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Chronic Migraine HeadachePhase 4NCT07780136

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

A Phase 4 study testing Ultrasound-guided pulsed radiofrequency (PRF) and OnabotulinumtoxinA in people with Chronic Migraine Headache, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Migraine Headache
What is being tested?
Ultrasound-guided pulsed radiofrequency (PRF) and OnabotulinumtoxinA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 2026
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.

Who cannot join

  • • 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.

About this study

Official title: Comparison of the Effectiveness of Greater Occipital Nerve and Supratrochlear Nerve Pulsed Radiofrequency Versus Botulinum Toxin Type A Injection in Chronic Migraine

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.

Read more

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.

Being tested
Ultrasound-guided pulsed radiofrequency (PRF), OnabotulinumtoxinA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-guided pulsed radiofrequency (PRF)Procedure or surgery

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

  • OnabotulinumtoxinADrug

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

Study groups in NCT07780136
Study groupRoleWhat they receive
Group AActive comparatorUltrasound-guided pulsed radiofrequency (PRF) of the greater occipital nerve (GON) and supratrochlear nerve.
Receives: Procedure: Ultrasound-guided pulsed radiofrequency (PRF)
Group BActive comparatorOnabotulinumtoxinA (Botulinum Toxin Type A) injection according to the PREEMPT injection protocol.
Receives: Drug: OnabotulinumtoxinA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of monthly migraine days

    the mean number of monthly migraine days (MMD)

    Measured: aseline to 12 weeks and 24 weeks post-intervention,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780136
Sponsor's protocol ID
GON+Radiofrequency VSBTMigrain
Status last verified
Sep 2026
First submitted
19 Aug 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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