Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

NCT ID: NCT02197663

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-07-31

Brief 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".

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture

The total course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.

Group Type: EXPERIMENTAL

acupuncture(44mm in length and 32-gauge)

Intervention Type: PROCEDURE

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.

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.

Group Type: SHAM_COMPARATOR

acupuncture(44mm in length and 32-gauge)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

acupuncture(4.4cm in length and 32-gauge); shame acupuncture(1.27 cm in length and 40-gauge)

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chen Lee, PHD

Role: STUDY_DIRECTOR

Department of Acupuncture, China Medical University Hospital

Locations

Department of Acupuncture, China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH102-REC2-015

Identifier Type: -

Identifier Source: org_study_id