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

NCT07500558 | Not Yet Recruiting

• 1 other identifier: R/740
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Chronic Migraine, Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• mean change in VAS SCORE

  1 week, 1,3,6 MONTHS

• proportion of population with ≥50% reduction in VAS score from preinterventional values

  1 week, 1 month, 3,6 months POST INTERVENTIONAL

• MIDAS score

  Baseline, 3 months (primary meaningful comparison) and 6 months

• procedure related complications

  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

  1, 6 MONTHS POST INTERVENTIONAL

Study Arms (2)

standarad group

ACTIVE COMPARATOR

• Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.

Device: Standarad PRF

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.

Device: Supravoltage PRF

Interventions

Standarad PRF DEVICE

• Standard voltage PRF parameters: 45 V, 5 Hz frequency, 5 ms pulse width, 360 seconds duration, electrode temperature ≤42°C.

standarad group

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.

Supravoltage group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass professor anesthesia and pain

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): April 2, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03