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Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.

NCT ID: NCT04636359

Last Updated: 2020-11-20

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2020-02-01

Brief Summary

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This study recruits 30 subjects into three groups, including two experimental groups and one control group. The two experimental groups receive acupuncture treatment for 4 weeks and two times functional magnetic resonance imaging scans as well as clinical symptom assessments. The control group receive one scan without any intervention. The aim of this study is to find the whether the effect of acupuncture treatment have diversity among migraineurs with different disease course.

Detailed Description

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This study recruits 10 patients with long course (\> 5 years) without aura migraine, 10 patients with short course (\< 5 years) without aura migraine and 10 healthy volunteers who meet the inclusion and exclusion criteria. Among the study, two migraine patient groups receive acupuncture treatment for 4 weeks, the frequency is 30 minutes each time, three times a week. According to the national standard of the people's Republic of China (GB / T 12346-2006) acupoint name and location, the acupuncture treatment includes SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral) acupoints. Both migraine patients receive scan in functional magnetic resonance imaging (Siemens 3.0T superconducting magnetic resonance scanner, Germany) and symptom scale assessment before the first acupuncture stimulation and post the last acupuncture stimulation. Healthy volunteers receive only one scanning without intervention.

Conditions

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Migraine Without Aura

Keywords

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Acupuncture Functional magnetic resonance imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Long term course of migraine patient without aura

Patients in this group have the history of migraine without aura more than 5 years.

Group Type EXPERIMENTAL

Acupuncture stimulation

Intervention Type BEHAVIORAL

The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).

Short term course of migraine patient without aura

Patients in this group have the history of migraine without aura equal or less than 5 years.

Group Type EXPERIMENTAL

Acupuncture stimulation

Intervention Type BEHAVIORAL

The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).

Interventions

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Acupuncture stimulation

The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Fitting to the standard of migraine without aura in the international classification of headache disease (ICHD-2) issued by the international headache society in 2004.
* Age from 18 to 55, male or female, with right-handedness.
* Having no depression or other serious mental illness.
* Having no psychoactive drugs taken in the past 3 months, or vasoactive drugs in the past 2 weeks.
* Having no habit of taking analgesics from a long time.

Exclusion Criteria

* Having the first headache attack of migraine after 55 years old.
* Having a history of head injury, cluster headache, or other unclassified headaches.
* Taking medicine to prevent migraine in recent 4 weeks.
* Having the serious asymmetry or definite pathological changes in the anatomical structure of the head through the MRI scan.
* Cannot hold on the times of the MRI scan.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yi Ren

Deputy director of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Ren, Doctor

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Locations

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Dongzhimen Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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BeijingUCM-KWu

Identifier Type: -

Identifier Source: org_study_id