The Study of Efficacy and Central Mechanism of Acupuncture Treatment in Patients With Migraine Based on the Theory of Gen-Jie
- Conditions
- Migraine
- Registration Number
- ITMCTR2000003410
- Lead Sponsor
- Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion criteria for MwoA
1.Diagnosed as migraine without aura according to the diagnostic criteria specified by the ICHD-III, IHS 2018
2.Male and female adults aged 18–65, right handed
3.Initial onset of migraines prior to the age of 50 years
4.Experience of acute migraine attacks at a frequency of 2 to 8, but less than 15 days of attacks per month during the previous 3 months and during baseline measurement
5.Experience of migraine attacks for at least 1 year
6.Provision of written, informed consent by the patients.
Inclusion criteria for HC
1.Male and female adults aged 18–65with a normal physical examination and without any family history of sever diseases
2.No history of neurological diseases, and no major physical diseases and trauma history
3.Right handed, roughly matched with the sex, age and education of the MwoA participants selected
4.Without any contraindications for MRI scans, such as pacemakers, cardiac defibrillators, cochlear implants or claustrophobia
1. Patients with headache caused by organic diseases;
2. Patients with nervous system disease, immune deficiency, hemorrhagic disease or allergy;
3. Patients who had used drugs to control migraine attack within 1 month before admission;
4. Patients with alcohol or other drug abuse;
5. Patients participating in other clinical trials at the same time;
6. Pregnant or lactating women, or patients who plan to be pregnant within 6 months;
7. Patients with any contraindications (such as pacemakers, aneurysm clips, artificial heart valves, ear implants or metal fragments, eyes, skin or body foreign matters) on MRI.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brain functional magnetic resonance data;Change in the frequency of migraine attacks;
- Secondary Outcome Measures
Name Time Method The self-rating anxiety scale [SAS];Change in Visual analogue scale (VAS) for headache;number of migraine days;Migraine-specific quality-of-life questionnaire (MSQ);acute medication intake;The self-rating depression scale[SDS];number of participants with adverse events (AEs) and serious adverse events (SAEs);