Effectiveness of Third Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache (TON-PRF-CH)

January 17, 2026 updated by: Hatice Babaoğlan, Ankara City Hospital Bilkent

Evaluation of the Effectiveness of Third Occipital Nerve Pulsed Radiofrequency Treatment in Patients With Cervicogenic Headache

Cervicogenic headache is a secondary headache disorder originating from cervical spine structures and is frequently associated with chronic pain, functional limitation, and impaired quality of life. The third occipital nerve, which innervates the C2-3 zygapophyseal joint, plays an important role in the pathophysiology of cervicogenic headache.

Pulsed radiofrequency is a minimally invasive interventional pain management technique that modulates nociceptive transmission without causing permanent neural damage. Although third occipital nerve pulsed radiofrequency is increasingly used in clinical practice, prospective data evaluating its clinical effectiveness and safety remain limited.

The aim of this prospective, single-center study is to evaluate the effectiveness and safety of ultrasound-guided third occipital nerve pulsed radiofrequency treatment in patients diagnosed with cervicogenic headache. Pain intensity, headache characteristics, analgesic consumption, and patient-reported outcomes will be assessed before treatment and during follow-up. The results of this study are expected to contribute to clinical evidence supporting interventional treatment strategies for cervicogenic headache.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervicogenic headache is a chronic secondary headache disorder arising from cervical spine structures, particularly the C2-3 zygapophyseal joint and its innervating third occipital nerve. This condition is often resistant to conservative therapies and may significantly impair daily functioning and sleep quality.

Pulsed radiofrequency is a neuromodulatory technique that delivers intermittent high-frequency electrical current while maintaining tissue temperatures below neurodestructive thresholds. This approach is believed to reduce pain by altering nociceptive signal transmission and inflammatory processes without causing permanent nerve injury.

This study is designed as a prospective, single-center, open-label, interventional clinical study conducted at the Algology Clinic of Ankara City Hospital Bilkent. Adult patients aged 18 years and older who are diagnosed with cervicogenic headache according to the International Classification of Headache Disorders (ICHD-3) criteria and who demonstrate a positive response to ultrasound-guided diagnostic third occipital nerve block will be included.

Eligible patients will undergo ultrasound-guided pulsed radiofrequency treatment of the third occipital nerve at the C2-3 zygapophyseal joint level using standard clinical protocols. Pain intensity will be evaluated using the Visual Analog Scale before the procedure and during follow-up visits at predefined time points. Additional outcome measures will include headache frequency, number of headache days, analgesic medication consumption, impact on daily activities and sleep, and patient-reported global perceived effect.

Follow-up assessments will be conducted at 1, 2, and 3 months after the procedure. All adverse events, complications, and safety-related outcomes associated with diagnostic nerve block and pulsed radiofrequency treatment will be recorded throughout the study period.

The primary objective of this study is to evaluate changes in pain intensity following third occipital nerve pulsed radiofrequency treatment. Secondary objectives include assessment of headache-related disability, medication use, patient satisfaction, and safety outcomes. The findings of this study are expected to provide prospective clinical evidence regarding the effectiveness and safety of third occipital nerve pulsed radiofrequency treatment in patients with cervicogenic headache.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Ankara, Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara City Hospital Bilkent
        • Contact:
          • Ankara Bilkent city hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of cervicogenic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3)
  • Availability of cranial and cervical spine imaging
  • At least 5 headache days per month
  • Inadequate response to pharmacological and/or physical therapy treatments
  • Ability to understand and provide written informed consent
  • Positive response to ultrasound-guided diagnostic third occipital nerve block, defined as at least 50% reduction in pain intensity or patient-reported meaningful improvement

Exclusion Criteria:

  • Secondary headache disorders other than cervicogenic headache according to ICHD-3
  • Signs or symptoms of cervical nerve root irritation and/or spinal stenosis
  • Sensory deficit in the greater occipital nerve dermatome
  • Cranio-cervical structural defects or anatomical abnormalities at or near the target site
  • Local or systemic infection
  • Non-pharmacological headache treatment within the last 3 months (e.g., physical therapy, botulinum toxin A, acupuncture, ozone therapy, cognitive behavioral therapy)
  • Pregnancy or suspected pregnancy
  • Known allergy to local anesthetic agents
  • History of malignancy
  • Known organic disease of the brain or spinal cord
  • History of cranial or cervical surgery within the last 12 months
  • Bleeding or coagulation disorders or use of oral anticoagulant therapy
  • Comorbid conditions that may cause headache (e.g., uncontrolled hypertension, intracranial lesions)
  • Conditions that may interfere with treatment adherence or outcome assessment (e.g., psychiatric disorders, dementia)
  • Request for re-treatment due to development of contralateral pain or other pain conditions during follow-up
  • Refusal to undergo the intervention or withdrawal of consent at any stage of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TON PRF Treatment
Participants diagnosed with cervicogenic headache who demonstrate a positive response to diagnostic third occipital nerve block will receive ultrasound-guided pulsed radiofrequency treatment of the third occipital nerve.
Procedure: Third Occipital Nerve Pulsed Radiofrequency
Ultrasound-guided pulsed radiofrequency treatment applied to the third occipital nerve at the C2-3 zygapophyseal joint level for the management of cervicogenic headache.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity measured by Visual Analog Scale (VAS)
Time Frame: Baseline, and 1, 2, and 3 months after the procedure
Pain intensity will be assessed using the Visual Analog Scale (VAS) to evaluate changes in headache-related pain following third occipital nerve pulsed radiofrequency treatment.
Baseline, and 1, 2, and 3 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of headache days per month
Time Frame: Baseline, and 1, 2, and 3 months after the procedure
The number of days with headache per month will be recorded using patient headache diaries during follow-up.
Baseline, and 1, 2, and 3 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-25-1390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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