Central Sensitization and Migraine Disability Following Greater Occipital Nerve Pulsed Radiofrequency: A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ankara City Hospital Bilkent
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Central Sensitization Inventory (CSI) Total Score
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Greater Occipital Nerve Pulsed Radiofrequency
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.
Intervention: Greater occipital nerve radiofrequency (Procedure)
Outcomes
Primary Outcomes
Change in Central Sensitization Inventory (CSI) Total Score
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Gülçin Babaoğlu
Medical doctor, pain specialist
Ankara City Hospital Bilkent