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| [ ...Back to search results ] | [ Print-friendly version ] |
| The Efficacy of Acupuncture in Spasm after Stroke |
| ISRCTN | ISRCTN84985339 |
| ClinicalTrials.gov identifier | |
| Public title | The Efficacy of Acupuncture in Spasm after Stroke |
| Scientific title | Comparison of the effect of acupuncture versus sham acupuncture in reducing the incidence rate of spasm and alleviate the severity of spasm in adult patients: a multicentre randomised controlled trial |
| Acronym | EASS |
| Serial number at source | D08050703550902 |
| Study hypothesis | Spasm is a common neopathy after stroke. Spasticity may influence the recovery of motor function which reduces the patients' quality of life. Experts are now arguing on the efficacy of acuncture in spasm after stroke. Our study is to verify whether stimulating Jiajixue before the spasm occurrs in the acute stage may reduce the incidence rate of spasm and alleviate the severity of spasm. |
| Lay summary | |
| 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 single blind placebo controlled study |
| Countries of recruitment | China |
| Disease/condition/study domain | Stroke |
| Participants - 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. Stroke occurred within 14 days 3. Male or female, aged 40-75 4. National Institute of Health Stroke Scale (NIHSS) grade from 4 to 21 5. The muscle strength of the affected limbs is less than grade 3 6. No disorder of consciousness according to Glasgow Coma Scale (GCS) 7. Patients suffering their first attack or with a cerebral stroke history but with on serious deformity, modified Rankin SCale (mRS) grade >1 8. Diagnosed by the computed tomography (CT) or magnetic resonance imaging (MRI) 9. Patients who took part in the trial voluntarily and signed the informed consent form |
| Participants - exclusion criteria |
1. Patients receiving treatment for thrombolysis
2. Patients also have other neurological diseases or other illness which may cause abnormal muscle tension 3. Patients involved in other clinical trials, or having undergone other clinical trials in the last 3 months 4. Patients with severe primary diseases of the cardiovascular system, liver, kidney, hematopoietic system, or psychopathy 5. Pregnant women or women who are breast-feeding 6. Congenital disabilities |
| Anticipated start date | 01/08/2009 |
| Anticipated end date | 30/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact shizheng83@hotmail.com to request a patient information sheet |
| Target number of participants | 254 |
| Interventions |
A total of 254 patients in the acute stage of Cerebral apoplexy will be recruited. One half of the patients are from the Acupuncture Department of Beijing Huguosi Chinese Medicine Hospital while the other half are from the Acupuncture Department of Beijing Hospital of Traditional Chinese Medicine. The patients were randomly divided into two different groups. The treatment group receive the Wang Jiajixue remedy, the standard therapy of acupuncture and the basic treatment of western medicine for 4 weeks, the control group receive the sham acupuncture and the standard therapy of the acupuncture and the basic treatment of western medicine for 4 weeks. Both groups were evaluated at the baseline, 2 weeks, 4 weeks and 12 weeks.
1. The treatment group 1.1. Wang Jiajixue are selected from Jiaji (EX-B2). Location: 0.3 cun lateral to the lower border of the 2nd, 4th, 6th, 8th, 10th, 12th thoracic vertibra, and the 2nd, 4th lumber vertibra. 8 points on each side. Methods: lateral lying position, affected limb upwards. Use the uniform reinforcing-reducing method with stainless steel needles of 0.32 mm diameter, 40mm length, perpendicular insertion, the filiform needles are left for 30 minutes after the needling sensation, five days a week. The depth of the insertion is 25mm. 1.2. Standard acupuncture treatment: Quchi (LI-11), Waiguan, Hegu (LI-4), Zusanli (ST-36), Yanglingquan (GB-34), Sanyinjiao (SP-6) on the affected limb. Use the uniform reinforcing-reducing method with stainless steel needles of 0.32 mm diameter, 40mm length, perpendicular insertion, the filiform needles are left for 30 minutes after the needling sensation, five days a week. The depth of the insertion is 25mm. 1.3. Received standard care; ICP (Intracranial Pressure) control, blood pressure control, platelet aggregation, trophic nerve, routine physiotherapy and occupational therapy for 4 weeks. 2. The control group: the sham acupuncture 2.1. Location: 0.1 cun lateral to the lower border of the 2nd, 4th, 6th, 8th, 10th, 12th thoracic vertibra, and the 2nd, 4th lumber vertibra. 8 points on each side. Methods: lateral lying position, affected limb upwards. Use the needle of stainless steel needles of 0.32 mm diameter, 40mm length, perpendicular insertion, the filiform needles are left for 30 minutes, no needling sensation, five days a week. The depth of the insertion is 5mm. Standard acupuncture treatment: Quchi (LI-11), Waiguan, Hegu (LI-4), Zusanli (ST-36), Yanglingquan (GB-34), Sanyinjiao (SP-6) on the affected limb. Use the uniform reinforcing-reducing method with the needle of stainless steel needles of 0.32 mm diameter, 40mm length, perpendicular insertion, the filiform needles are left for 30 minutes after the needling sensation, five days a week. The depth of the needles is 25mm. 2.2. As well as the western medicine standard care for 4 weeks. 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 |
| Primary outcome measure(s) |
1. Modified Ashworth Scale for Spasticity (MASS)
2. Fugl-Meyer (FMA) 3. Motor assessment scale (MAS) Assessments will be conducted at baseline and at week 2, 4 and 12 follow-up. |
| Secondary outcome measure(s) |
1. Activities of daily living (ADL)
2. The NIH Stroke Scale (NIHSS) 3. Stroke Speciality-Quality of Life (SS-QOL) 4. Modified Rankin Scale (mRS) Assessments will be conducted at baseline and at week 2, 4 and 12 follow-up, it is likely to adopt the follow up face to face. |
| Sources of funding |
1. Beijing Municipal Science and Technology Commission (China)
2. Beijing Hospital of Traditional Chinese Medicine (China) |
| Trial website | |
| Publications | |
| Contact name | Prof Linpeng Wang |
| Address |
Beijing Hospital of Traditional Chinese Medicine
No.23 Meishuguanhoujie Dongcheng Dis. |
| City/town | Beijing |
| Zip/Postcode | 100010 |
| Country | China |
| Tel | +86 (0)10 5217 6636 |
| Fax | +86 (0)10 5217 6808 |
| wlp5558@sina.com | |
| Sponsor | Beijing Municipal Science and Technology Commission (China) |
| Address |
No. 16 Xizhimendajie
Xicheng Dis. |
| City/town | Beijing |
| Zip/Postcode | 100035 |
| Country | China |
| Tel | +86 (0)10 6615 3395 |
| bjkwwz@sina.com | |
| Sponsor website: | http://www.bjkw.gov.cn/n1143/index.html |
| Date applied | 24/09/2010 |
| Last edited | 19/10/2010 |
| Date ISRCTN assigned | 19/10/2010 |
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