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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: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 243 participants will be included. Three arms: acupuncture in acupoint-meridian， non-acupoint-meridian group, and waiting list.


Condition Intervention Phase
Migraine Without Aura
Unilateral Headache
 Other: acupuncture
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 243
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupoint-meridian group
Apply traditional acupuncture to prevent the migraine attack according to TCM theory
 Other: acupuncture
apply acupuncture to prevent the migraine attack
sham-acupoint group
sham-acupoint will be penetrated for migraine prophylaxis.
 Other: acupuncture
apply acupuncture to prevent the migraine attack
No Intervention: waiting list
No acupuncture nor other methods will be conducted in this group.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687660

Contacts
Contact: Li Ying, professor 13708095607

Locations
China, Sichuan
Chengdu University of TCM Recruiting
Chengdu, Sichuan, China, 610075
Contact: Liang Fan-rong, MD     86-13438151411     acuresearch@126.com    
Sponsors and Collaborators
973-2
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Investigators
Study Chair: Liang Fan Rong, MD Chengdu University of Traditional Chinese Medicine
  More Information

No publications provided

Responsible Party: 973-2, Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01687660     History of Changes
Other Study ID Numbers: 2012CB518501-2
Study First Received: August 31, 2012
Last Updated: May 10, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chengdu University of Traditional Chinese Medicine:
acupuncture
migraine prophylaxis

Additional relevant MeSH terms:
Headache
Migraine Disorders
Migraine without Aura
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013