Comparing Unilateral and Bilateral Proximal GONPRF in Migraine Treatment

NCT06894121 | Active Not Recruiting DMC

• 1 other identifier: TABED 1-24-763 TABED 1-26-214
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Headache Disorders; Migraine, Greater Occipital Nerve Pulsed Radiofrequency; Ultrasound Guided Nerve Block

Keywords

GON PRF; Migraine Treatment; Headache Pain Management; Ultrasound-Guided GON Pulsed Radiofrequency

Outcome Measures

Primary Outcomes (1)

• Change in monthly headache days

  Description: Monthly headache days defined as calendar days with headache lasting ≥4 hours with at least moderate intensity, or any headache requiring acute migraine medication use. Note: Primary outcome definition updated from VAS score to monthly headache days per the study protocol. VAS scores are retained as secondary outcomes.

  Baseline and 6 months after treatment

Secondary Outcomes (6)

• Change in Headache Intensity (VAS)

  Baseline, 1 month, 3 months, and 6 months after treatment

• Change in MIDAS Score

  Baseline, 3 months, and 6 months after treatment

• Change in Headache Impact Test-6 (HIT-6)Score

  Baseline, 3 months, and 6 months after treatment

• Global Perceived Effect (GPE)

  1 month, 3 months, and 6 months after treatment

• Acute Medication Use Days

  Baseline and monthly follow-up for 6 months

Study Arms (2)

Unilateral GON PRF Treatment

OTHER

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)

Bilateral GON PRF Treatment

EXPERIMENTAL

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:

Interventions

Bilateral GON PRF Treatment: OTHER

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

Also known as: BGON-PRF

Bilateral GON PRF Treatment

Greater Occipital Nerve Pulsed Radiofrequency (Unilateral) OTHER

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.

Also known as: UGON-PRF

Unilateral GON PRF Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Health Sciences University, Ankara Bilkent City Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Sukriye Dadali, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: This study will have two arms comparing the efficacy of unilateral GON PRF treatment with bilateral GON PRF treatment. The clinical outcomes of the treatment methods in each arm will be evaluated.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: December 18, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)