Acupuncture for Migraine Prophylaxis

Not Applicable

Completed

• Conditions: Migraine Without Aura; Unilateral Headache
• Interventions: Other: acupuncture

• Registration Number: NCT01687660
• Lead Sponsor: Li ying

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.

Study Timeline

• Study First Submitted: 2012-08-31
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 249

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham-acupoint group	acupuncture	sham-acupoint will be penetrated for migraine prophylaxis.
acupoint-meridian group	acupuncture	Apply traditional acupuncture to prevent the migraine attack according to TCM theory

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
headache severity	0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion	to evaluate the change of severity of headache
frequency of migraine attacks	4th and 24th week after inclusion	to assess the frequency of migraine attacks at the 4th and 24th week respectively

Trial Locations

Locations (1)

Chengdu University of TCM; 🇨🇳 Chengdu, Sichuan, China