Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standarad group | Active Comparator | • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. |
|
| Supravoltage group | Active Comparator | • Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standarad PRF | Device | • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of population with ≥50% reduction in VAS score from pre-interventional values | VAS 1-3 MILD PAIN 4-5= MODERATE >6 SEVERE PAIN A day is counted as a migraine day if: Headache lasts ≥4 hours OR Shorter but treated with migraine-specific medication (e.g., triptan) | 1 week, 1 month, 3,6 months POST INTERVENTIONAL |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving ≥50% reduction in monthly migraine days from baseline MMD is determined using a 4-week prospective headache diary prior. | A day is counted as a migraine day if: Headache lasts ≥4 hours OR Shorter but treated with migraine-specific medication (e.g., triptan) | 1,2,3,4,5,6 MONTHS POST INTERVENTIONAL |
Not provided
Inclusion Criteria:
Diagnosis of chronic migraine according to International Classification of Headache Disorders criteria (≥15 headache days/month for >3 months, including ≥8 migraine days/month) documented by Completion of 4-week prospective baseline headache diary immediately preceding randomization
Exclusion Criteria:
Coagulopathy (platelets <100,000 or INR >1.5) or ongoing anticoagulation not safely withheld.
-Patient refusal.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia university raouf | Recruiting | Minya | 61511 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
| Supravoltage PRF | Device | • Supravoltage PRF parameters: Higher voltage than standard (e.g., 60-70 V), with same frequency, pulse width, and duration, maintaining temperature ≤42°C to avoid nerve damage. |
|
| procedure related complications |
Local: bleeding, hematoma, infection Neurological: facial numbness, dysesthesia, neuralgia Autonomic: lacrimation, nasal congestion Auditory: tinnitus Serious adverse events: intracranial injury, vascular injury |
| UP TO 6 months |
| NUMBER OF DAYS OF ACUTE MEDICATIONS USE REPORTED MONTHLY | A medication-use day was defined as any day on which at least one dose of acute migraine medication was taken, regardless of the number of doses." | 1,2,3,4,5,6 MONTHS |
| Minia university | Recruiting | Minya | 61511 | Egypt |
|
| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided