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Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

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ClinicalTrials.gov Identifier: NCT02197663
Recruitment Status : Terminated (the numbers of drop-out patients are more than we anticipate)
First Posted : July 23, 2014
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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".


Condition or disease Intervention/treatment Phase
Stroke Procedure: acupuncture(44mm in length and 32-gauge) Phase 1

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident
Study Start Date : April 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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)




Primary Outcome Measures :
  1. Change from baseline in Barthel index at 8 weeks [ Time Frame: Baseline and 8 weeks ]
  2. Change from baseline in Barthel Index at 16 weeks [ Time Frame: Baseline, 16 weeks ]
  3. Change from baseline in Barthel Index at 24 weeks [ Time Frame: Baseline, 24 weeks ]
  4. Change from baseline in National Institute of Health Stroke Scale at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  5. Change from baseline in National Institute of Health Stroke Scale at 16 weeks [ Time Frame: Baseline, 16 weeks ]
  6. Change from baseline in National Institute of Health Stroke Scale at 24 weeks [ Time Frame: Baseline, 24 weeks ]
  7. Change from baseline in Instrumental Activities of Daily Living Scale at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  8. Change from baseline in Instrumental Activities of Daily Living Scale at 16 weeks [ Time Frame: Baseline, 16 weeks ]
  9. Change from baseline in Instrumental Activities of Daily Living Scale at 24 weeks [ Time Frame: Baseline, 24 weeks ]
  10. Change from baseline in Hamilton Depression Rating Scale at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  11. Change from baseline in Hamilton Depression Rating Scale at 16 weeks [ Time Frame: Baseline,16 weeks ]
  12. Change from baseline in Hamilton Depression Rating Scale at 24 weeks [ Time Frame: Baseline, 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Visual Analogue Scale at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  2. Change from baseline in Visual Analogue Scale at 16 weeks [ Time Frame: Baseline,16 weeks ]
  3. Change from baseline in Visual Analogue Scale at 24 weeks [ Time Frame: Baseline, 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197663


Locations
Taiwan
Department of Acupuncture, China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
Investigators
Study Director: Yu-Chen Lee, PHD Department of Acupuncture, China Medical University Hospital

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02197663     History of Changes
Other Study ID Numbers: CMUH102-REC2-015
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by China Medical University Hospital:
acupuncture
stroke
Randomized Controlled Trial

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases