Acupuncture for Migraine Prophylaxis

Migraine Without Aura Clinical Trial

— AMP  

Official title:

A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687660
• Other study ID #: 2012CB518501-2
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine without Aura
• Unilateral Headache

Intervention

Other:
• acupuncture
apply acupuncture to prevent the migraine attack

Locations

Country	Name	City	State
China	Chengdu University of TCM	Chengdu	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
Li ying	Chongqing Medical University, Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)	to observe the change of MSQ	the day of inclusion and 4th week after inclusion
Other	acupuncture expectation scale	an outcome to indicate the expectation of patient towards acupuncture treatment for migraine	1 day
Primary	frequency of migraine attacks	to assess the frequency of migraine attacks at the 16th week after inclusion	16th week after inclusion
Secondary	frequency of migraine attacks	to assess the frequency of migraine attacks at the 4th and 24th week respectively	4th and 24th week after inclusion
Secondary	headache severity	to evaluate the change of severity of headache	0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion