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MigraineGON PRF-CSNCT07343427

Impact of GON PRF on Central Sensitization in Migraine Patients

A study testing Greater occipital nerve radiofrequency in people with Migraine and Central Sensitization, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine, Central Sensitization
What is being tested?
Greater occipital nerve radiofrequency
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 1 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, Ankara, 06810

Other trials in Turkey (Türkiye)

About this study

Official title: Central Sensitization and Migraine Disability Following Greater Occipital Nerve Pulsed Radiofrequency: A Prospective Observational Study

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.

Read more

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.

Read the detailed description

Migraine is a highly prevalent neurological disorder associated with substantial disability, reduced quality of life, and significant socioeconomic burden. Increasing evidence indicates that migraine chronification is closely linked to central sensitization, characterized by enhanced excitability of central nociceptive pathways, impaired pain modulation, and the clinical manifestation of cutaneous allodynia. Persistent central sensitization is considered a key mechanism underlying increased attack frequency, treatment refractoriness, and migraine-related disability.

The greater occipital nerve (GON), originating from the dorsal ramus of the C2 spinal nerve, provides sensory innervation to the occipital region and has direct anatomical and functional connections with the trigeminocervical complex. Modulation of afferent input from the GON has been shown to influence trigeminal nociceptive processing, supporting its role as a therapeutic target in migraine and other primary headache disorders. Although GON blocks may reduce headache burden, their effects are typically transient, highlighting the need for longer-lasting neuromodulatory strategies.

Pulsed radiofrequency (PRF) is a minimally destructive neuromodulation technique that delivers short bursts of high-voltage electrical current while maintaining tissue temperatures below neurodestructive thresholds. Unlike continuous radiofrequency ablation, PRF is believed to exert its effects through neuromodulatory mechanisms rather than structural nerve injury. Previous studies have suggested that GON-targeted PRF may reduce headache frequency and intensity; however, data regarding its effects on central sensitization and sensory amplification in migraine remain limited.

This prospective observational study is designed to evaluate changes in central sensitization, cutaneous allodynia, and migraine-related disability following ultrasound-guided GON pulsed radiofrequency in patients with episodic or chronic migraine. Adult patients meeting International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for migraine and scheduled for GON PRF as part of routine clinical care will be enrolled. All procedures will be performed under sterile operating room conditions using ultrasound guidance to identify the GON between the obliquus capitis inferior and semispinalis capitis muscles. PRF will be applied with standardized parameters, maintaining electrode tip temperature at or below 42°C.

Participants will undergo clinical assessments at baseline and at 1 and 3 months after the procedure. Central sensitization will be 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). In addition, monthly moderate and severe headache days and acute migraine medication use will be recorded. Adverse events related to the procedure will be systematically monitored throughout the follow-up period.

By prospectively evaluating sensory and clinical outcomes over time, this study aims to provide detailed observational data on the potential neuromodulatory effects of GON pulsed radiofrequency on central sensitization and migraine-related disability. The findings are expected to contribute to a better understanding of patient-reported sensory changes following GON PRF and to inform future controlled studies investigating neuromodulation-based interventions in migraine.

Being tested
Greater occipital nerve radiofrequency
Keywords
Migraine, Central sensitization, Greater occipital nerve, Pulsed radiofrequency
Medical subject headings
Migraine Disorders

What participants receive

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

  • Greater occipital nerve radiofrequencyProcedure or surgery

    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 groups in NCT07343427
Study groupRoleWhat they receive
Greater Occipital Nerve Pulsed RadiofrequencyExperimentalParticipants 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.
Receives: Procedure: Greater occipital nerve radiofrequency

What is being measured

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

  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.

    Measured: Baseline to 3 months after greater occipital nerve pulsed radiofrequency

Secondary outcomes (4)
  1. Change in Allodynia Symptom Checklist (ASC-12) Score

    The Allodynia Symptom Checklist-12 (ASC-12) is a patient-reported outcome measure assessing the presence and severity of cutaneous allodynia during migraine attacks. The total score ranges from 0 to 24, with higher scores indicating more severe allodynia symptoms. This outcome is defined as the change in ASC-12 total score from baseline to 1 month and 3 months of follow-up.

    Measured: Baseline to 1 month and 3 months after the procedure

  2. Change in Migraine Disability Assessment Scale (MIDAS) Score

    The Migraine Disability Assessment (MIDAS) questionnaire evaluates headache-related disability over the past 3 months by quantifying the impact of migraines on work, household, and social activities. The total MIDAS score ranges from 0 to 270, with higher scores indicating greater migraine-related disability. This outcome is defined as the change in MIDAS total score from baseline to 1 month and 3 months of follow-up.

    Measured: Baseline to 1 month and 3 months after the procedure

  3. Change in Acute Migraine Medication Use

    Change in the number of days per month requiring acute migraine medication.

    Measured: Baseline to 1 month and 3 months after the procedure

  4. Adverse Events

    Frequency and type of procedure-related adverse events recorded throughout the follow-up period.

    Measured: Up to 3 months after the procedure

Timeline

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

  1. First posted15 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Sep 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343427
Sponsor's protocol ID
TABED 2-25-979
Acronym
GON PRF-CS
Status last verified
Jan 2026
First submitted
7 Jan 2026
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38915302
  • 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.

    PubMed 36101891
  • 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.

    PubMed 38493795

Questions about this trial

What is this clinical trial studying?

A study testing Greater occipital nerve radiofrequency in people with Migraine and Central Sensitization, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Central Sensitization Inventory (CSI) Total Score (time frame: Baseline to 3 months after greater occipital nerve pulsed radiofrequency). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07343427, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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