Comparing Unilateral and Bilateral Proximal GONPRF in Migraine Treatment ((UBGON-PRF))

Comparison of the Efficacy of Unilateral and Bilateral Proximal Greater Occipital Nerve Pulsed Radiofrequency in the Treatment of Migraine

This study is designed to compare the clinical effectiveness of unilateral and bilateral Greater Occipital Nerve Pulsed Radiofrequency (GON-PRF) treatment at the C2 level in patients with migraine. The procedure will be guided by ultrasound and will focus on evaluating how each technique affects migraine symptoms.

The main goal of this study is to assess the impact of both unilateral and bilateral GON-PRF treatments on migraine relief. Additionally, the secondary objectives of this study include evaluating the effects of these treatments on migraine-related disability and comparing any potential side effects or complications that may occur during the treatments.

This research will help us understand which technique may be more effective and provide more information on the safety of these treatments.

Study Overview

• Status: Completed
• Conditions: Headache Disorders; Ultrasound Guided Nerve Block; Migraine, Greater Occipital Nerve Pulsed Radiofrequency
• Intervention / Treatment: Other: Greater Occipital Nerve Pulsed Radiofrequency (Unilateral); Other: Bilateral GON PRF Treatment:

Detailed Description

Migraine is a common neurological disorder that significantly affects quality of life and socio-economic functioning. In patients with headaches resistant to conservative pharmacological treatment, peripheral nerve interventions, particularly greater occipital nerve (GON) block, are frequently used. GON block can reduce the frequency and intensity of migraine attacks and may decrease the need for systemic medications. However, the duration of benefit following GON block with local anesthetics and steroids is often limited to several weeks or months.

To prolong the therapeutic effect of peripheral nerve interventions, pulsed radiofrequency (PRF) has been introduced. PRF modulates pain transmission by generating an electrical field around the targeted nerve without causing structural nerve damage. Greater occipital nerve pulsed radiofrequency (GON PRF) has been reported to be both effective and safe in the treatment of migraine and is widely used in pain management practice.

GON block and GON PRF procedures can be performed using anatomical landmark techniques or under ultrasound guidance. Two ultrasound-guided approaches have been described: a proximal technique targeting the nerve at the C2 vertebral level and a distal technique targeting the superior nuchal line. The proximal (C2) approach has been shown to provide effective results in migraine treatment.

Although the exact mechanism of long-term headache relief following peripheral nerve interventions remains unclear, it is believed to involve central pain modulation. The upper cervical nerve roots are anatomically and functionally connected with trigeminal pathways, converging within the trigeminocervical complex. Neurophysiological findings suggest that unilateral nerve interventions may produce bilateral inhibitory effects through modulation of second-order neuronal transmission.

Retrospective clinical observations indicate that unilateral GON interventions may provide similar reductions in headache frequency, severity, and duration compared to bilateral applications, with potentially fewer side effects. However, there is currently no prospective study directly comparing unilateral and bilateral GON PRF in patients with migraine.

In our clinic, GON PRF is performed under sterile operating room conditions with standard monitoring and intravenous access. For the proximal (C2) approach, patients are positioned prone with slight neck flexion. Under ultrasound guidance, anatomical landmarks including the obliquus capitis inferior and semispinalis capitis muscles are identified. The GON is visualized as an oval hypoechoic structure between these muscles. A 22-gauge RF cannula with a 5 mm active tip is inserted using an in-plane technique. After sensory stimulation confirms appropriate localization, PRF is applied at 45 V, 5 Hz, and 5 ms pulse width for 360 seconds, ensuring that electrode tip temperature does not exceed 42°C. No medications are injected during the PRF procedure. For bilateral treatment, the same procedure is performed contralaterally. Patients are observed for at least one hour post-procedure prior to discharge.

The primary objective of this study is to prospectively compare the clinical efficacy of unilateral and bilateral ultrasound-guided proximal (C2 level) GON PRF treatment in patients with migraine. Secondary objectives include evaluation of migraine-related disability outcomes and assessment of treatment-related adverse events and complications.

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Cankaya
    • Ankara, Cankaya, Turkey (Türkiye), 06800
      • Health Sciences University, Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 65 years
• Followed at the Algology outpatient clinic of Ankara Bilkent City Hospital
• Diagnosis of episodic migraine (≥5 attacks per month) or chronic migraine according to ICHD-3 criteria
• Inadequate response to migraine preventive medications
• Not currently using preventive migraine medication OR no change in medication and/or dosage within the last 3 months
• No bleeding or coagulation disorders
• No active infection
• Not pregnant and not suspected of pregnancy
• No history of craniocervical surgery affecting the intervention area
• Able to understand the study and provide written informed consent
• Able to comply with study procedures and follow-up

Exclusion Criteria:

