Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT03583151
Status:
UNKNOWN
Last Update Posted:
2018-07-11
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053682', 'term': 'Tendon Entrapment'}], 'ancestors': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient reported pain level', 'timeFrame': '12 months', 'description': 'Analog pain scale (0-10)'}], 'secondaryOutcomes': [{'measure': 'Trigger frequency', 'timeFrame': '12 months', 'description': "Rate at which a patient's digit will lock or trigger"}, {'measure': 'Disabilities of the Arm Shoulder and Hand score', 'timeFrame': '12 months', 'description': 'Measure of disability in performing every day activities at work and around the house. Calculated value from DASH questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corticosteroid'], 'conditions': ['Stenosing Tenosynovitis']}, 'descriptionModule': {'briefSummary': 'The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Patient is diagnosed with stenosing tenosynovitis\n\nExclusion Criteria:\n\n* Patient is less than 18 years of age\n* Pregnancy\n* Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.'}, 'identificationModule': {'nctId': 'NCT03583151', 'briefTitle': 'Corticosteroid vs. Amniotic Fluid Injections in Patients With Trigger Finger', 'organization': {'class': 'INDUSTRY', 'fullName': 'J&M Shuler'}, 'officialTitle': 'Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial', 'orgStudyIdInfo': {'id': 'Random TF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid injection', 'description': '1 mL Solu-medrol mixed with 0.5mL marcaine and 0.5 mL of lidocaine', 'interventionNames': ['Biological: Steroid injection']}, {'type': 'EXPERIMENTAL', 'label': 'Amniotic fluid injection', 'description': '1 mL amniotic fluid mixed with 0.5mL marcaine and 0.5 mL of lidocaine', 'interventionNames': ['Biological: Amniotic fluid injection']}], 'interventions': [{'name': 'Amniotic fluid injection', 'type': 'BIOLOGICAL', 'description': 'Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair.', 'armGroupLabels': ['Amniotic fluid injection']}, {'name': 'Steroid injection', 'type': 'BIOLOGICAL', 'description': 'Solu-medrol', 'armGroupLabels': ['Steroid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30606', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Athens Orthopedic Clinic', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Michael Shuler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athens Orthopedic Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'J&M Shuler', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vivex Biomedical', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}