Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT03847935
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2019-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trigger Finger Treatment
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': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009788', 'term': 'Occupational Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2019-02-08', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional use using Quick DASH 6 weeks', 'timeFrame': 'Day 1, 6 weeks', 'description': 'Change from baseline to 6 weeks Quick DASH'}, {'measure': 'Change in Functional use using Quick DASH 3 months', 'timeFrame': 'Day 1, 3 months', 'description': 'Change from baseline to 3 months Quick DASH'}, {'measure': 'Change in Functional use using Quick DASH 6 months', 'timeFrame': 'Day 1, 6 months', 'description': 'Change from baseline to 6 months Quick DASH'}, {'measure': 'Change in Edema 6 weeks', 'timeFrame': 'day 1, 6 weeks', 'description': 'Baseline to 6 weeks Circumferential measurement in centimeters of the proximal phalanx'}, {'measure': 'Change in Edema 3 months', 'timeFrame': 'day 1, 3 months', 'description': 'Baseline to 3 months weeks Circumferential measurement in centimeters of the proximal phalanx'}, {'measure': 'Change in Edema 6 months', 'timeFrame': 'day 1, 6 months', 'description': 'Baseline to 6 months weeks Circumferential measurement in centimeters of the proximal phalanx'}, {'measure': 'Change in Pain on a likert scale 6 weeks', 'timeFrame': '1 day, 6 weeks', 'description': 'Baseline to 6 weeks pain on a 0-10 scale'}, {'measure': 'Change in Pain on a likert scale 3 months', 'timeFrame': '1 day, 3 months', 'description': 'Baseline to 3 months pain on a 0-10 scale'}, {'measure': 'Change in Pain on a likert scale 6 months', 'timeFrame': '1 day, 6 months', 'description': 'Baseline to 6 months pain on a 0-10 scale'}, {'measure': 'Change in Range of motion 6 weeks', 'timeFrame': '1 day, 6 weeks', 'description': 'Baseline to 6 weeks flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.'}, {'measure': 'Change in Range of motion 3 months', 'timeFrame': '1 day, 3 months', 'description': 'Baseline to 3 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.'}, {'measure': 'Change in Range of motion 6 months', 'timeFrame': '1 day, 6 months', 'description': 'Baseline to 6 months flexion and extension range of motion at metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) using a finger goniometer.'}, {'measure': 'Change in Severity or Grade of triggering 6 weeks', 'timeFrame': '1 day, 6 weeks', 'description': 'Baseline to 6 weeks Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion'}, {'measure': 'Change in Severity or Grade of triggering 3 months', 'timeFrame': '1 day, 3 months', 'description': 'Baseline to 3 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion'}, {'measure': 'Change in Severity or Grade of triggering 6 months', 'timeFrame': '1 day, 6 months', 'description': 'Baseline to 6 months Using the scale by Patel and Bassini to measure the amount of triggering 1=normal joint, 6=locked in flexion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment outcome', 'hand therapy', 'physical therapy', 'occupational therapy'], 'conditions': ['Trigger Finger', 'Trigger Digit', 'Stenosing Tenosynovitis']}, 'referencesModule': {'references': [{'pmid': '20825126', 'type': 'BACKGROUND', 'citation': 'Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.'}]}, 'descriptionModule': {'briefSummary': 'Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness and/or snapping during movement. This observational study compared all of the possible treatments and combinations of treatments for trigger finger at the A1 pulley, including surgery, cortisone injections and hand therapy.', 'detailedDescription': 'Trigger finger is a common disorder of the hand which causes pain at the A1 pulley, inflammation, stiffness or snapping during movement. This can be very debilitating. Current treatment includes local steroid injection, oral NSAIDS, resting orthoses, physical or occupational therapy and surgical intervention. The aim of this prospective study with an observational design was to determine the outcome between surgical, hand therapy rehabilitation, and corticosteroid injection interventions for trigger finger. There were 6 treatment groups: surgery, corticosteroid injection, 1 visit of hand therapy for orthosis fabrication and therapeutic exercise, hand therapy in combination with cortisone injection, Modality hand therapy alone (ongoing visits) or with corticosteroid injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing medical treatment or hand therapy for trigger finger in digits #2-5 at the hand clinic. Patients were dropped from the study if they had changed to a different treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* trigger finger in digit 2-5\n\nExclusion Criteria:\n\n* if prior treatment for trigger finger, or Trigger thumb'}, 'identificationModule': {'nctId': 'NCT03847935', 'briefTitle': 'Trigger Finger Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Lowell'}, 'officialTitle': 'Trigger Finger Treatment - An Outcomes Study. Comparing 6 Traditional Treatment Techniques', 'orgStudyIdInfo': {'id': 'H-12583'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery', 'description': 'Patients who underwent surgical release of A1 pulley', 'interventionNames': ['Procedure: surgery']}, {'label': 'corticosteroid injections only', 'description': 'Patients who underwent local corticosteroid injections only, and no other treatment', 'interventionNames': ['Procedure: corticosteroid injections']}, {'label': 'hand therapy only occupational/physical', 'description': '1 visit: orthosis fabrication, range of motion, nodule and ice massage.', 'interventionNames': ['Other: Hand Therapy']}, {'label': 'Injection and Hand therapy', 'description': 'This group of participants received a combination of corticosteroid injection in the affected finger and one visit of hand therapy.', 'interventionNames': ['Procedure: corticosteroid injections', 'Other: Hand Therapy']}, {'label': 'Modality Hand Therapy', 'description': 'Ongoing hand therapy treatment, which included the above plus modalities such as ultrasound or iontophoresis.', 'interventionNames': ['Other: Modality Hand Therapy']}, {'label': 'Injection and Modality Hand Therapy', 'description': 'Ccombination of local cortiscosteroid injection to the affected digit and ongoing hand therapy with modalities.', 'interventionNames': ['Procedure: corticosteroid injections', 'Other: Modality Hand Therapy']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': 'A1 pulley release of finger', 'armGroupLabels': ['Surgery']}, {'name': 'corticosteroid injections', 'type': 'PROCEDURE', 'description': 'corticosteroid injection to A1 pulley', 'armGroupLabels': ['Injection and Hand therapy', 'Injection and Modality Hand Therapy', 'corticosteroid injections only']}, {'name': 'Hand Therapy', 'type': 'OTHER', 'otherNames': ['physical therapy', 'occupational therapy'], 'description': 'orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,', 'armGroupLabels': ['Injection and Hand therapy', 'hand therapy only occupational/physical']}, {'name': 'Modality Hand Therapy', 'type': 'OTHER', 'description': 'orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis', 'armGroupLabels': ['Injection and Modality Hand Therapy', 'Modality Hand Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erika S. Lewis, Ed.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, University of Massachusetts Lowell'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There are no plans for sharing the IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Lowell', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'ELewis', 'investigatorAffiliation': 'University of Massachusetts, Lowell'}}}}