Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT06532318
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-24', 'releaseDate': '2025-09-06'}], 'estimatedResultsFirstSubmitDate': '2025-09-06'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D052582', 'term': 'Trigger Finger Disorder'}], 'ancestors': [{'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'All participants will have the same assessment and have blood drawn for CBC. Opaque tape masking of the syringes will be done so that care giver and patients are not aware of interventional drug given.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'symptom resolution post injection', 'timeFrame': '3 months', 'description': 'reduction of pain using VAS and absence snapping of finger'}], 'secondaryOutcomes': [{'measure': 'Hand grip strength', 'timeFrame': '3 month', 'description': 'measured grip using hand dynamomter'}, {'measure': 'Q- DASH score', 'timeFrame': '3month', 'description': '11-item self reported disability questionnaire that consider upper extremity as one functional unit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:\n\nDoes platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.\n\nParticipants will:\n\nTake platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.\n\nNo previous treatment for the affected finger.\n\nExclusion Criteria:\n\n* Previous steroid injection\n* Previous Surgery to that finger\n* Thrombocytopenic patients\n* Hand and finger contracture\n* Rheumatoid arthritis of the finger'}, 'identificationModule': {'nctId': 'NCT06532318', 'briefTitle': 'Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Obafemi Awolowo University Teaching Hospital'}, 'officialTitle': 'Comparative Study Between Intralesional Injection of Platelet Rich Plasma and Intralesional Steroid for the Treatment of Trigger Finger in Black Patients', 'orgStudyIdInfo': {'id': 'ERC/2024/06/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients here will have one milliliter of freshly prepared autologus platelet rich plasma injection for the treatment of their trigger finger.', 'interventionNames': ['Biological: Platelet rich plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Patients here will have one milliliter(20mg) injection of pfizer Depo-medrol(methylprednisolone acetate) injection for the treatment of their trigger finger.', 'interventionNames': ['Drug: Pfizer Depo-medrol']}], 'interventions': [{'name': 'Platelet rich plasma', 'type': 'BIOLOGICAL', 'description': 'Freshly prepared autologus platelet rich plasma', 'armGroupLabels': ['Group A']}, {'name': 'Pfizer Depo-medrol', 'type': 'DRUG', 'description': 'Methylprednisolone acetate 20mg/ml injection', 'armGroupLabels': ['Group B']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Obafemi Awolowo University Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'orthopaedic surgeon', 'investigatorFullName': 'Olorunfemi Olayiwola', 'investigatorAffiliation': 'Obafemi Awolowo University Teaching Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-09-06', 'type': 'RELEASE'}, {'date': '2025-09-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Olorunfemi Olayiwola, Consultant orthopaedic surgeon, Obafemi Awolowo University Teaching Hospital'}}}}