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Randomized Controlled Trial of Treating Migraine With Acupuncture

This study has been completed.
Sponsor:
Information provided by:
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00599586
First received: January 3, 2008
Last updated: June 27, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of the study is to testify whether acupuncture is effective for migraine, and provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."


Condition Intervention
Migraine
 Other: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Treating Migraine With Acupuncture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • number of days with migraine [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • frequency of migraine attacks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Migraine-Specific Quality-of-Life Questionnaire [ Time Frame: a month ] [ Designated as safety issue: Yes ]
  • Transcranial Doppler Sonography [ Time Frame: a month ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 1
specific acupoints of Shaoyang meridians
 Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Other Name: electro-acupuncture
Experimental: Group 2
Non-specific acupoints of Shaoyang meridians
 Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Other Name: electro-acupuncture
Experimental: group 3
Acupoints of other meridians
 Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Other Name: electro-acupuncture
Sham Comparator: group 4
Non-acupoints
 Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Other Name: electro-acupuncture

Detailed Description:

The purpose of the study is to testify whether acupuncture is effective for migraine, through treating migraine patients for a month, using different acupoints according to literatures of treating migraine with acupuncture, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of a subject is older than 18 and is younger than 65.(The subject is younger than 50 when he was ill for the first time.)
  2. Consistent with the diagnostic criteria of Premonitory Migraine and Non- Premonitory Migraine.
  3. Attacks of migraine are equal to or more than 2 times in the last three months.
  4. With more than one year history of migraine
  5. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

  1. With serious protopathy or disease of cardiovascular, liver, renal,gastrointestinal, hematological systems and so on.
  2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.
  3. Patients have used drugs for preventing migraine in the last four weeks.
  4. Pregnant women or women in lactation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599586

Locations
China, Sichuan
Chengdu University of TCM
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Chair: Fan-rong Liang, master Chengdu University of TCM
  More Information

Additional Information:
funded by 973 programme of china  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Liang Fanrong, Acupuncture & Tuina college of chengdu univeristy of TCM
ClinicalTrials.gov Identifier: NCT00599586     History of Changes
Other Study ID Numbers: 2006CB5045011, 2006CB5045011
Study First Received: January 3, 2008
Last Updated: June 27, 2010
Health Authority: China: Ethics Committee

Keywords provided by Chengdu University of Traditional Chinese Medicine:
migraine
acupuncture
efficacy
 safety
meridian
acupoint

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013