Acupuncture for Migraine Prophylaxis (AMP)

This study is currently recruiting participants.
Verified May 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Information provided by (Responsible Party):
973-2, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01687660
First received: August 31, 2012
Last updated: October 22, 2013
Last verified: May 2013

August 31, 2012
October 22, 2013
September 2012
September 2014   (final data collection date for primary outcome measure)
frequency of migraine attacks [ Time Frame: 16th week after inclusion ] [ Designated as safety issue: Yes ]
to assess the frequency of migraine attacks at the 16th week after inclusion
Same as current
Complete list of historical versions of study NCT01687660 on ClinicalTrials.gov Archive Site
  • frequency of migraine attacks [ Time Frame: 4th and 24th week after inclusion ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    to evaluate the change of severity of headache
Same as current
  • MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1) [ Time Frame: the day of inclusion and 4th week after inclusion ] [ Designated as safety issue: Yes ]
    to observe the change of MSQ
  • acupuncture expectation scale [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    an outcome to indicate the expectation of patient towards acupuncture treatment for migraine
Same as current
 
Acupuncture for Migraine Prophylaxis
A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Migraine Without Aura
  • Unilateral Headache
Other: acupuncture
apply acupuncture to prevent the migraine attack
  • 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.
Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
249
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Li Ying, professor 13708095607
China
 
NCT01687660
2012CB518501-2
Yes
973-2, Chengdu University of Traditional Chinese Medicine
973-2
  • Hunan University of Traditional Chinese Medicine
  • Chongqing Medical University
Principal Investigator: Fanrong Liang, Professor Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
May 2013

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