Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT00203294
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kathleen.Bradley@Jefferson.edu', 'phone': '215-955-2025', 'title': 'Kathleen Bradley', 'organization': 'Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'GON Block Only', 'description': 'Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GON Block Plus Steroid', 'description': 'Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine 2% and Bupivacaine 0.25% Plus Saline', 'description': 'Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections'}, {'id': 'OG001', 'title': 'Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg.', 'description': 'Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.29', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '1.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.', 'groupDescription': "Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "Fisher's exact test was used to compare nominal variables between groups.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 15 patients in group A (no steroids injected) and 14 in group B (steroids injected).'}, {'type': 'PRIMARY', 'title': 'Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.', 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'unitOfMeasure': 'pain unit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.', 'timeFrame': '20 minutes', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.', 'timeFrame': '20 minutes', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GON Block Only', 'description': 'Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.'}, {'id': 'FG001', 'title': 'GON Block Plus Steroid', 'description': 'Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GON Block Only', 'description': 'Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.'}, {'id': 'BG001', 'title': 'GON Block Plus Steroid', 'description': 'Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-07', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2011-05-19', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-07', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache Severity as Measured on an 11-point Verbal Scale (0 to 10):0=No Pain 10=Excruciating Pain', 'timeFrame': '20 minutes', 'description': 'Headache severity was assessed on an 11-point verbal scale twenty minutes after treatment'}, {'measure': 'Decrease in Headache Pain, as Measured on an 11-point Pain Scale (0=no Pain, 10=Excruciating Pain). Change in Headache Pain 20 Minutes After Injection Will be Compared Between Treatment Groups.', 'timeFrame': '20 minutes'}], 'secondaryOutcomes': [{'measure': 'To Evaluate the Effect of Treatment on Neck Pain in the Two Groups Compared to Historical Baseline, and Between the Two Treatment Groups.', 'timeFrame': '20 minutes'}, {'measure': 'To Evaluate Effect of Treatment on Associated Symptoms (Nausea, Phonophobia and Photophobia) as Measured Using a 4 Point Scale (None, Mild, Moderate, Severe) Compared to Historical Baseline, and Between the Two Treatment Groups.', 'timeFrame': '20 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital nerve. The nerve runs superficially in this area, therefore the drugs are injected just under the skin. The injected drugs block electrical transmission through the nerve, resulting in reduced head pain. There are treatment options for patients receiving a GONB, however, some clinicians use local anesthetics (lidocaine and /or bupivicaine) alone, and some use local anesthetics with local steroid injection. The purpose of this study is to evaluate whether or not there is an observed difference between these two treatment approaches for GONB. We expect to enroll 60 patients into this research study at Thomas Jefferson University only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, age 18-65 inclusive\n* Patients who have chronic daily headache (15 or more headache days per month) for at least 3 months prior to enrollment in the study.\n* Headache level should be 5/10 or more at time of GON block.\n* Patients should have posterior cervical muscle tenderness at time of nerve block.\n\nExclusion Criteria:\n\n* Patients who had surgery or any other invasive procedure in the occipital area.\n* Patients with abnormal sensory findings on examination or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).\n* Patients diagnosed with cluster headache\n* Patients with skin diseases that may affect skin sensation.\n* Patients who are cognitively impaired.\n* Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.\n* Patients who are pregnant or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT00203294', 'briefTitle': 'A Research Study to Examine the Difference Between Local Anesthetics Alone and Local Anesthetics Plus Steroids in the Treatment of Chronic Headache', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Comparison Of Greater Occipital Nerve Block With Lidocaine And Bupivicaine Alone Or With Steroids In a Chronic Headache Population', 'orgStudyIdInfo': {'id': 'GONB/ STE/ 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine 2%, Bupivicaine 0.5% and saline', 'description': 'Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.', 'interventionNames': ['Drug: lidocaine, bupivicaine and saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg', 'description': 'Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally.', 'interventionNames': ['Drug: lidocaine plus bupivicaine plus triamcinolone (steroid)']}], 'interventions': [{'name': 'lidocaine, bupivicaine and saline', 'type': 'DRUG', 'description': 'lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.', 'armGroupLabels': ['Lidocaine 2%, Bupivicaine 0.5% and saline']}, {'name': 'lidocaine plus bupivicaine plus triamcinolone (steroid)', 'type': 'DRUG', 'otherNames': ['Kenalog'], 'description': 'lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.', 'armGroupLabels': ['Lidocaine 2%, Bupivicaine 0.5% and triamcinolone 40 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Headache Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Stephen D Silberstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University, Jefferson Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}