Tests two pulsed radiofrequency voltage levels for chronic migraine

Trial details

Who runs it

Minia University

Trial code

NCT07500558

Record updated

16 June 2026

Original description

* 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.Read full original descriptionShow less

Ultrasound Guided Sphenopalatine Ganglion Supravoltage Versus Standard Voltage Pulsed Radiofrequency for Pain Alleviation in Chronic Refractory Migraine. Randomized Double Blind Study

* 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.

Inclusion: 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; Failure of ≥2 classes of preventive pharmacological migraine medications (e.g., beta-blockers, antiepileptics, antidepressants...) to get clinically meaningful response ( defined as ≥50% reduction in monthly migraine days), at standard therapeutic doses (Beta-blockers (e.g., propranolol ≥160 mg/day, metoprolol ≥100 mg/day, Antiepileptics (e.g., topiramate ≥100 mg/day, valproate ≥500 mg/day, Tricyclic antidepressants (e.g., amitriptyline ≥50 mg/day, SNRIs (e.g., venlafaxine ≥150 mg/day ) for at least 8 weeks or ≥12 weeks in case of CGRP ); Stable preventive migraine therapy for at least 4 weeks prior to enrollment; MIDAS score ≥11 indicating moderate to severe disability; Ability and willingness to maintain a daily headache diary throughout the study period; Ability to provide written informed consent. Positive response (≥50% pain reduction within 30-60 minutes) to diagnostic INFRATEMPORAL sphenopalatine ganglion block using 2% lidocaine (2 mL) infrazygomatic approach.

Exclusion: Medication Overuse Headache per ICHD-3: Simple analgesics (acetaminophen, NSAIDs, non-opioid analgesics) used on ≥15 days per month for >3 months, OR Triptans, ergot derivatives, opioids, or combination analgesics used on ≥10 days per month for >3 months; Any prior SPG block, PRF, radiofrequency thermocoagulation, chemical neurolysis, or neurostimulation of SPG/trigeminal system within 6 month; No prior occipital or supra-orbital nerve radiofrequency, cryotherapy, or chemical neurolysis within 3 months; Use of botulinum toxin (Botox) within 3 months or CGRP monoclonal antibodies within 3 months prior to enrollment; Any secondary headache disorder ( cluster headache, hemiplegic migraine, migraine with brainstem aura (distinct pathophysiology); chronic tension-type headache >10 days/month; Active psychosis, bipolar disorder (current manic/depressive episode), severe depression with suicidal ideation, dementia, or substance use disorder (DSM-5 criteria) within 12 months; PHQ-9 ≥20 or cognitive impairment affecting reporting reliability; Cardiac pacemaker, ICD, neurostimulator, or cochlear implant; or ECT; Chronic uncontroled hypertension ; history of stroke, intracranial aneurysm, or high risk for cardiovascular events; Pregnancy or lactation, Initiation, discontinuation, or modification of hormonal contraceptive therapy within 3 months prior to enrollment; Coagulopathy (platelets <100,000 or INR >1.5) or ongoing anticoagulation not safely withheld; -Patient refusal.

ClinicalTrials.gov NCT07500558