Impact of GON PRF on Central Sensitization in Migraine Patients

NCT07343427 · tracked via the Priya Life Science Turkey tracker

Sponsor

Ankara City Hospital Bilkent

Phase

Not applicable

Started

2026-02-01

Last updated

2026-05-12

Condition(s) studied

MigraineCentral Sensitization

Investigational drug(s) / intervention(s)

Greater occipital nerve radiofrequency

Greater occipital nerve radiofrequency: Ultrasound-guided pulsed radiofrequency will be applied to the greater occipital nerve under sterile operating room conditions. Participants will be positioned prone with the neck in flexion. Using a linear ultrasound transducer, the greater occipital nerve will be identified in the fascial plane between the obliquus capitis inferior and semispinalis capitis muscles at the C2 level. A 22-gauge radiofrequency cannula with a 5-mm active tip will be advanced using an in-plane technique toward the target nerve. Correct positioning will be confirmed by sensory stimulation at low voltage. Pulsed radiofrequency will be delivered at 45 V for 360 seconds with a pulse frequency of 5 Hz and pulse width of 5 ms, while maintaining the electrode tip temperature at or below 42°C. Participants will be monitored during and after the procedure according to standard clinical practice.

Study summary

Background: Central sensitization and cutaneous allodynia are key mechanisms implicated in migraine chronification and disability. Pulsed radiofrequency (PRF) of the greater occipital nerve (GON) has emerged as a neuromodulatory intervention for refractory headache disorders; however, its effects on central sensitization remain insufficiently characterized.

Objective: To prospectively evaluate changes in central sensitization, allodynia, and migraine-related disability following GON pulsed radiofrequency in patients with migraine.

Methods: In this prospective observational study, adult patients with episodic or chronic migraine undergoing ultrasound-guided GON pulsed radiofrequency were evaluated at baseline and at 1 and 3 months post-procedure. Central sensitization was assessed using the Central Sensitization Inventory (CSI), cutaneous allodynia using the Allodynia Symptom Checklist (ASC-12), and migraine-related disability using the Migraine Disability Assessment Scale (MIDAS). Monthly headache days and acute medication use were also recorded.

Results: Changes in CSI, ASC-12, MIDAS scores, headache frequency, and acute medication use over follow-up were analyzed using repeated-measures statistical methods.

Conclusions: This study provides prospective data on sensory and clinical outcomes following GON pulsed radiofrequency, contributing to the understanding of its potential role in modulating central sensitization in migraine.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Adults aged 18 years or older Diagnosis of episodic or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) Planned to undergo ultrasound-guided greater occipital nerve pulsed radiofrequency as part of routine clinical care Ability to complete self-reported questionnaires (CSI, ASC-12, MIDAS) Willingness and ability to provide written informed consent Exclusion Criteria: * Presence of other primary headache disorders (e.g., cluster headache, tension-type headache as the primary diagnosis) Secondary headache disorders, including headache attributed to structural, infectious, inflammatory, or vascular causes Prior greater occipital nerve pulsed radiofrequency treatment within the past 12 months History of cervical spine surgery, significant cervical trauma, or structural pathology that may interfere with the procedure Known coagulopathy or current use of anticoagulant therapy that cannot be safely interrupted Local infection at or near the planned injection site Severe uncontrolled psychiatric or neurological disorders that may impair study participation or questionnaire reliability Pregnancy or breastfeeding Inability to comply with follow-up visits or study procedures

Primary outcome measure(s)

Change in Central Sensitization Inventory (CSI) Total Score — Baseline to 3 months after greater occipital nerve pulsed radiofrequency
Change in central sensitization symptoms assessed using the Central Sensitization Inventory (CSI), a validated 25-item self-reported questionnaire with scores ranging from 0 to 100, where higher scores indicate greater symptom severity.

Trial sites (1)

Facility	City	Region	Status
Ankara Bilkent City Hospital	Ankara	Ankara

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07343427 on ClinicalTrials.gov ↗ ← All trials in Turkey