- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764433
Greater Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache (GONPRFCEH)
Efficacy of Greater Occipital Nerve Pulsed Radiofrequency Treatment at C2 Level in Cervicogenic Headache
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cankaya
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Ankara, Cankaya, Turkey (Türkiye), 06800
- Health Sciences University, Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
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 |
|---|---|
|
Other: 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. |
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.
Ultrasound-guided pulsed radiofrequency treatment of the greater occipital nerve at the C2 level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 3 months
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E1-23-3686
- turkısh health ministry (Other Identifier: Bilkent Ankara City Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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