Greater Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache

NCT ID: NCT06764433

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-01

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

Detailed Description

In our study, GON PRF will be applied to volunteers who are diagnosed with cervicogenic headache according to ICHD-3 criteria, who meet the study criteria and who report a positive effect with diagnostic GON block application. The main purpose of our study is to evaluate the clinical efficacy and safety of ultrasound-guided C2 level greater occipital nerve pulsed radiofrequency treatment in cervicogenic headache during the follow-up period. Our secondary purpose is to determine the effects of the GON PRF treatment we applied on the volunteers' analgesic drug consumption, daily life activities and sleep, how they generally perceive this treatment and whether there is a need for any additional treatment.

Conditions

Headache, Cervicogenic; Cervicogenic Headache

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: OTHER

GONPRF

Intervention Type: 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.

Proximal GONPRF

Intervention Type: PROCEDURE

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

Interventions

GONPRF

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.

Intervention Type: PROCEDURE

Proximal GONPRF

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Those who do not accept treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Ülkü Sabuncu

assoc prof dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Sciences University, Ankara Bilkent City Hospital

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 22142523 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/31337167/

Related Info

Other Identifiers

turkısh health ministry

Identifier Type: OTHER

Identifier Source: secondary_id

E1-23-3686

Identifier Type: -

Identifier Source: org_study_id