Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT07068451
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Greater Occipital Nerve Block Alone Versus Dual Nerve Block in Cervicogenic Headache and Occipital Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-07-06', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity measured by the Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 24 hours, 3 weeks, and 3 months post-intervention', 'description': 'ain intensity was assessed using a 10-point Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst pain imaginable. VAS scores were recorded at baseline and follow-up visits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ervicogenic Headache (CEH)', 'Occipital Neuralgia (ON)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/29368949/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study looked at two types of nerve block injections used to treat people with cervicogenic headache (CEH) and occipital neuralgia (ON)-two painful conditions that often cause pain at the back of the head and neck. The injections target nerves in the upper neck that may be causing the pain.\n\nThe researchers compared:\n\nOne nerve injection (greater occipital nerve block, or GONB), versus\n\nTwo nerve injections (GONB plus lesser occipital nerve block, or LONB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Adults aged 18 to 65 years\n\nClinical diagnosis of cervicogenic headache (CEH) and/or occipital neuralgia (ON) according to ICHD-3 criteria\n\nPain duration of more than 3 months\n\nPain localized to the occipital region, consistent with the distribution of the greater and/or lesser occipital nerves\n\nInadequate response to conservative therapy (e.g., analgesics, physiotherapy)\n\nWillingness to participate and provide written informed consent\n\nExclusion Criteria:\n\nPrevious nerve block or other interventional procedures for headache\n\nUse of systemic corticosteroids within the past 3 months\n\nKnown allergy to lidocaine or other amide-type local anesthetics\n\nEvidence of secondary causes of headache on imaging (e.g., tumor, infection)\n\nPregnancy or breastfeeding\n\nActive infection at the injection site\n\nCoagulopathy or use of anticoagulant therapy\n\nSignificant psychiatric or neurological comorbidities interfering with study participation'}, 'identificationModule': {'nctId': 'NCT07068451', 'briefTitle': 'Greater Occipital Nerve Block Alone Versus Dual Nerve Block in Cervicogenic Headache and Occipital Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'Tishreen University Hospital'}, 'officialTitle': 'A Prospective Randomized Study Comparing Greater Occipital Nerve Block Alone Versus Dual Nerve Blockade in the Management of Cervicogenic Headache and Occipital Neuralgia', 'orgStudyIdInfo': {'id': 'N/2020-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GONB Alone', 'description': 'Patients received a single injection of 1 mL of 2% lidocaine at the greater occipital nerve using a landmark-guided technique.', 'interventionNames': ['Procedure: Greater Occipital Nerve Block (GONB)']}, {'type': 'EXPERIMENTAL', 'label': 'GONB + LONB (Dual Block)', 'description': 'Patients receive two injections of 1 mL of 2% lidocaine each at the greater and lesser occipital nerves using a landmark-guided technique.', 'interventionNames': ['Procedure: Combined Greater and Lesser Occipital Nerve Block (GONB + LONB)']}], 'interventions': [{'name': 'Greater Occipital Nerve Block (GONB)', 'type': 'PROCEDURE', 'otherNames': ['Drug: Lidocaine 2%'], 'description': 'A landmark-guided injection of 1 mL of 2% lidocaine administered at the anatomical location of the greater occipital nerve (GON) to treat cervicogenic headache and occipital neuralgia. Performed without corticosteroids or imaging guidance.', 'armGroupLabels': ['GONB Alone']}, {'name': 'Combined Greater and Lesser Occipital Nerve Block (GONB + LONB)', 'type': 'PROCEDURE', 'otherNames': ['Drug: Lidocaine 2%'], 'description': 'Two landmark-guided injections of 1 mL of 2% lidocaine each at the anatomical locations of the greater and lesser occipital nerves. Performed without corticosteroids or imaging, targeting broader nerve involvement in cervicogenic headache and occipital neuralgia.', 'armGroupLabels': ['GONB + LONB (Dual Block)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Latakia', 'country': 'Syria', 'facility': 'Latakia', 'geoPoint': {'lat': 35.53125, 'lon': 35.79088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tishreen University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ali Hammed', 'investigatorAffiliation': 'Tishreen University Hospital'}}}}