• Diagnosis of primary headache other than migraine according to ICHD-3 criteria
• Fewer than 5 migraine attacks per month
• Headache secondary to comorbid conditions (e.g., uncontrolled hypertension, intracranial lesions)
• Interventional migraine treatment within 3 months prior to GON-PRF
• Botulinum toxin injection within 3 months prior to GON-PRF
• Non-pharmacological migraine treatment (e.g., acupuncture, physical therapy, ozone therapy, cognitive behavioral therapy) within 3 months prior to GON-PRF
• Withdrawal of consent at any stage of the study
• Failure to attend follow-up visits
• Development of any condition that meets exclusion criteria during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Unilateral GON PRF Treatment; This arm involves applying unilateral greater occipital nerve pulsed radiofrequency (GON PRF) at the C2 level using ultrasound guidance. The procedure is performed on one side of the head (unilateral).	Other: Greater Occipital Nerve Pulsed Radiofrequency (Unilateral); Greater Occipital Nerve (GON) Pulsed Radiofrequency (PRF) treatment is performed under sterile conditions in the operating room. The patient is positioned in the prone position with neck flexion. Under ultrasound guidance at the proximal (C2) level, the needle is carefully placed near the GON, targeting the space between the Obliquus Capitis Inferior (OCI) muscle and C2's bifid spinous process. After proper sterilization, a linear ultrasound probe is used transversely over the occipital protuberance to locate the C1 and C2 vertebrae. Once identified, the RF needle and electrode are inserted laterally to medially using in-plane technique. A sensory stimulation test is done, and the PRF therapy is applied at a 45V setting, 5 Hz, and 5 ms pulse width for 360 seconds, with a maximum temperature of 42°C. No drug injections are administered during the procedure. Post-procedure, the patient is monitored for at least 1 hour before discharge after a general and neurological evaluation.; Other Names: UGON-PRF
Experimental: Bilateral GON PRF Treatment; This arm involves applying bilateral greater occipital nerve pulsed radiofrequency (GON PRF) at the C2 level using ultrasound guidance. The procedure is performed on both sides of the head (bilateral).	Other: Bilateral GON PRF Treatment: Greater Occipital Nerve (GON) Pulsed Radiofrequency (PRF) treatment is performed under sterile conditions in the operating room. The patient is positioned in the prone position with neck flexion. Under ultrasound guidance at the proximal (C2) level, the needle is carefully placed near the GON, targeting the space between the Obliquus Capitis Inferior (OCI) muscle and C2's bifid spinous process. After proper sterilization, a linear ultrasound probe is used transversely over the occipital protuberance to locate the C1 and C2 vertebrae. Once identified, the RF needle and electrode are inserted laterally to medially using in-plane technique. A sensory stimulation test is done, and the PRF therapy is applied at a 45V setting, 5 Hz, and 5 ms pulse width for 360 seconds, with a maximum temperature of 42°C. No drug injections are administered during the procedure. Post-procedure, the patient is monitored for at least 1 hour before discharge after a general and neurological evaluation. Bilater; Other Names: BGON-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in monthly headache days from baseline to 6 months	Monthly headache days are defined as calendar days with headache lasting ≥4 hours with at least moderate intensity, or any headache requiring acute migraine medication use. Note: The primary outcome was defined as monthly headache days according to the study protocol. VAS scores are retained as secondary outcomes.	Baseline and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Medication Use Days	Number of days in which acute migraine medications (e.g., analgesics, NSAIDs, triptans, ergot derivatives, opioids) were used to relieve headache.	Baseline and monthly follow-up for 6 months
Adverse Events	Any adverse events or complications related to unilateral or bilateral GON PRF treatment, including type, severity, and duration.	Up to 6 months after treatment
Change in Headache Intensity (VAS)	Average headache intensity measured using a 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity (worse outcome).	Baseline, 1 month, 3 months, and 6 months after treatment
Change in MIDAS Grade	The Migraine Disability Assessment (MIDAS) questionnaire assesses headache-related disability over the previous 3 months by quantifying days of missed work, household, and social activities. In this study, MIDAS was recorded as categorical grades (Grade I-IV), with higher grades indicating greater disability. Changes from baseline to follow-up time points will be analyzed.	Baseline, 3 months, and 6 months after treatment
Change in Headache Impact Test-6 (HIT-6) Score	The Headache Impact Test-6 (HIT-6) questionnaire assesses the impact of headaches on daily functioning. The total score ranges from 36 to 78, with higher scores indicating greater headache-related impact (worse outcome). Changes from baseline to follow-up time points will be analyzed.	Baseline, 3 months, and 6 months after treatment
Global Perceived Effect (GPE)	The 7-point Global Perceived Effect (GPE) scale is a patient-reported measure of overall change in headache symptoms and functional status. Scores range from 1 (very much worse) to 7 (very much improved), with higher scores indicating greater clinical improvement. A score of ≥6 is considered to represent clinically meaningful improvement.	1 month, 3 months, and 6 months after treatment

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Sukriye Dadali, M.D., Ankara City Hospital Bilkent

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine Treatment; GON PRF; Headache Pain Management; Ultrasound-Guided GON Pulsed Radiofrequency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Migraine Disorders; Headache Disorders
• Other Study ID Numbers: TABED 1-24-763 TABED 1-26-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers due to confidentiality constraints and data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No