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

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

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.

Study Overview

• Status: Completed
• Conditions: Migraine Without Aura
• Intervention / Treatment: Behavioral: Acupuncture stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100007
    • Dongzhimen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long term course of migraine patient without aura; Patients in this group have the history of migraine without aura more than 5 years.	Behavioral: 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).
Experimental: 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.	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	One of the clinical measurement. The higher value represents the worse quality of sleep.	Change from the value of Pittsburgh Sleep Quality Index at 1 months.
Medical Outcomes Study Short-Form 36 questionnaire	One of the clinical measurement. The value range is 0 to 10, the higher value represents the better quality of life.	Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 months.

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Yi Ren, Doctor, Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Acupuncture; Functional magnetic resonance imaging
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine without Aura
• Other Study ID Numbers: BeijingUCM-KWu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

The data of this study includes two aspect, data of brain scans and data of clinical symptom scales. The latter data will be shared to other researchers who contact us via email. The former data, however, is a DICOM format data that hard to analysis in non specialists. Besides, the size of DICOM data is much big that we haven't enough funding to support it in website. Thus, we haven't decided to share this kind of dataset. Except for those data, other data within our study is willing to be share.

Our email: clancy_wu@bucm.edu.cn; clancy_wu@126.com; clancy.wu94@gmail.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No