Acupuncture for Migraine Prophylaxis

Li ying249 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

249

Conditions

Migraine Without Aura Unilateral Headache

Interventions

acupunctureOTHER

apply acupuncture to prevent the migraine attack

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Chengdu University of TCM

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

frequency of migraine attacks

to assess the frequency of migraine attacks at the 16th week after inclusion

Time frame: 16th week after inclusion

Secondary Outcomes

frequency of migraine attacks

to assess the frequency of migraine attacks at the 4th and 24th week respectively

Time frame: 4th and 24th week after inclusion

headache severity

to evaluate the change of severity of headache

Time frame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion

Data from ClinicalTrials.gov

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