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

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.

Conditions

• Chronic Migraine Headache

Interventions

PROCEDURE

Ultrasound-guided pulsed radiofrequency (PRF)

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

DRUG

OnabotulinumtoxinA

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

Sponsors & Collaborators

• Assiut University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2026-10-31

Completion

2026-12-31

FDA Drug

Yes