Acupuncture for Migraine Prophylaxis

NCT ID: NCT01687660

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Migraine Without Aura; Unilateral Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

acupoint-meridian group

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

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

apply acupuncture to prevent the migraine attack

sham-acupoint group

sham-acupoint will be penetrated for migraine prophylaxis.

Group Type: OTHER

acupuncture

Intervention Type: OTHER

apply acupuncture to prevent the migraine attack

waiting list

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

acupuncture

apply acupuncture to prevent the migraine attack

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Chongqing Medical University

OTHER

Sponsor Role: collaborator

Li ying

OTHER

Sponsor Role: lead

Responsible Party

Li ying

Chengdu University of Traditional Chinese Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fanrong Liang, Professor

Role: PRINCIPAL_INVESTIGATOR

Chengdu University of Traditional Chinese Medicine

Locations

Chengdu University of TCM

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28241154 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24171782 (View on PubMed)

Other Identifiers

2012CB518501-2

Identifier Type: -

Identifier Source: org_study_id