Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT04023695
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2019-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic
Sponsor:
Organization:
Raw JSON
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The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.\n\nCorticosteroid with normal saline: Trigger finger injection', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Outcome: Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Corticosteroid With Lidocaine With Epinephrine', 'description': 'This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine\n\nCorticosteroid with lidocaine with epinephrine: Trigger finger injection'}, {'id': 'OG001', 'title': 'Corticosteroid With Normal Saline', 'description': 'This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.\n\nCorticosteroid with normal saline: Trigger finger injection'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed 1 minute after injection (in clinic)', 'description': 'Assessed using the visual analog scale (0-10 scale). 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The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.\n\nCorticosteroid with normal saline: Trigger finger injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed after 24 hours after injection (by phone)', 'description': 'Assessed using the visual analog scale (0-10 scale). 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The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.\n\nCorticosteroid with normal saline: Trigger finger injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Corticosteroid With Lidocaine With Epinephrine', 'description': 'This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine\n\nCorticosteroid with lidocaine with epinephrine: Trigger finger injection'}, {'id': 'BG001', 'title': 'Corticosteroid With Normal Saline', 'description': 'This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.\n\nCorticosteroid with normal saline: Trigger finger injection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'BG000', 'lowerLimit': '39', 'upperLimit': '84'}, {'value': '66', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '84'}, {'value': '64.3', 'groupId': 'BG002', 'lowerLimit': '35', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-27', 'size': 556731, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-28T16:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-07-01', 'resultsFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-30', 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Outcome: Visual Analog Scale', 'timeFrame': 'Assessed 1 minute after injection (in clinic)', 'description': 'Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever'}, {'measure': 'Pain Outcome: Visual Analog Scale', 'timeFrame': 'Assessed after 24 hours after injection (by phone)', 'description': 'Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger']}, 'descriptionModule': {'briefSummary': 'Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.', 'detailedDescription': 'The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old with trigger finger\n\nExclusion Criteria:\n\n* Preference for open trigger finger release\n* Not a candidate for corticosteroid injection\n* Contraindication to lidocaine with epinephrine'}, 'identificationModule': {'nctId': 'NCT04023695', 'briefTitle': 'Trigger Finger Corticosteroid Injection With and Without Local Anesthetic', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial', 'orgStudyIdInfo': {'id': '1064521-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid with lidocaine with epinephrine', 'description': 'This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine', 'interventionNames': ['Drug: Corticosteroid with lidocaine with epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Corticosteroid with normal saline', 'description': 'This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.', 'interventionNames': ['Drug: Corticosteroid with normal saline']}], 'interventions': [{'name': 'Corticosteroid with lidocaine with epinephrine', 'type': 'DRUG', 'description': 'Trigger finger injection', 'armGroupLabels': ['Corticosteroid with lidocaine with epinephrine']}, {'name': 'Corticosteroid with normal saline', 'type': 'DRUG', 'description': 'Trigger finger injection', 'armGroupLabels': ['Corticosteroid with normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Department of Plastic Surgery', 'investigatorFullName': 'Brian Drolet', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}