Condition category
Circulatory System
Date applied
24/09/2010
Date assigned
19/10/2010
Last edited
03/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
Spasms are a sudden involuntary contraction of a muscle or a group of muscles. They are a common complication after a stroke. The aim of this study is to test whether acupuncture reduces the rate and severity of spasms after a stroke.

Who can participate?
Patients aged 40-75 who have had a stroke within the last 14 days

What does the study involve?
Participants are randomly allocated into two different groups. The treatment group receive acupuncture treatment and the basic treatment of western medicine for 4 weeks, while the control group receive sham acupuncture and the basic treatment of western medicine for 4 weeks. Both groups are assessed at the start of the study and at 2 weeks, 4 weeks and 12 weeks follow-up.

What are the possible benefits and risks of participating?
The possible benefits of acupuncture include reducing the rate and severity of spasms. Possible risks of acupuncture may include bleeding and bruising.

Where is the study run from?
1. Beijing Traditional Chinese Medical Hospital affiliated with Capital Medical University (China)
2. Beijing Huguosi Chinese Medicine Hospital affiliated with Capital Medical University (China)

When is the study starting and how long is it expected to run for?
August 2009 to December 2013

Who is funding the study?
1. Beijing Municipal Science and Technology Commission (China)
2. Beijing Hospital of Traditional Chinese Medicine (China)

Who is the main contact?
Prof. Lin-Peng Wang
wlp5558@sina.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Linpeng 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

D09050703550902

Study information

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

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 acupuncture in spasm after stroke. Our study is to verify whether stimulating Jiajixue before the spasm occurs in the acute stage may reduce the incidence rate of spasm and alleviate the severity of spasm.

Ethics approval

Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine, 22/01/2010, ref: 201002-1

Study design

Multicentre randomised single-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

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 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/08/2009

Overall trial end date

30/12/2013

Reason abandoned

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. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

254

Participant 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 breastfeeding
6. Congenital disabilities

Recruitment start date

01/08/2009

Recruitment end date

30/12/2013

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

http://www.bjkw.gov.cn/n1143/index.html

Organisation

Beijing Hospital of Traditional Chinese Medicine (China)

Sponsor details

No. 23 Meishuguanhoujie
Dongcheng District
Beijing
100010
China
+86 (0)10 5217 6852
postmaster@bjzhongyi.com

Sponsor type

Hospital/treatment centre

Website

www.bjzhongyi.com

Funders

Funder type

Hospital/treatment centre

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/08/2016: Plain English summary added. 17/12/2012: the overall trial end date was updated from 30/06/2012 to 30/12/2013.