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Acupuncture for Migraine Prophylaxis (AMP)

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ClinicalTrials.gov Identifier: NCT01687660
Recruitment Status : Unknown
Verified May 2013 by 973-2, Chengdu University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : September 19, 2012
Last Update Posted : October 23, 2013
Sponsor:
Collaborators:
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Information provided by (Responsible Party):
973-2, Chengdu University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date October 23, 2013
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
frequency of migraine attacks [ Time Frame: 16th week after inclusion ]
to assess the frequency of migraine attacks at the 16th week after inclusion
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01687660 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • frequency of migraine attacks [ Time Frame: 4th and 24th week after inclusion ]
    to assess the frequency of migraine attacks at the 4th and 24th week respectively
  • headache severity [ Time Frame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion ]
    to evaluate the change of severity of headache
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2012)
  • MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1) [ Time Frame: the day of inclusion and 4th week after inclusion ]
    to observe the change of MSQ
  • acupuncture expectation scale [ Time Frame: 1 day ]
    an outcome to indicate the expectation of patient towards acupuncture treatment for migraine
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Migraine Prophylaxis
Official Title  ICMJE A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
Brief Summary Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian, non-acupoint-meridian group, and waiting list.
Detailed Description Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Migraine Without Aura
  • Unilateral Headache
Intervention  ICMJE Other: acupuncture
apply acupuncture to prevent the migraine attack
Study Arms  ICMJE
  • Experimental: acupoint-meridian group
    Apply traditional acupuncture to prevent the migraine attack according to TCM theory
    Intervention: Other: acupuncture
  • sham-acupoint group
    sham-acupoint will be penetrated for migraine prophylaxis.
    Intervention: Other: acupuncture
  • No Intervention: waiting list
    No acupuncture nor other methods will be conducted in this group.
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2013)
249
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
243
Estimated Study Completion Date  ICMJE September 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age of a subject is between 18 and 65 years old(initially occured beneath the age of 50), male or female;
  • in accordance with diagnosis of migraine without aura in International Classification of Headache Disorders, ICHD-2, by IHS;
  • 2 to 8 times attack per month in recent 3 months, with each period beyond 15 days;
  • with migraine history for over 1 year;
  • be able and willing to finish the headache diary in baseline ;
  • informed consent form must be signed by patient or lineal relative;

Exclusion Criteria:

  • Patients who are unconscious, psychotic.
  • Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
  • With serious primary illness or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
  • 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 Yes
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 NCT01687660
Other Study ID Numbers  ICMJE 2012CB518501-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 973-2, Chengdu University of Traditional Chinese Medicine
Study Sponsor  ICMJE 973-2
Collaborators  ICMJE
  • Hunan University of Traditional Chinese Medicine
  • Chongqing Medical University
Investigators  ICMJE
Principal Investigator: Fanrong Liang, Professor Chengdu University of Traditional Chinese Medicine
PRS Account Chengdu University of Traditional Chinese Medicine
Verification Date May 2013

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