Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

Stroke Clinical Trial

Official title:

Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02197663
• Other study ID #: CMUH102-REC2-015
• Status: Terminated
• Phase: Phase 1
• First received: June 8, 2014
• Last updated: October 20, 2015
• Start date: April 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The lifestyle of Taiwanese people has been changed over the past decade with the improvement of economic growth, environmental sanitation and the quality of medical care. Now the investigators pay more attention to the increasing risk of people's diseases of civilization than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the patient of cerebrovascular accident cause a lot of money and is a burden of our country.

Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with cerebrovascular accident. The investigators use some scales to assess efficacy of acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.

Besides, the investigators notice that there are few journals about acupuncture effect of treating depression following cerebral vascular accident. The investigators may underestimate the amount of people having post-stroke depression. So the investigators use Hamilton Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident patient.

By assessing bio-psycho-social level of CVA patient, the investigators hope this study will offer them more "Holistic Health Care".

Description:

We want to assess the effect of acupuncture on stroke patients. The study is a double-blind randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:

(1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia

Exclusion Criteria:

(1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.

The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.

The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last time of treatment). The course of treatment should be completed within 3 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia

Exclusion Criteria:

• transient ischemic attack

• brain tumor, brain trauma

• recurrent stroke

• multiple organs failure, cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• acupuncture(44mm in length and 32-gauge)
The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.

Locations

Country	Name	City	State
Taiwan	Department of Acupuncture, China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Barthel index at 8 weeks		Baseline and 8 weeks	No
Primary	Change from baseline in Barthel Index at 16 weeks		Baseline, 16 weeks	No
Primary	Change from baseline in Barthel Index at 24 weeks		Baseline, 24 weeks	No
Primary	Change from baseline in National Institute of Health Stroke Scale at 8 weeks		Baseline, 8 weeks	No
Primary	Change from baseline in National Institute of Health Stroke Scale at 16 weeks		Baseline, 16 weeks	No
Primary	Change from baseline in National Institute of Health Stroke Scale at 24 weeks		Baseline, 24 weeks	No
Primary	Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks		Baseline, 8 weeks	No
Primary	Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks		Baseline, 16 weeks	No
Primary	Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks		Baseline, 24 weeks	No
Primary	Change from baseline in Hamilton Depression Rating Scale at 8 weeks		Baseline, 8 weeks	No
Primary	Change from baseline in Hamilton Depression Rating Scale at 16 weeks		Baseline,16 weeks	No
Primary	Change from baseline in Hamilton Depression Rating Scale at 24 weeks		Baseline, 24 weeks	No
Secondary	Change from baseline in Visual Analogue Scale at 8 weeks		Baseline, 8 weeks	No
Secondary	Change from baseline in Visual Analogue Scale at 16 weeks		Baseline,16 weeks	No
Secondary	Change from baseline in Visual Analogue Scale at 24 weeks		Baseline, 24 weeks	No