Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 2:08 PM
Study NCT ID:
NCT06764433
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Greater Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051298', 'term': 'Post-Traumatic Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-center, prospective, comparative, observational study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '3 months', 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervicogenic headache, proximal GON PRF, Ultrasound guided, C2 level'], 'conditions': ['Headache, Cervicogenic', 'Cervicogenic Headache']}, 'referencesModule': {'references': [{'pmid': '22142523', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31337167/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The effect of GON PRF treatment applied with USG-guided proximal technique in patients who do not respond to conservative treatments for cervicogenic headache', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with cervicogenic headache according to ICHD-3 criteria\n* Cranial and cervical spine imaging is available\n* Number of headache days per month 5 and/or more\n* Inadequate benefit from pharmacological treatments or physical therapy methods used\n* Volunteer patients who can understand and approve the treatment and the informed consent form and who can comply with the treatment\n\nExclusion Criteria:\n\n* History of secondary headache other than cervicogenic headache according to ICHD-3 criteria\n* Cervical nerve root irritation and/or spinal stenosis symptoms and signs\n* Sensory deficit findings in the greater occipital nerve dermatome\n* Craniocervical defect or other anatomical abnormality in the target area or nearby the procedure\n* Local or systemic infection\n* Received nonpharmacological treatment within the last 3 months (physical therapy, botulinum toxin A, acupuncture, ozone, cognitive behavioral therapy, etc.)\n* Pregnancy or suspected pregnancy\n* Known allergy to local anesthetic drugs\n* History of malignancy\n* Known organic disease of the brain and spinal cord\n* History of cranial/cervical surgery within the last 1 year\n* Bleeding-clotting disorder or oral anticoagulant use\n* Comorbid disease that may cause headache (uncontrolled hypertension, intracranial lesion, etc.)\n* Compliance with treatment and treatment results diseases that may affect the evaluation (psychiatric disorder, dementia, etc.)\n* Those who request re-treatment due to the emergence of contralateral pain or other types of pain during the follow-up period after treatment\n* Those who do not accept treatment'}, 'identificationModule': {'nctId': 'NCT06764433', 'acronym': 'GONPRF CEH', 'briefTitle': 'Greater Occipital Nerve Pulsed Radiofrequency in Cervicogenic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Efficacy of Greater Occipital Nerve Pulsed Radiofrequency Treatment At C2 Level in Cervicogenic Headache', 'orgStudyIdInfo': {'id': 'E1-23-3686'}, 'secondaryIdInfos': [{'id': 'turkısh health ministry', 'type': 'OTHER', 'domain': 'Bilkent Ankara City Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinical data of the patients before and after treatment will be compared', 'description': '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.\n\nThis 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.\n\nOur 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.', 'interventionNames': ['Procedure: GONPRF', 'Procedure: Proximal GONPRF']}], 'interventions': [{'name': 'GONPRF', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Clinical data of the patients before and after treatment will be compared']}, {'name': 'Proximal GONPRF', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided pulsed radiofrequency treatment of the greater occipital nerve at the C2 level', 'armGroupLabels': ['Clinical data of the patients before and after treatment will be compared']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Cankaya', 'country': 'Turkey (Türkiye)', 'facility': 'Health Sciences University, Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I dont want to.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assoc prof dr', 'investigatorFullName': 'Ülkü Sabuncu', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}