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NCT Number: NCT04636359

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

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.

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongzhimen Hospital

Beijing, 100007, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Headache Intensity

    Time frame: Change from Visual Analogue Scale at 1 months.

    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.

  2. Headache Days

    Time frame: Change from the number of day at 1 months.

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

  3. Headache Frequency

    Time frame: Change from the times of headache attack at 1 months.

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

  4. Dataset of functional magnetic resonance imaging on brain

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

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

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

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

    One of the clinical measurement. The higher value represents the worse quality of sleep.

  2. Medical Outcomes Study Short-Form 36 questionnaire

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

    One of the clinical measurement. The value range is 0 to 10, the higher value represents the better quality of life.

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine

Other

Registry information

Official study title

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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