Acupuncture for Migraine Prophylaxis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment

Conditions
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Migraine Without Aura, Unilateral Headache

Intervention / Treatment
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* Other: acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupoint-meridian group<br>Apply traditional acupuncture to prevent the migraine attack according to TCM theory | Other: acupuncture<br>* apply acupuncture to prevent the migraine attack<br>|
| Other: sham-acupoint group<br>sham-acupoint will be penetrated for migraine prophylaxis. | Other: acupuncture<br>* apply acupuncture to prevent the migraine attack<br>|
| No Intervention: waiting list<br>No acupuncture nor other methods will be conducted in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of migraine attacks | to assess the frequency of migraine attacks at the 16th week after inclusion | 16th week after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of migraine attacks | to assess the frequency of migraine attacks at the 4th and 24th week respectively | 4th and 24th week after inclusion | 
| headache severity | to evaluate the change of severity of headache | 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, migraine prophylaxis