Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04568993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2020-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The TriggerHappy Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain after injection', 'timeFrame': 'Four weeks', 'description': 'Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"'}, {'measure': 'Impairment of finger motion', 'timeFrame': 'Four weeks', 'description': 'Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"'}, {'measure': 'Triggering', 'timeFrame': 'Four weeks', 'description': 'Visual analouge scale (VAS), range 0-10, where 0 indicates "no trigger phenomenon" and 10 "Trigger phenomenon all the time/ locked finger"'}], 'secondaryOutcomes': [{'measure': 'Quick-DASH', 'timeFrame': 'Four weeks', 'description': 'generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger', 'Trigger Thumb', 'Minimally Invasive Surgery']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.', 'detailedDescription': 'This study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. The patient assess: 1. Pain 2. Motion and 3. Triggering by VAS scale every day for four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:•\n\n1. Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion\n2. Localized tenderness volar to the MCP joint of the affected finger\n3. The patient seeks treatment\n\nExclusion Criteria:\n\n1. Previous treatment for triggerfinger in the finger to be treated\n2. Impaired function of finger due to previous trauma/infection or other condition\n3. Suspicion of other cause than triggeriinger/tendovaginitis\n4. Patient not able to follow instructions'}, 'identificationModule': {'nctId': 'NCT04568993', 'acronym': 'Triggerhappy', 'briefTitle': 'The TriggerHappy Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Patient-reported Outcome After Corticoid Injection for Triggerfinger- a Randomized Controlled Study Between Two Injection Procedures and Between Corticoid Injection and Percutaneous Release', 'orgStudyIdInfo': {'id': 'The TriggerHappy Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'proximal phalangeal level', 'description': 'injection in the the tendon sheet over proximal phalanx of finger', 'interventionNames': ['Procedure: Proximal phalangeal level']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'volar MCP level', 'description': 'injection above the A1 pulley volar to the MCP joint', 'interventionNames': ['Drug: Volar to the MCP-joint']}], 'interventions': [{'name': 'Proximal phalangeal level', 'type': 'PROCEDURE', 'description': 'Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx', 'armGroupLabels': ['proximal phalangeal level']}, {'name': 'Volar to the MCP-joint', 'type': 'DRUG', 'description': 'Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint', 'armGroupLabels': ['volar MCP level']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alingsås', 'country': 'Sweden', 'facility': 'Alingsås Lasarett/ District Hospital', 'geoPoint': {'lat': 57.93033, 'lon': 12.53345}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultant surgeon, MD, PhD', 'investigatorFullName': 'Joakim Stromberg', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}