The Efficacy of Acupuncture in Stroke Recovery

ISRCTN	ISRCTN29932220
DOI	https://doi.org/10.1186/ISRCTN29932220
Protocol serial number	D08050703550902
Sponsor	Beijing Municipal Science and Technology Commission (China)
Funders	Beijing Municipal Science and Technology Commission (China), Beijing Hospital of Traditional Chinese Medicine (China)

Submission date: 11/04/2010
Registration date: 29/04/2010
Last edited: 29/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lingpeng Wang
Scientific

Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhoujie
Dongcheng Dis.
Beijing
100010
China

Phone	+86 (0)10 5217 6636
Email	wlp5558@sina.com

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of acupuncture versus standard Western therapy in reducing the rate of deformity of stroke and in improving the quality of life in adult patients: a multicentre randomised controlled trial
Study acronym	EASR
Study objectives	Under the guidance of the theory of Chinese medicine, acupuncture is widely used in treating the stroke in China for a long time. This study is to evaluate the effect of acupuncture in reducing the rate of deformity of stroke and in improving the quality of life.
Ethics approval(s)	Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine approved on the 22nd January 2010 (ref: 201002-1)
Health condition(s) or problem(s) studied	Stroke
Intervention	A total of 328 patients on the acute stage of cerebral apoplexy will be recruited. The patients were randomly divided into two different groups: the intervention group received the treatment of acupuncture and the Western Medicine standard treatment for 3 months and the secondary prevention treatment for 6 months, and the control group received the standard therapy of the Western medicine for 3 months and the secondary prevention treatment for 6 months. Both groups were evaluated with the treatment course of 4 weeks, 12 weeks and 24 weeks. Group A (intervention group): Patients are stimulated by 7 main acupoints: Baihui (Du-20), Quchi (LI-11), Shousanli (LI-10), Hegu (LI-4), Zusanli (ST-36), Yanglingquan (GB-34), Sanyinjiao (SP-6). Acupoints association is used under the guidance of the theory of Chinese medicine and according to the patients' different symptoms, the acupoints below are commonly used: Jianyu (LI-15), Huantiao (GB-10), Qiuxu (GB40), twelve well-jing points, Jinjin (EX-HN 12), Yuye (EX-HN 13), Yamen (DU-15), Lianquan (RN 23), Tianshu (ST-25), Fenglong (ST-40), limb spasm assists with fire needles. The acupoints are stimulated by the filiform needles and the needles are remained for 30 minutes. Patients on the acute stage are treated with the acupoints of Baihui (Du-20), Jinjin (EX-HN 12), Yuye (EX-HN 13), Sishencong (EX-HN 1) and the twelve well-jing points, that use quick insertion of the tri-ensiform needles for bleeding. The needles are remained for 30 minutes every other day, three times a week. As well as the western medicine standard therapy for 3 months and the secondary prevention treatment (the blood pressure control, platelet aggregation, glucose control, etc) for 6 months. Group B: Received the treatment of the standard therapy - the intracranial pressure (ICP) control, the blood pressure control, platelet aggregation, routine physiotherapy and occupational therapy, the secondary prevention treatment as well. Joint Sponsor: Beijing Hospital of Traditional Chinese Medicine (China) No. 23 Meishuguanhoujie Dongcheng District Beijing 100010 China T: +86 (0)10 5217 6852 F: +86 (0)10 5217 6808 Email: postmaster@bjzhongyi.com Website: http://www.bjzhongyi.com
Intervention type	Other
Primary outcome measure(s)	1. Barthel Index (BI) 2. Stroke-Specific Quality Of Life (SS-QOL) Assessments will be conducted at the baseline and at week 4, 12 and 24 follow-up.
Key secondary outcome measure(s)	1. The National Institutes of Health Stroke Scale (NIHSS) 2. Modified Rankin Scale (mRS) Assessments will be conducted at the baseline and at week 4, 12 and 24 follow-up.
Completion date	30/06/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	328
Key inclusion criteria	1. Stroke Patients were diagnosed according to criteria of cerebral arterial thrombosis in Western medicine and the criteria of apoplexy in Chinese medicine 2. The stroke patients were hospitalised because of the acute cerebral arterial thrombosis, that occurred in 10 days 3. Male or female, aged 40 - 75 years 4. National Institutes of Health Stroke Scale (NIHSS) grade from 4 to 21 5. Glasgox Coma Score greater than or equal to 7 6. Patients on the first attack or with a cerebral stroke history but with on serious deformity, modified Rankin Scale (mRS) grade less than or equal to 1 7. Patients who took part in the trail voluntarily and signed the informed consent form
Key exclusion criteria	1. Patients under the treatment of thrombolysis 2. Patients under other clinical trials, or having undergone other clinical trials in the last 3 months 3. Patients with severe primary diseases in cardiovascular system, liver, kidney, hematopoietic system, and psychopathy 4. Pregnant women or women in breast feeding period 5. Inborn handicaps
Date of first enrolment	01/09/2009
Date of final enrolment	30/06/2012

Locations

Countries of recruitment

China

Study participating centre

Beijing Hospital of Traditional Chinese Medicine

Beijing
100010
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	12/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes