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Not yet recruitingNCT07780136Updated Sep 22, 2026

Effectiveness of Greater Occipital Nerve and Supratrochlear Nerve Pulsed Radiofrequency Versus Botulinum Toxin Type A Injection in Chronic Migraine

A Phase 4 interventional study of Ultrasound-guided pulsed radiofrequency (PRF) and OnabotulinumtoxinA in Chronic Migraine Headache, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Migraine is a common chronic neurovascular disorder ranked among the leading causes of disability worldwide, and its global burden has continued to rise over the past three decades, with prevalence increasing substantially between 1990 and 2021the global number of prevalent cases, incident cases, and DALYs for migraine increased by 58%, 42%, and 58% respectively from 1990 to 2021 (1). In 2021, migraine affected an estimated 1.2 billion people globally, and although tension-type headache was more prevalent, migraine caused greater disability (2). Chronic migraine, defined as headache occurring on 15 or more days per month for more than three months, with migrainous features on at least 8 days, represents a particularly disabling subtype that is frequently refractory to standard pharmacological prophylaxis (3). Pharmacologic treatment of chronic migraine often has limited efficacy, prompting growing interest in interventional and peripheral neuromodulatory approaches (4).

OnabotulinumtoxinA is currently the only FDA-approved interventional prophylactic therapy for chronic migraine, with efficacy established by class-one evidence from the PREEMPT clinical program (5). Although onabotulinumtoxinA is traditionally known for inhibiting muscle contraction, its efficacy in chronic migraine is now attributed to inhibition of SNARE-mediated vesicle trafficking in sensory as well as motor nerve terminals (6). However, treatment with onabotulinumtoxinA, while effective, must be repeated every three months for sustained relief and can impose a significant financial burden on patients (7), which has driven exploration of alternative peripheral procedures targeting the same pericranial sensory nerve distribution.

Greater occipital nerve block and PRF have shown efficacy in reducing migraine frequency, intensity, and duration, with pulsed radiofrequency treatment thought to reduce conduction in nociceptive fibers through a neuromodulatory, non-neurodestructive mechanism (8). Randomized data comparing GON block with GON-PRF found that VAS pain scores were significantly lower in the PRF group than the GON block group at six months follow-up (9), and longer-term cohort data have shown durable benefit of GON-targeted radiofrequency techniques over twelve months of follow-up (10). Beyond the occipital nerve, radiofrequency ablation of pericranial nerves including the supratrochlear and supraorbital nerves has emerged as a promising option for headache conditions refractory to pharmacologic treatment, with a favorable and largely self-limited side-effect profile (7). Case reports have further demonstrated good therapeutic response to PRF in patients whose chronic migraine remained refractory even after botulinum toxin injection (10).

Despite this growing evidence base, direct head-to-head comparisons between combined GON-supratrochlear nerve PRF and onabotulinumtoxinA injection, the two leading peripheral interventional strategies covering the trigeminal and occipital sensory distribution, remain scarce. Given the cost, repeated dosing requirement, and resource burden associated with botulinum toxin therapy, and the emerging durability data for PRF, a direct comparative study is warranted to determine which modality offers superior and more sustained efficacy, better safety, and greater cost-effectiveness for patients with chronic migraine.

02

Conditions studied

  • Chronic Migraine Headache
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • Age between 18 and 65 years, either sex.

      • Diagnosis of chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (headache occurring on ≥15 days/month for >3 months, with migrainous features on ≥8 days/month).
      • Inadequate response, intolerance, or contraindication to at least one standard oral preventive medication (e.g., amitriptyline, propranolol, topiramate, flunarizine, valproate).
      • Stable dose of any concurrent prophylactic medication for at least 4 weeks prior to enrolment, with no planned change during the study period.
      • Willingness and ability to complete headache diaries and follow-up visits.

Exclusion criteria

Exclusion Criteria:

    • Other primary headache disorders (tension-type headache, cluster headache, hemicrania continua) as the predominant headache type.

      • Secondary headache due to an identifiable structural, infectious, vascular, or neoplastic cause (confirmed or suspected by history/imaging).
      • Prior botulinum toxin injection or radiofrequency procedure for headache within the last 6 months.
      • Known hypersensitivity or allergy to botulinum toxin or to local anesthetics.
      • Pregnancy or lactation.
      • Neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome).
      • Medication overuse headache not resolved prior to enrolment.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Active comparator
    Group A

    Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve.

    Procedure: Ultrasound-guided pulsed radiofrequency (PRF)

  • Active comparator
    Group B

    OnabotulinumtoxinA (Botulinum Toxin Type A) injection according to the PREEMPT injection protocol.

    Drug: OnabotulinumtoxinA

Interventions

  • ProcedureUltrasound-guided pulsed radiofrequency (PRF)

    Ultrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve.

  • DrugOnabotulinumtoxinA

    OnabotulinumtoxinA (Botulinum Toxin Type A) injection according to the PREEMPT injection protocol.

05

What researchers measure

Primary outcomes

  1. number of monthly migraine days

    the mean number of monthly migraine days (MMD)

    Time frame: aseline to 12 weeks and 24 weeks post-intervention,

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07780136
Lead sponsor
Assiut University
Responsible party
Kamal Eldin Mohamed Ali Ahmed (residant doctor at Assiut university hospital, Assiut University) — Principal investigator
First posted
Aug 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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