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Impact of GON PRF on Central Sensitization in Migraine Patients

NCT07343427 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-06-01
Completion
2026-09-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343427 on ClinicalTrials.gov