None listed
Conditions
Interventions
Procedure/Surgery : MRI Scanning and Acupuncture Treatment Protocol
1. MRI equipment
Scanner: 3T MRI, Skyra, Siemens
2. Imaging protocol
Scan preparation: After placing the participant in the head c
single acupoint of GV20 and both sides of acupoints of GB20, EX-HN5, LI4, TE3, LR3, GB41. In addition, Ashi points at the site of pain may be selected as appropriate, and the acupoint prescription ma
Sponsors
Catholic Kwandong University International St.Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Right-handed adults aged 19 to 50 years 2) Able and willing to provide written informed consent 3) Diagnosed with migraine without aura according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) 4) History of migraine for at least 6 months 5) At least 2 headache attacks per month during the past 3 months 6) Average headache pain intensity of 4 or higher on the visual analog scale (VAS) during the past 3 months
Exclusion criteria
Exclusion criteria: 1) Secondary headache disorders, such as headache related to hemorrhage, thrombosis, or vascular malformation 2) Receipt of acupuncture treatment or use of migraine preventive medication within the past 3 months 3) Participation in another clinical trial within 30 days prior to screening, or current participation in another clinical trial 4) History of severe alcohol or substance abuse 5) Pregnant or breastfeeding 6) History of head trauma accompanied by loss of consciousness 7) Persistent cough or uncontrolled tremor 8) Unsuitable for MRI according to MRI safety criteria 9) Hypersensitivity to acupuncture treatment, including skin hypersensitivity 10) Considered unsuitable for study participation in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in migraine days between baseline and the end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of treatment in migraine duration;Change from baseline in migraine intensity (Visual Analog Scale: 0–10) at the end of treatment;Proportion of responders (patients achieving a 50% reduction from baseline in headache days at the end of treatment);Change from baseline in the amount of rescue medication used at the end of treatment;Change from baseline in questionnaire scores, including migraine-specific quality of life(MSQoL), at the end of treatment (MIDAS[Migraine Disability Assessment Test], HIT-6[Headache Impact Test-6], PSS[Perceived Stress Scale], PHQ-9[Patient Health Questionnaire-9], GAD-7[Generalized Anxiety Disorder-7]);Analysis of brain neuroimaging data using Magnetic Resonance Imaging (MRI) | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Yong Park
Catholic Kwandong University International St.Mary's Hospital
Outcome results
None listed