Impact of GON PRF on Central Sensitization in Migraine Patients

NCT07343427 | Not Yet Recruiting DMC

• 1 other identifier: TABED 2-25-979
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Migraine; Central Sensitization

Keywords

Migraine; Central sensitization; Greater occipital nerve; Pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• Change in Central Sensitization Inventory (CSI) Total Score

  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.

  Baseline to 3 months after greater occipital nerve pulsed radiofrequency

Secondary Outcomes (4)

• Change in Allodynia Symptom Checklist (ASC-12) Score

  Baseline to 1 month and 3 months after the procedure

• Change in Migraine Disability Assessment Scale (MIDAS) Score

  Baseline to 1 month and 3 months after the procedure

• Change in Acute Migraine Medication Use

  Baseline to 1 month and 3 months after the procedure

• Adverse Events

  Up to 3 months after the procedure

Study Arms (1)

Greater Occipital Nerve Pulsed Radiofrequency

EXPERIMENTAL

Participants assigned to this arm will undergo ultrasound-guided pulsed radiofrequency of the greater occipital nerve as part of routine clinical care. The procedure will be performed under sterile operating room conditions with standardized pulsed radiofrequency parameters, maintaining electrode tip temperature at or below 42°C. Clinical and patient-reported outcomes will be assessed at baseline and at 1 and 3 months following the intervention.

Procedure: Greater occipital nerve radiofrequency

Interventions

Greater occipital nerve radiofrequency PROCEDURE

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.

Greater Occipital Nerve Pulsed Radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Related Publications (3)

• Oliveira K, Dhondt N, Englesakis M, Goel A, Hoydonckx Y. Pulsed Radiofrequency Neuromodulation of the Greater Occipital Nerve for the Treatment of Headache Disorders in Adults: A Systematic Review. Can J Pain. 2024 May 15;8(1):2355571. doi: 10.1080/24740527.2024.2355571. eCollection 2024.

  PMID: 38915302 RESULT

• Suzuki K, Suzuki S, Shiina T, Kobayashi S, Hirata K. Central Sensitization in Migraine: A Narrative Review. J Pain Res. 2022 Sep 7;15:2673-2682. doi: 10.2147/JPR.S329280. eCollection 2022.

  PMID: 36101891 RESULT

• GBD 2021 Nervous System Disorders Collaborators. Global, regional, and national burden of disorders affecting the nervous system, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024 Apr;23(4):344-381. doi: 10.1016/S1474-4422(24)00038-3. Epub 2024 Mar 14.

  PMID: 38493795 RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, pain specialist

Model Details: This is a single-group, prospective interventional study in which all enrolled participants undergo ultrasound-guided pulsed radiofrequency of the greater occipital nerve as part of routine clinical care. Clinical and patient-reported outcomes are assessed at baseline and at 1 and 3 months following the intervention to evaluate within-subject changes over time. No control or comparator group is included.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share