Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 6:37 PM
Study NCT ID:
NCT06137404
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-01
First Post:
2023-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2023-10-29', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': '12 weeks', 'description': 'The VAS is a patient rated outcome measure that enables the patient to rate the intensity of pain from 0 (no pain) to 10 (worse pain that can possibly be)'}], 'primaryOutcomes': [{'measure': "Green's classification for trigger finger", 'timeFrame': '12 weeks', 'description': "Green's classification is an objective outcome measure. The therapist grades the triggering by observing the finger when the patient makes a full fist.\n\nGrade I: Pain/history of catching Grade II: Demonstrable catching but can actively extend digit Grade III: Demonstrable locking, requiring passive extension Grade IV: Fixed flexion contracture\n\nLowest score is I; highest score is IV"}], 'secondaryOutcomes': [{'measure': 'QuickDASH (Disability of Arm, Shoulder and Hand)', 'timeFrame': '12 weeks', 'description': "The QuickDASH is a patient rated questionnaire that rates patient's ability to perform certain tasks as well as severity of symptoms. The best score is 0 (no difficulty) and the lowest score is 100 (severe difficulty)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to evaluate the effectiveness of two splint designs in conservative management of trigger finger.', 'detailedDescription': 'This study aims to analyse and compare the effectiveness of metacarpophalangeal joint blocking splint versus relative motion extension splint for trigger finger. This will help us find out which one of the two splint designs is more effective in the management of trigger finger, thus improving treatment outcomes for patients with trigger finger.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trigger finger patient\n\nExclusion Criteria:\n\n* Diabetes, non-English speaking'}, 'identificationModule': {'nctId': 'NCT06137404', 'briefTitle': 'A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger', 'organization': {'class': 'OTHER', 'fullName': 'Waikato Hospital'}, 'officialTitle': 'A Comparison of Metacarpophalangeal Joint Blocking Splint With Relative Motion Extension Splint for Trigger Finger', 'orgStudyIdInfo': {'id': 'WaikatoH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Splint M', 'description': 'Metacarpophalangeal joint blocking splint', 'interventionNames': ['Other: Splint']}, {'type': 'EXPERIMENTAL', 'label': 'Splint R', 'description': 'Relative motion extension splint', 'interventionNames': ['Other: Splint']}], 'interventions': [{'name': 'Splint', 'type': 'OTHER', 'description': 'Comparison of splints for trigger finger', 'armGroupLabels': ['Splint M', 'Splint R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3204', 'city': 'Hamilton', 'state': 'Waikato Region', 'country': 'New Zealand', 'facility': 'Waikato Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}], 'overallOfficials': [{'name': 'Aarti Parekh, B.Physio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Waikato Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Waikato Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}