Clinical trial NCT01687660: Acupuncture for Migraine Prophylaxis
Official title: A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Unilateral Headache
Keywords: acupuncture
migraine prophylaxis
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Hunan University of Traditional Chinese Medicine
name: Chongqing Medical University
First posted: 2012-09-19
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: frequency of migraine attacks
timeFrame: 16th week after inclusion
Secondary outcomes:
measure: frequency of migraine attacks
timeFrame: 4th and 24th week after inclusion
measure: headache severity
timeFrame: 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion
Other outcomes:
measure: MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)
timeFrame: the day of inclusion and 4th week after inclusion
measure: acupuncture expectation scale
timeFrame: 1 day
Locations:
city: Chengdu
country: China
facility: Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Fanrong Liang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.