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Migraine, Greater Occipital Nerve Pulsed Radiofrequency(UBGON-PRF)NCT06894121

Comparing Unilateral and Bilateral Proximal GONPRF in Migraine Treatment

A study testing Greater Occipital Nerve Pulsed Radiofrequency (Unilateral) and Bilateral GON PRF Treatment: in people with Migraine, Greater Occipital Nerve Pulsed Radiofrequency and Headache Disorders, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Greater Occipital Nerve Pulsed Radiofrequency (Unilateral) and Bilateral GON PRF Treatment:
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Dec 2024to 1 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Health Sciences University, Ankara Bilkent City Hospital

    Ankara, Cankaya, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Greater Occipital Nerve Pulsed Radiofrequency (Unilateral), Bilateral GON PRF Treatment:
Keywords
GON PRF, Migraine Treatment, Headache Pain Management, Ultrasound-Guided GON Pulsed Radiofrequency
Medical subject headings
Migraine Disorders, Headache Disorders

What participants receive

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

  • Greater Occipital Nerve Pulsed Radiofrequency (Unilateral)Other

    Also called UGON-PRF

    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.

  • Bilateral GON PRF Treatment:Other

    Also called BGON-PRF

    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

Study groups in NCT06894121
Study groupRoleWhat they receive
Unilateral GON PRF TreatmentOtherThis 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).
Receives: Other: Greater Occipital Nerve Pulsed Radiofrequency (Unilateral)
Bilateral GON PRF TreatmentExperimentalThis 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).
Receives: Other: Bilateral GON PRF Treatment:

What is being measured

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

  1. 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.

    Measured: Baseline and 6 months after treatment

Secondary outcomes (6)
  1. 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).

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

  2. 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.

    Measured: Baseline, 3 months, and 6 months after treatment

  3. 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.

    Measured: Baseline, 3 months, and 6 months after treatment

  4. 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.

    Measured: 1 month, 3 months, and 6 months after treatment

  5. 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.

    Measured: Baseline and monthly follow-up for 6 months

  6. Adverse Events

    Any adverse events or complications related to unilateral or bilateral GON PRF treatment, including type, severity, and duration.

    Measured: Up to 6 months after treatment

Timeline

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

  1. First posted25 Mar 2025
  2. Study start18 Dec 2024
  3. Primary completion1 Apr 2026
  4. Study completion1 May 2026

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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06894121
Sponsor's protocol ID
TABED 1-24-763 TABED 1-26-214
Acronym
(UBGON-PRF)
Status last verified
May 2026
First submitted
18 Mar 2025
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared with other researchers due to confidentiality constraints and data protection policies.

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

Questions about this trial

What is this clinical trial studying?

A study testing Greater Occipital Nerve Pulsed Radiofrequency (Unilateral) and Bilateral GON PRF Treatment: in people with Migraine, Greater Occipital Nerve Pulsed Radiofrequency and Headache Disorders, 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 11 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: finished, as of the sponsor's last update on 7 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean change in monthly headache days from baseline to 6 months (time frame: Baseline and 6 months after treatment). 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 NCT06894121, which also lists 1 linked publication.

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 7 May 2026.

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