Acupuncture for Migraine Prophylaxis (AMP)

A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment

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.

Study Overview

• Status: Completed
• Conditions: Migraine Without Aura; Unilateral Headache
• Intervention / Treatment: Other: acupuncture

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 Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Chengdu University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: acupoint-meridian group; Apply traditional acupuncture to prevent the migraine attack according to TCM theory	Other: acupuncture; apply acupuncture to prevent the migraine attack
Other: sham-acupoint group; sham-acupoint will be penetrated for migraine prophylaxis.	Other: acupuncture; apply acupuncture to prevent the migraine attack
No Intervention: waiting list; No acupuncture nor other methods will be conducted in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of migraine attacks	to assess the frequency of migraine attacks at the 16th week after inclusion	16th week after inclusion

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
acupuncture expectation scale	an outcome to indicate the expectation of patient towards acupuncture treatment for migraine	1 day

Collaborators and Investigators

• Sponsor: Li ying
• Collaborators: Chongqing Medical University; Hunan University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Fanrong Liang, Professor, Chengdu University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378.
• Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: acupuncture; migraine prophylaxis
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Migraine without Aura
• Other Study ID Numbers: 2012CB518501-2