Clinical trial NCT04636359: Study the Effect of Acupuncture on Migraine Patient Without Aura Via Functional Magnetic Resonance Imaging.
Official title: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Keywords: Acupuncture
Functional magnetic resonance imaging
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two experimental groups with different condition receive identical intervention, with control group as baseline for comparison.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache Intensity
timeFrame: Change from Visual Analogue Scale at 1 months.
measure: Headache Days
timeFrame: Change from the number of day at 1 months.
measure: Headache Frequency
timeFrame: Change from the times of headache attack at 1 months.
measure: Dataset of functional magnetic resonance imaging on brain
timeFrame: Changes from the dataset of subject's brain area at 1 months.
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from the value of Pittsburgh Sleep Quality Index at 1 months.
measure: Medical Outcomes Study Short-Form 36 questionnaire
timeFrame: Change from the value of Medical Outcomes Study Short-Form 36 questionnaire at 1 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Yi Ren, Doctor
role: PRINCIPAL_INVESTIGATOR
References: