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

NCT04636359 | Completed DMC

• 1 other identifier: BeijingUCM-KWu
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Without Aura

Keywords

Acupuncture; Functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (4)

• Headache Intensity

  The headache intensity is measured by the value of Visual Analogue Scale which limits 1 to 10. The higher value of this scale represents the worse headache.

  Change from Visual Analogue Scale at 1 months.

• Headache Days

  The days when headache attacked. The increased day represents the worse headache.

  Change from the number of day at 1 months.

• Headache Frequency

  The maximum times in one day during the headache attacked. The increased time represents the worse headache.

  Change from the times of headache attack at 1 months.

• Dataset of functional magnetic resonance imaging on brain

  Dataset of functional magnetic resonance imaging on brain includes functional images, structural images and diffusion tensor images.

  Changes from the dataset of subject's brain area at 1 months.

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index

  Change from the value of Pittsburgh Sleep Quality Index at 1 months.

• Medical Outcomes Study Short-Form 36 questionnaire

  Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 months.

Study Arms (2)

Long term course of migraine patient without aura

EXPERIMENTAL

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

Behavioral: Acupuncture stimulation

Short term course of migraine patient without aura

EXPERIMENTAL

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

Behavioral: Acupuncture stimulation

Interventions

Acupuncture stimulation 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).

Long term course of migraine patient without aura; Short term course of migraine patient without aura

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (1)

Dongzhimen Hospital

Beijing, 100007, China

Location

MeSH Terms

Conditions

Migraine without Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yi Ren, Doctor

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Neurology

Model Details: Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 19, 2020
• Study Start: October 30, 2017
• Primary Completion: December 30, 2019
• Study Completion: February 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)