Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

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".

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Procedure: acupuncture(44mm in length and 32-gauge)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Department of Acupuncture, China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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.; Other Names: acupuncture(4.4cm in length and 32-gauge); shame acupuncture(1.27 cm in length and 40-gauge)
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.	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.; Other Names: acupuncture(4.4cm in length and 32-gauge); shame acupuncture(1.27 cm in length and 40-gauge)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Barthel index at 8 weeks	Baseline and 8 weeks
Change from baseline in Barthel Index at 16 weeks	Baseline, 16 weeks
Change from baseline in Barthel Index at 24 weeks	Baseline, 24 weeks
Change from baseline in National Institute of Health Stroke Scale at 8 weeks	Baseline, 8 weeks
Change from baseline in National Institute of Health Stroke Scale at 16 weeks	Baseline, 16 weeks
Change from baseline in National Institute of Health Stroke Scale at 24 weeks	Baseline, 24 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks	Baseline, 8 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks	Baseline, 16 weeks
Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks	Baseline, 24 weeks
Change from baseline in Hamilton Depression Rating Scale at 8 weeks	Baseline, 8 weeks
Change from baseline in Hamilton Depression Rating Scale at 16 weeks	Baseline,16 weeks
Change from baseline in Hamilton Depression Rating Scale at 24 weeks	Baseline, 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Visual Analogue Scale at 8 weeks	Baseline, 8 weeks
Change from baseline in Visual Analogue Scale at 16 weeks	Baseline,16 weeks
Change from baseline in Visual Analogue Scale at 24 weeks	Baseline, 24 weeks

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Director: Yu-Chen Lee, PHD, Department of Acupuncture, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 8, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 22, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: stroke; acupuncture; Randomized Controlled Trial
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CMUH102-REC2-015