Migraine Without Aura, Unilateral Headache
Conditions
Keywords
acupuncture, migraine prophylaxis
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.
Interventions
OTHERacupuncture
apply acupuncture to prevent the migraine attack
Sponsors
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Li ying
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frequency of migraine attacks | 16th week after inclusion | to assess the frequency of migraine attacks at the 16th week after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| frequency of migraine attacks | 4th and 24th week after inclusion | to assess the frequency of migraine attacks at the 4th and 24th week respectively |
| headache severity | 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion | to evaluate the change of severity of headache |
Other
| Measure | Time frame | Description |
|---|---|---|
| MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1) | the day of inclusion and 4th week after inclusion | to observe the change of MSQ |
| acupuncture expectation scale | 1 day | an outcome to indicate the expectation of patient towards acupuncture treatment for migraine |
Countries
China
Outcome results
None listed