Contact information
Type
Scientific
Primary contact
Prof Lingpeng Wang
ORCID ID
Contact details
Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhoujie
Dongcheng Dis.
Beijing
100010
China
+86 (0)10 5217 6636
wlp5558@sina.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D08050703550902
Study information
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
Acronym
EASR
Study hypothesis
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
Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine approved on the 22nd January 2010 (ref: 201002-1)
Study design
Multicentre randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact shizheng83@hotmail.com to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2009
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
328
Participant 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
Recruitment start date
01/09/2009
Recruitment end date
30/06/2012
Locations
Countries of recruitment
China
Trial participating centre
Beijing Hospital of Traditional Chinese Medicine
Beijing
100010
China
Sponsor information
Organisation
Beijing Municipal Science and Technology Commission (China)
Sponsor details
No. 16 Xizhimendajie
Xicheng Dis.
Beijing
100035
China
+86 (0)10 6615 3395
bjkwwz@sina.com
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Beijing Municipal Science and Technology Commission (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Beijing Hospital of Traditional Chinese Medicine (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23145765
Publication citations
-
Protocol
Liu H, Zhang D, Tan X, Yang D, Wang G, Zhao Y, Wen Y, Shi G, Wang L, The effect of acupuncture on stroke recovery: study protocol for a randomized controlled trial., BMC Complement Altern Med, 2012, 12, 216, doi: 10.1186/1472-6882-12-216.