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

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• 作者：Lifang Chen (1)
  Jianqiao Fang (1) (2)
  Ruijie Ma (1)
  Ronen Froym (2)
  Xudong Gu (3)
  Jianhua Li (4)
  Lina Chen (5)
  Shouyu Xu (6)
  Conghua Ji (7)
  
  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鈥檚 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
  
• 关键词：Acupuncture ; Stroke ; Multicenter RCT
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：479 KB
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

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.