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

NCT ID: NCT01152632

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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specific points of Bladder meridian and Shanjiao meridian

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.

Group Type EXPERIMENTAL

manual acupuncture

Intervention Type OTHER

thirty minutes duration every time, five times per week for one course, a total four courses

non-specific points of Bladder meridian and Shanjiao meridian

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.

Group Type EXPERIMENTAL

manual acupuncture

Intervention Type OTHER

thirty minutes duration every time, five times per week for one course, a total four courses

specific points of Stomach meridian

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.

Group Type ACTIVE_COMPARATOR

manual acupuncture

Intervention Type OTHER

thirty minutes duration every time, five times per week for one course, a total four courses

non-acupoints

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

Group Type PLACEBO_COMPARATOR

manual acupuncture

Intervention Type OTHER

thirty minutes duration every time, five times per week for one course, a total four courses

waiting list

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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manual acupuncture

thirty minutes duration every time, five times per week for one course, a total four courses

Intervention Type OTHER

Other Intervention Names

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acupuncture

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fanrong Liang, Master

Role: STUDY_CHAIR

Chengdu University of Traditional Chinese Medicine

Locations

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Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 33287704 (View on PubMed)

Other Identifiers

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30930112/C190301

Identifier Type: -

Identifier Source: org_study_id