Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial

Because this is being conducted during the first 8 weeks there can be no objective conclusions as to any efficacy of TCM because of the normal spontaneous recovery during that time frame.
http://bmjopen.bmj.com/content/4/12/e007080.full

1. Jianqiao Fang1,2,
2. Lifang Chen1,
3. Luni Chen2,
4. Chao Wang2,
5. Crystal Lynn Keeler3,
6. Ruijie Ma1,
7. Shouyu Xu4,
8. Laihua Shen5,
9. Yehua Bao6,
10. Conghua Ji7

+ Author Affiliations

1. ¹Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, Hangzhou, Zhejiang, China
2. ²The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China
3. ³Department of Innovations to Wellness, Affiliated with Five Branches University, San Jose, California, USA
4. ⁴Department of Rehabilitation, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China
5. ⁵Department of Acupuncture & Encephalopathy, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, Zhejiang, China
6. ⁶Department of Acupuncture & Rehabilitation, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China
7. ⁷The Clinical Research Institute of Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China

1. Correspondence to Professor Jianqiao Fang; fangjianqiao7532@163.com

• Received 4 November 2014
• Revised 11 November 2014
• Accepted 12 November 2014
• Published 4 December 2014

Abstract

Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation.

Methods and analysis 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks’ follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events.

Ethics and dissemination Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status.

Trial registration number Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561