search
Back to results

Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
manual acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring acupuncture, migraine, specific acupoints, brain network

Eligibility Criteria

17 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004

Exclusion Criteria:

  • people with other types of headache
  • people with organic cerebral disorders
  • people with primary disorders
  • people in moderate or severe anxiety or depression
  • people in pregnancy

Sites / Locations

  • Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

No Intervention

Arm Label

specific points of Bladder meridian and Shanjiao meridian

non-specific points of Bladder meridian and Shanjiao meridian

specific points of Stomach meridian

non-acupoints

waiting list

Arm Description

In traditional Chinese acupuncture theory, Bladder meridian and Shanjiao meridian have been considered as the main pathological meridian location of migraine. Meanwhile, specific points on both meridians have been used widely in its treatment for a long time.

Non-specific points of Shaoyang meridians are also used in cure of migraine. It is conventionally thought to be less effective using non-specific points than specific ones.

Specific points of Stomache meridian for migraine were searched in Chinese ancient data. And this group is set to compare with specific points of Shaoyang meridians for their possible different brain networks.

Three non-acupoints were chosen,two of which were located on the arm and one one the leg.

Outcomes

Primary Outcome Measures

improvement of headache frequency

Secondary Outcome Measures

Full Information

First Posted
June 27, 2010
Last Updated
November 25, 2014
Sponsor
Chengdu University of Traditional Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01152632
Brief Title
Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study
Official Title
Acupuncture Treatment for Migraine: a Functional Magnetic Resonance Imaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Selecting acupoints along meridians is the predominant principle in acupuncture treatment, and it is also considered to ensure acupuncture efficacy. This experiment is to investigate whether specific brain networks gradually come in formation in accordance with this kind of acupoint selection methods.
Detailed Description
Every participants in the four intervention groups will go through functional magnetic imaging (fMRI) scan four times: the 1st scan will be performed at their baselines; the 2nd scan will be done after 2 courses (10 times) acupuncture treatment; the 3rd scan will be performed when the 4 courses end; the 4th scan will be operated after three-month enrollment. Volunteers in waiting list group will undergo the above scans at the same time points in exception of acupuncture treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
acupuncture, migraine, specific acupoints, brain network

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
specific points of Bladder meridian and Shanjiao meridian
Arm Type
Experimental
Arm Description
In traditional Chinese acupuncture theory, Bladder meridian and Shanjiao meridian have been considered as the main pathological meridian location of migraine. Meanwhile, specific points on both meridians have been used widely in its treatment for a long time.
Arm Title
non-specific points of Bladder meridian and Shanjiao meridian
Arm Type
Experimental
Arm Description
Non-specific points of Shaoyang meridians are also used in cure of migraine. It is conventionally thought to be less effective using non-specific points than specific ones.
Arm Title
specific points of Stomach meridian
Arm Type
Active Comparator
Arm Description
Specific points of Stomache meridian for migraine were searched in Chinese ancient data. And this group is set to compare with specific points of Shaoyang meridians for their possible different brain networks.
Arm Title
non-acupoints
Arm Type
Placebo Comparator
Arm Description
Three non-acupoints were chosen,two of which were located on the arm and one one the leg.
Arm Title
waiting list
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
manual acupuncture
Other Intervention Name(s)
acupuncture
Intervention Description
thirty minutes duration every time, five times per week for one course, a total four courses
Primary Outcome Measure Information:
Title
improvement of headache frequency
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of non-aura Migraine formulated by the international headache society in 2004 Exclusion Criteria: people with other types of headache people with organic cerebral disorders people with primary disorders people in moderate or severe anxiety or depression people in pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanrong Liang, Master
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33287704
Citation
Li Z, Zhou J, Lan L, Cheng S, Sun R, Gong Q, Wintermark M, Zeng F, Liang F. Concurrent brain structural and functional alterations in patients with migraine without aura: an fMRI study. J Headache Pain. 2020 Dec 7;21(1):141. doi: 10.1186/s10194-020-01203-5.
Results Reference
derived

Learn more about this trial

Acupuncture for Migraine: a Functional Magnetic Resonance Imaging (fMRI) Study

We'll reach out to this number within 24 hrs