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Randomized Controlled Trial of Treating Migraine With Acupuncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00599586
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
Chengdu University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE January 3, 2008
First Posted Date  ICMJE January 24, 2008
Last Update Posted Date June 29, 2010
Study Start Date  ICMJE November 2007
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2008)
  • number of days with migraine [ Time Frame: 4 weeks ]
  • frequency of migraine attacks [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
VAS score [ Time Frame: a month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2008)
  • Migraine-Specific Quality-of-Life Questionnaire [ Time Frame: a month ]
  • Transcranial Doppler Sonography [ Time Frame: a month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Treating Migraine With Acupuncture
Official Title  ICMJE Randomized Controlled Trial of Treating Migraine With Acupuncture
Brief Summary 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."
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."
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Other Name: electro-acupuncture
Study Arms  ICMJE
  • Experimental: group 1
    specific acupoints of Shaoyang meridians
    Intervention: Other: acupuncture
  • Experimental: Group 2
    Non-specific acupoints of Shaoyang meridians
    Intervention: Other: acupuncture
  • Experimental: group 3
    Acupoints of other meridians
    Intervention: Other: acupuncture
  • Sham Comparator: group 4
    Non-acupoints
    Intervention: Other: acupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2008)
480
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2008)
360
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599586
Other Study ID Numbers  ICMJE 2006CB5045011
2006CB5045011 ( Other Grant/Funding Number: 973 program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liang Fanrong, Acupuncture & Tuina college of chengdu univeristy of TCM
Study Sponsor  ICMJE Chengdu University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Fan-rong Liang, master Chengdu University of TCM
PRS Account Chengdu University of Traditional Chinese Medicine
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP