Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-02-03 @ 3:12 AM
Study NCT ID:
NCT01886157
Status:
UNKNOWN
Last Update Posted:
2015-03-18
First Post:
2013-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052582', 'term': 'Trigger Finger Disorder'}, {'id': 'D053682', 'term': 'Tendon Entrapment'}], 'ancestors': [{'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance with splint and hand exercises', 'timeFrame': '1, 2 months', 'description': 'For patients who are assigned to injection and splint group, home exercise and splint compliance will be assessed by patients maintaining a case log.'}], 'primaryOutcomes': [{'measure': 'Stage of finger triggering', 'timeFrame': '1, 2, 4-6, and 12 months', 'description': 'Trigger Finger Stage:\n\n1. Normal\n2. Painful palpable nodule\n3. Triggering = Clicking = Catching\n4. Locking of finger in flexion or extension unlocked by active finger movement\n5. Locking of finger in flexion or extension unlocked by passive finger movement\n6. Locked finger in flexion or extension (Each stage may be painless or painful)'}], 'secondaryOutcomes': [{'measure': 'Failed treatment: surgical intervention required', 'timeFrame': '1,2, 4-6, 12months', 'description': 'Failed treatment OR Successful treatment'}, {'measure': 'Patient rated functional outcome', 'timeFrame': '1, 2, 4-6, 12months', 'description': 'Quick Disabilities of the Arm, Shoulder and Hand questionnaire Patient Specific Functional Scale'}, {'measure': 'Pain', 'timeFrame': '1, 2, 4-6, 12 months', 'description': 'Visual Analog Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['trigger finger', 'orthotic intervention'], 'conditions': ['Trigger Finger', 'Stenosing Tenosynovitis']}, 'referencesModule': {'references': [{'pmid': '18406955', 'type': 'BACKGROUND', 'citation': 'Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.'}, {'pmid': '269967', 'type': 'RESULT', 'citation': 'Strom L. Trigger finger in diabetes. J Med Soc N J. 1977 Nov;74(11):951-4. No abstract available.'}, {'pmid': '19006759', 'type': 'RESULT', 'citation': 'Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.'}, {'pmid': '1538090', 'type': 'RESULT', 'citation': 'Patel MR, Bassini L. Trigger fingers and thumb: when to splint, inject, or operate. J Hand Surg Am. 1992 Jan;17(1):110-3. doi: 10.1016/0363-5023(92)90124-8.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Treatment of trigger finger by corticosteroid injection and splinting is superior to corticosteroid treatment alone.', 'detailedDescription': 'Stenosing tenosynovitis, or more commonly "trigger finger" is a disease that can severely impact a patient\'s quality of life. Its incidence is said to be 28 persons per 100,000 annually. The disease is manifested in one or more fingers by finger locking in flexion or extension, leading to pain, discomfort and at times, loss of function. Patients frequently report having to snap their fingers back in position to alleviate symptoms. The pathophysiology relates to thickening of the flexor tendon sheath, which can impair tendon gliding within it.\n\nAlthough multiple treatment strategies are available, it is not entirely clear which treatment offers the best outcome, especially when the finger has not reached end stage locking. In general, corticosteroid injection into the tendon sheath is offered as the first line of treatment. Splinting alone has also been described as a reliable method treatment. However, Patel and Bassini indicated that steroid injection results in fewer recurrences than splinting alone. Surgery is typically reserved for recurrent triggering, cases refractory to injection, or digits locked in flexion. The effects of steroid injection followed by splinting however have not been reported in a comprehensive fashion. It may be that this form of treatment could result in a synergistic effect, which can offer a treatment modality superior to either injection or splinting alone. The purpose of this research study is to determine whether steroid injection followed by splinting is superior to injection alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trigger finger in one or more trigger fingers, in stages 2 to 5 (inclusive)\n* Adult patient aged over 18 years.\n* No prior treatment (splinting, injection or surgery) to the involved finger OR at least 1 year since last treatment of the involved finger.\n\nExclusion Criteria:\n\n* Exclude Trigger thumbs because they appear to be respond very favorably or unfavorably to treatment3\n* Exclude locked digits because surgery is indicated in these cases\n* Pregnant patients\n* Prisoners\n* Patients with impaired decision-making capacity\n* Patients that do not speak English and cannot fill in English language questionnaires.'}, 'identificationModule': {'nctId': 'NCT01886157', 'briefTitle': 'Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting', 'organization': {'class': 'OTHER', 'fullName': 'The Philadelphia & South Jersey Hand Center'}, 'officialTitle': 'Treatment of Trigger Finger With Steroid Injection Versus Steroid Injection and Splinting: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11C.554'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid injection', 'description': 'Standard corticosteroid injection.', 'interventionNames': ['Procedure: Corticosteroid injection']}, {'type': 'EXPERIMENTAL', 'label': 'Corticosteroid Injection and Trigger Splint', 'description': 'Corticosteroid Injection + Trigger Splint + Education + Home Exercises', 'interventionNames': ['Procedure: Corticosteroid injection + Trigger Splint+ Education and Home exercises']}], 'interventions': [{'name': 'Corticosteroid injection + Trigger Splint+ Education and Home exercises', 'type': 'PROCEDURE', 'description': 'Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.', 'armGroupLabels': ['Corticosteroid Injection and Trigger Splint']}, {'name': 'Corticosteroid injection', 'type': 'PROCEDURE', 'description': 'Standard trigger finger corticosteroid injection.', 'armGroupLabels': ['Corticosteroid injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Philadelphia and South Jersey Hand Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sidney Jacoby, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Philadelphia and South Jersey Hand Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Philadelphia & South Jersey Hand Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sidney M. Jacoby', 'investigatorAffiliation': 'The Philadelphia & South Jersey Hand Center'}}}}