinese Med Univ, Clin Med Coll 3, Hangzhou 310053, Zhejiang, Peoples R China
[3] Second Hosp Jiaxing, Dept Rehabil, Jiaxing 314000, Zhejiang, Peoples R China
[4] Zhejiang Univ, Sch Med, Sir Run Run Shaw Hosp, Dept Rehabil, Hangzhou 310016, Zhejiang, Peoples R China
[5] First Peoples Hosp Hangzhou, Dept Rehabil, Hangzhou 310006, Zhejiang, Peoples R China
[6] Zhejiang Chinese Med Univ, Affiliated Hosp 3, Dept Rehabil, Hangzhou 310005, Zhejiang, Peoples R China
[7] Zhejiang Prov Hosp TCM, Clin Res Inst, Hangzhou 310006, Zhejiang, Peoples R China
来源
TRIALS | 2014年 / 15卷
关键词
Acupuncture; Stroke; Multicenter RCT; MINI-MENTAL-STATE; ISCHEMIC-STROKE; BURDEN; CHINA;
D O I
10.1186/1745-6215-15-214
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
引用
收藏
页数:6
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