Migraine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for refractory migraine defined by the International Headache Society (IHS). 2. Age 18 to 75 years old, either gender. 3. Failure of treatment with >=3 classes of migraine preventive medications. 4. Positive nerve block test (pain relief >= 80%). 5. Voluntary participation in this study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Secondary headache caused by organic diseases such as intracranial tumor, infection, cerebrovascular malformation or trauma. 2. Severe cardiac, hepatic, renal or coagulation dysfunction, unable to tolerate surgery and anesthesia. 3. Pregnant or lactating women. 4. Mental illness or cognitive impairment that prevents cooperation in the study and follow-up. 5. Participation in other clinical intervention studies within the past 3 months. 6. Other conditions judged by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with =50% reduction in monthly headache days (MHD) at 12 months postoperatively.;=30% improvement in Headache Impact Test (HIT?6) score.;Success rate of medication overuse headache (MOH) withdrawal (target >80%).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) score: complete pain relief rate (VAS =1) and overall effective rate (VAS reduction =50%).;Migraine Disability Assessment Scale (MIDAS) score and analgesic medication consumption.;36?Item Short Form Health Survey (SF?36) score.;Incidence of surgical complications (paresthesia, incision infection, etc.).;Patient satisfaction score (NRS).; | — |
Countries
China
Contacts
Xiamen University Affiliated Zhongshan Hospital