Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
Keywords
Abstract
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.
Dates
| Last Verified: | 09/30/2015 |
| First Submitted: | 06/07/2014 |
| Estimated Enrollment Submitted: | 07/21/2014 |
| First Posted: | 07/22/2014 |
| Last Update Submitted: | 10/19/2015 |
| Last Update Posted: | 10/21/2015 |
| Actual Study Start Date: | 03/31/2013 |
| Estimated Primary Completion Date: | 06/30/2015 |
| Estimated Study Completion Date: | 06/30/2015 |
Condition or disease
Intervention/treatment
Procedure: acupuncture(44mm in length and 32-gauge)
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Acupuncture The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs. | |
| Sham Comparator: sham acupuncture The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen. |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Change from baseline in Barthel index at 8 weeks [Baseline and 8 weeks]
2. Change from baseline in Barthel Index at 16 weeks [Baseline, 16 weeks]
3. Change from baseline in Barthel Index at 24 weeks [Baseline, 24 weeks]
4. Change from baseline in National Institute of Health Stroke Scale at 8 weeks [Baseline, 8 weeks]
5. Change from baseline in National Institute of Health Stroke Scale at 16 weeks [Baseline, 16 weeks]
6. Change from baseline in National Institute of Health Stroke Scale at 24 weeks [Baseline, 24 weeks]
7. Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks [Baseline, 8 weeks]
8. Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks [Baseline, 16 weeks]
9. Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks [Baseline, 24 weeks]
10. Change from baseline in Hamilton Depression Rating Scale at 8 weeks [Baseline, 8 weeks]
11. Change from baseline in Hamilton Depression Rating Scale at 16 weeks [Baseline,16 weeks]
12. Change from baseline in Hamilton Depression Rating Scale at 24 weeks [Baseline, 24 weeks]
Secondary Outcome Measures
1. Change from baseline in Visual Analogue Scale at 8 weeks [Baseline, 8 weeks]
2. Change from baseline in Visual Analogue Scale at 16 weeks [Baseline,16 weeks]
3. Change from baseline in Visual Analogue Scale at 24 weeks [Baseline, 24 weeks]
