Acupuncture for Migraine Prophylaxis (AMP)

Li ying

Status: Completed

Conditions: Migraine Without Aura; Unilateral Headache

Treatments: Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01687660

2012CB518501-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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249 participants in 3 patient groups

acupoint-meridian group

Experimental group

Description:

Apply traditional acupuncture to prevent the migraine attack according to TCM theory

Treatment:

Other: acupuncture

sham-acupoint group

Other group

Description:

sham-acupoint will be penetrated for migraine prophylaxis.

Treatment:

Other: acupuncture

waiting list

No Intervention group

Description:

No acupuncture nor other methods will be conducted in this group.