Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT04339335
Status:
UNKNOWN
Last Update Posted:
2020-04-09
First Post:
2020-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulsed Radiofrequency in Chronic Headaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-06', 'studyFirstSubmitDate': '2020-04-06', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days with headache', 'timeFrame': '12 months', 'description': 'days with headache per month'}], 'secondaryOutcomes': [{'measure': 'pain during crisis', 'timeFrame': '12 months', 'description': 'pain during crisis with Numeric Rating Scale 0-10'}, {'measure': 'analgesics consumption', 'timeFrame': '12 months', 'description': 'number of analgesics consumption per month'}, {'measure': 'quality of life', 'timeFrame': '12 months', 'description': 'quality of life by EQ5D'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': 'Pulsed radiofrequency of the occipital nerves (greater and lesser) for primary headache management.', 'detailedDescription': 'Patients participating suffered from primary headaches (migraine, cluster, and tension headache) and occipital neuralgia were enrolled in the study. They have all received in the past the standard systemic pharmacotherapy prophylaxis for headache management (with topiramate or amitriptylline) as well as tryptanes for rescue treatment, and were scheduled for a diagnostic nerve block of the occipital nerves in cases of intractable pain. Inclusion criteria included: not adequate response to systemic pharmacotherapy, pain over crises of \\>4/10, occipital tenderness bilaterally or unilaterally, and days with headache of more than 10/month. Exclusion criteria were age\\<18 years old, pregnancy or lactation, presence of cardiac pacemaker, previous therapy with PRF, severe psychiatric disorder and patient refusal. In cases of a positive response to the diagnostic nerve block with local anesthetic, with \\>50% pain relief they were scheduled for pulsed radiofrequency of GON and LON bilaterally.\n\nPrimary outcome measure was the days with headache per month, before and after treatment. In addition, pain during headache crisis (with Visual Analogue Scale, VAS, 0-10), the analgesic consumption (number per month) and the quality of life (measured with EQ6D) were studied. All measurements were performed before treatment, as well as after 1, 3, 6, and 12 months. All patients completed the Brief Pain Inventory questionnaire in Greek language and signed an informed consent prior treatment. All measurements were accomplished by an independed (blinded) researcher of the pain unit. All complications and side effects were also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients participating suffered from primary headaches (migraine, cluster, and tension headache) and occipital neuralgia were enrolled in the study. They have all received in the past the standard systemic pharmacotherapy prophylaxis for headache management (with topiramate or amitriptylline) as well as tryptanes for rescue treatment, and were scheduled for a diagnostic nerve block of the occipital nerves in cases of intractable pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* not adequate response to systemic pharmacotherapy\n* pain over crises of \\>4/10\n* occipital tenderness bilaterally or unilaterally,\n* days with headache of more than 10/month.\n\nExclusion Criteria:\n\n* age\\<18 years old,\n* pregnancy or lactation\n* presence of cardiac pacemaker\n* previous therapy with PRF\n* severe psychiatric disorder\n* severe coagulopathy\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT04339335', 'briefTitle': 'Pulsed Radiofrequency in Chronic Headaches', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Pulsed Radiofrequency of the Occipital Nerves for Chronic Headache Management.', 'orgStudyIdInfo': {'id': 'AttikonH PRF STUDY'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulsed radiofrequency of the occipital nerves', 'type': 'PROCEDURE', 'description': 'pulsed radiofrequency of the greater and lesser occipital nerves bilaterally'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Chrysanthi Batistaki, MD, PhD', 'role': 'CONTACT', 'email': 'chrysabatistaki@yahoo.gr', 'phone': '0030 210 5832371'}], 'facility': '2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'CHRYSANTHI BATISTAKI, MD, PhD', 'role': 'CONTACT', 'email': 'chrysabatistaki@yahoo.gr', 'phone': '00302105832371'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anaesthesiology', 'investigatorFullName': 'Chrysanthi Batistaki', 'investigatorAffiliation': 'Attikon Hospital'}}}}