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Acupuncture for Migraine Prophylaxis (AMP)

Primary Purpose

Migraine Without Aura, Unilateral Headache

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Li ying
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Without Aura focused on measuring acupuncture, migraine prophylaxis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

No Intervention

Arm Label

acupoint-meridian group

sham-acupoint group

waiting list

Arm Description

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

sham-acupoint will be penetrated for migraine prophylaxis.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

frequency of migraine attacks
to assess the frequency of migraine attacks at the 4th and 24th week respectively
headache severity
to evaluate the change of severity of headache

Full Information

First Posted
August 31, 2012
Last Updated
February 13, 2020
Sponsor
Li ying
Collaborators
Hunan University of Traditional Chinese Medicine, Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01687660
Brief Title
Acupuncture for Migraine Prophylaxis
Acronym
AMP
Official Title
A Continuous Study on Abiding Effect of Acupuncture for Migraine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li ying
Collaborators
Hunan University of Traditional Chinese Medicine, Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura, Unilateral Headache
Keywords
acupuncture, migraine prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupoint-meridian group
Arm Type
Experimental
Arm Description
Apply traditional acupuncture to prevent the migraine attack according to TCM theory
Arm Title
sham-acupoint group
Arm Type
Other
Arm Description
sham-acupoint will be penetrated for migraine prophylaxis.
Arm Title
waiting list
Arm Type
No Intervention
Arm Description
No acupuncture nor other methods will be conducted in this group.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
apply acupuncture to prevent the migraine attack
Primary Outcome Measure Information:
Title
frequency of migraine attacks
Description
to assess the frequency of migraine attacks at the 16th week after inclusion
Time Frame
16th week after inclusion
Secondary Outcome Measure Information:
Title
frequency of migraine attacks
Description
to assess the frequency of migraine attacks at the 4th and 24th week respectively
Time Frame
4th and 24th week after inclusion
Title
headache severity
Description
to evaluate the change of severity of headache
Time Frame
0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion
Other Pre-specified Outcome Measures:
Title
MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1)
Description
to observe the change of MSQ
Time Frame
the day of inclusion and 4th week after inclusion
Title
acupuncture expectation scale
Description
an outcome to indicate the expectation of patient towards acupuncture treatment for migraine
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanrong Liang, Professor
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28241154
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.
Results Reference
derived
PubMed Identifier
24171782
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.
Results Reference
derived

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Acupuncture for Migraine Prophylaxis

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