Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07500558

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

* 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia university, Minya, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standarad PRF

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

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.

Primary outcomes

  1. proportion of population with ≥50% reduction in VAS score from pre-interventional values

    Time frame: 1 week, 1 month, 3,6 months POST INTERVENTIONAL

    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)

Secondary outcomes

  1. Proportion of participants achieving ≥50% reduction in monthly migraine days from baseline MMD is determined using a 4-week prospective headache diary prior.

    Time frame: 1,2,3,4,5,6 MONTHS POST INTERVENTIONAL

    A day is counted as a migraine day if:

    Headache lasts ≥4 hours OR

    Shorter but treated with migraine-specific medication (e.g., triptan)

  2. procedure related complications

    Time frame: UP TO 6 months

    Local: bleeding, hematoma, infection

    Neurological: facial numbness, dysesthesia, neuralgia

    Autonomic: lacrimation, nasal congestion

    Auditory: tinnitus

    Serious adverse events: intracranial injury, vascular injury

  3. NUMBER OF DAYS OF ACUTE MEDICATIONS USE REPORTED MONTHLY

    Time frame: 1,2,3,4,5,6 MONTHS

    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."

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.