Greater Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache

NCT06764433 | Completed

• 2 other identifiers: E1-23-3686turkısh health ministry
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of GON PRF treatment applied with USG-guided proximal technique in patients who do not respond to conservative treatments for cervicogenic headache

Conditions

Headache; Cervicogenic Headache; Occipital Nerve Block; Pulsed Radiofrequency

Keywords

Cervical pain; Visual Analog Scale; headache; interventional; pulsed radiofrequency treatment; secondary headache disorders; spinal nerves

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Average headache severity, maximum headache severity, number of headache days (monthly) measured with a visual analog scale (VAS; 10-point VAS scoring, 0 being no pain and 10 being the highest pain intensity that can be tolerated)

  3 months

Study Arms (1)

Clinical data of the patients before and after treatment will be compared

OTHER

According to the International Classification of Headache Disorders (ICHD)-III diagnostic criteria, patients diagnosed with cervicogenic headache will undergo a proximal technique C2 level greater occipital nerve (GON) diagnostic block under ultrasound (USG) guidance, and patients with a positive response (≥50% reduction in pain or positive effect) will receive GON-PRF treatment with the same technique. This study mainly aims to evaluate the clinical efficacy and safety of GON PRF treatment applied at the C2 level under USG guidance in cervicogenic headache during the follow-up period. Our secondary aim is to determine the effects of the GON PRF treatment we applied on the analgesic drug consumption, daily life activities and sleep of the volunteers, how they generally perceive this treatment and whether there is a need for any additional treatment.

Procedure: GONPRF; Procedure: Proximal GONPRF

Interventions

GONPRF PROCEDURE

GON PRF treatment, which we apply by imaging the target nerve and surrounding structures with the proximal technique (at C2 level) under USG guidance in patients who do not respond to conservative treatments for cervicogenic headache.

Clinical data of the patients before and after treatment will be compared

Proximal GONPRF PROCEDURE

Ultrasound-guided pulsed radiofrequency treatment of the greater occipital nerve at the C2 level

Clinical data of the patients before and after treatment will be compared

Eligibility Criteria

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

You may qualify if:

• Diagnosed with cervicogenic headache according to ICHD-3 criteria
• Cranial and cervical spine imaging is available
• Number of headache days per month 5 and/or more
• Inadequate benefit from pharmacological treatments or physical therapy methods used
• Volunteer patients who can understand and approve the treatment and the informed consent form and who can comply with the treatment

You may not qualify if:

• History of secondary headache other than cervicogenic headache according to ICHD-3 criteria
• Cervical nerve root irritation and/or spinal stenosis symptoms and signs
• Sensory deficit findings in the greater occipital nerve dermatome
• Craniocervical defect or other anatomical abnormality in the target area or nearby the procedure
• Local or systemic infection
• Received nonpharmacological treatment within the last 3 months (physical therapy, botulinum toxin A, acupuncture, ozone, cognitive behavioral therapy, etc.)
• Pregnancy or suspected pregnancy
• Known allergy to local anesthetic drugs
• History of malignancy
• Known organic disease of the brain and spinal cord
• History of cranial/cervical surgery within the last 1 year
• Bleeding-clotting disorder or oral anticoagulant use
• Comorbid disease that may cause headache (uncontrolled hypertension, intracranial lesion, etc.)
• Compliance with treatment and treatment results diseases that may affect the evaluation (psychiatric disorder, dementia, etc.)
• Those who request re-treatment due to the emergence of contralateral pain or other types of pain during the follow-up period after treatment

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)

• Gabrhelik T, Michalek P, Adamus M. Pulsed radiofrequency therapy versus greater occipital nerve block in the management of refractory cervicogenic headache - a pilot study. Prague Med Rep. 2011;112(4):279-87.

  PMID: 22142523 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Headache; Post-Traumatic Headache; Neck Pain; Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof dr

Model Details: Single-center, prospective, comparative, observational study

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: March 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)