NCT07366060

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 17, 2026

Last Update Submit

January 17, 2026

Conditions

Third Occipital NerveCervicogenic Headache

Keywords

cervicogenic headachePulsed RadiofrequencyThird Occipital NerveTON PRF

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity measured by Visual Analog Scale (VAS)

    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 Outcomes (1)

  • Number of headache days per month

    Baseline, and 1, 2, and 3 months after the procedure

Study Arms (1)

TON PRF Treatment

EXPERIMENTAL

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

Interventions

Third Occipital Nerve Pulsed RadiofrequencyPROCEDURE

Ultrasound-guided pulsed radiofrequency treatment applied to the third occipital nerve at the C2-3 zygapophyseal joint level for the management of cervicogenic headache.

TON PRF Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Kim ED, Kim YH, Park CM, Kwak JA, Moon DE. Ultrasound-guided Pulsed Radiofrequency of the Third Occipital Nerve. Korean J Pain. 2013 Apr;26(2):186-90. doi: 10.3344/kjp.2013.26.2.186. Epub 2013 Apr 3.

    PMID: 23614084RESULT

  • Lord SM, Barnsley L, Wallis BJ, Bogduk N. Third occipital nerve headache: a prevalence study. J Neurol Neurosurg Psychiatry. 1994 Oct;57(10):1187-90. doi: 10.1136/jnnp.57.10.1187.

    PMID: 7931379RESULT

  • Bogduk N. The clinical anatomy of the cervical dorsal rami. Spine (Phila Pa 1976). 1982 Jul-Aug;7(4):319-30. doi: 10.1097/00007632-198207000-00001.

    PMID: 7135065RESULT

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Hatice Babaoğlan

CONTACT

0533 7783642haticebabaoglan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive ultrasound-guided third occipital nerve pulsed radiofrequency treatment, and outcomes will be compared with baseline measurements during follow-up.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)