Ultrasound Guided Infratemporal Sphenopalatine Ganglion Supravoltage Versus Standard Voltage Pulsed Radiofrequency for Pain Alleviation in Chronic Refractory Migraine.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Migraine, Headache
• Intervention / Treatment: Device: Standarad PRF; Device: Supravoltage PRF

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

  • 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 Criteria:

• 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 secondary headache disorder ( cluster headache, hemiplegic migraine, migraine with brainstem aura (distinct pathophysiology); chronic tension-type headache >10 days/month.
• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standarad group; • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.	Device: Standarad PRF; • Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.
Active Comparator: Supravoltage group; • 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.	Device: Supravoltage PRF; • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 MONTHS POST INTERVENTIONAL

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean change in VAS SCORE	VAS 1-3 MILD PAIN 4-5= MODERATE >6 SEVERE PAIN	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	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	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	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)	1, 6 MONTHS POST INTERVENTIONAL
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	1, 3,6 months post interventional
patient global outcome of change (PGIC)	Score Meaning; Very much improved; Much improved; Minimally improved; No change; Minimally worse; Much worse; Very much worse Score Responders = PGIC 1-2 Non-responders = PGIC ≥3	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."	1,2,3,4,5,6 MONTHS

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2026
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): April 2, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache
• Other Study ID Numbers: R/740

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No