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

Migraine Without Aura Clinical Trial

Official title:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04636359
• Other study ID #: BeijingUCM-KWu
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: February 1, 2020

Study information

• Verified date: November 2020
• Source: Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine without Aura

Intervention

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).

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Headache Days	The days when headache attacked. The increased day represents the worse headache.	Change from the number of day at 1 months.
Primary	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.
Primary	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	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.
Secondary	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.