The Efficacy of Acupuncture in Stroke Recovery
| ISRCTN | ISRCTN29932220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29932220 |
| Secondary identifying numbers | D08050703550902 |
- 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
Scientific
Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhoujie
Dongcheng Dis.
Beijing
100010
China
| Phone | +86 (0)10 5217 6636 |
|---|---|
| wlp5558@sina.com |
Study information
| Study design | Multicentre randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact shizheng83@hotmail.com to request a patient 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/09/2009 |
| Completion date | 30/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
100010
China
Sponsor information
Beijing Municipal Science and Technology Commission (China)
Government
Government
No. 16 Xizhimendajie
Xicheng Dis.
Beijing
100035
China
| Phone | +86 (0)10 6615 3395 |
|---|---|
| bjkwwz@sina.com | |
| Website | http://www.bjkw.gov.cn/n1143/index.html |
"ROR" |
https://ror.org/034k14f91 |
Funders
Funder type
Government
Beijing Municipal Science and Technology Commission (China)
No information available
Beijing Hospital of Traditional Chinese Medicine (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
