* PRF performed on the sphenopalatine ganglion level under ultrasound guidance. * Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C. * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
• Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.
• 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.
Proportion of participants achieving ≥50% reduction in monthly migraine days from baseline 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)
Time frame: 3 MONTHS POST INTERVENTIONAL
mean change in VAS SCORE
VAS 1-3 MILD PAIN 4-5= MODERATE \>6 SEVERE PAIN
Time frame: 1 week, 1,3,6 MONTHS
proportion of population with ≥50% reduction in VAS score from preinterventional values
VAS 1-3 MILD PAIN 4-5= MODERATE \>6 SEVERE PAIN
Time frame: 1 week, 1 month, 3,6 months POST INTERVENTIONAL
MIDAS score
Score Disability Level 0-5 Minimal 6-10 Mild 11-20 Moderate ≥21 Severe disability
Time frame: Baseline, 3 months (primary meaningful comparison) and 6 months
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
Time frame: UP TO 6 months
Proportion of participants achieving ≥50% reduction in monthly migraine days from baseline Baseline MMD is determined using a 4-week prospective headache diary
A day is counted as a migraine day if: Headache lasts ≥4 hours OR Shorter but treated with migraine-specific medication (e.g., triptan)
Time frame: 1, 6 MONTHS POST INTERVENTIONAL
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HIT-6 score
≤49 Little or no impact 50-55 Some impact 56-59 Substantial impact * 60 Severe impact ≤49 Little or no impact 50-55 Some impact 56-59 Substantial impact * 60 Severe impact
Time frame: 1, 3,6 months post interventional
patient global outcome of change (PGIC)
Score Meaning 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse Score Responders = PGIC 1-2 Non-responders = PGIC ≥3
Time frame: 3,6 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."
Time frame: 1,2,3,4,5,6 MONTHS