Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-12 @ 1:36 AM
Study NCT ID:
NCT01950793
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2013-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of 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': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D006820', 'term': 'Hyaluronic Acid'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-02', 'studyFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2013-09-24', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quinnell classification', 'timeFrame': 'Pre-injection; 3-weeks and 3-months post-injections', 'description': 'he Quinnell system grades trigger fingers as:\n\n0 - normal movement\n\n1. \\- uneven movement\n2. \\- locking can be corrected with active motion\n3. \\- locking corrected with passive motion\n4. \\- unable to correct deformity'}], 'secondaryOutcomes': [{'measure': 'hand functional evaluation', 'timeFrame': 'Pre-injection; 3-weeks and 3-months post-injections', 'description': 'using the Michigan Hand Outcome Questionnaire (MHQ)'}, {'measure': 'visual analog scale', 'timeFrame': 'Pre-injection; 3-weeks and 3-months post-injections'}, {'measure': 'total active motion (TAM)', 'timeFrame': 'Pre-injection; 3-weeks and 3-months post-injections', 'description': 'Defi ned as the total ROM achieved when all three joints-metacarpophalangeal (MCP), proximal interphalangeal (PIP) and distal interphalangeal (DIP) of a digit are actively fl exed or extended simultaneously, minus any extension defi cit at any of the three joints'}, {'measure': 'grip strength', 'timeFrame': 'Pre-injection; 3-weeks and 3-months post-injections', 'description': 'dynamometer strength test (JAMAR grip)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hyaluronic acid, trigger finger'], 'conditions': ['Trigger Finger']}, 'referencesModule': {'references': [{'pmid': '26340807', 'type': 'DERIVED', 'citation': 'Liu DH, Tsai MW, Lin SH, Chou CL, Chiu JW, Chiang CC, Kao CL. Ultrasound-Guided Hyaluronic Acid Injections for Trigger Finger: A Double-Blinded, Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Dec;96(12):2120-7. doi: 10.1016/j.apmr.2015.08.421. Epub 2015 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The study is to compare the effect between steroid injection and Hyaluronic acid in treatment trigger finger. Using sonoguided injection technique achieves more accurate injection location and therapeutic effect. We hypothesize hyaluronic acid has both lubricant and anti-inflammation effect in treatment of trigger finger, and can provide better outcome and lower adverse effect than steroid injection.', 'detailedDescription': 'This is a prospective, randomized, double-blinded controlled study. Patients with the diagnosis of trigger finger will be recruited and enrolled from Taipei Veteran General Hospital PM\\&R outpatient clinic. Subjects will be randomized into two groups; hyaluronic acid and triamcinolone acetonide injections, both via ultrasound-guided with one injection only.We hypothesize that through the anti-inflammatory property of the hyaluronate acid, the treatment effects will be as effective as the traditionally used steroid injections with equal or even lower recurrence rate for treatment of trigger finger. We expect that injections of hyaluronate into tendon sheath could become a new treatment option for trigger finger.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with trigger digits and patients\n* without previous treatment of the trigger digit\n\nExclusion Criteria:\n\n* patients with prior treatment of the trigger digit (eg, splinting, injection, or therapy),\n* patients less than\n* 20 years old,\n* patients with allergy or contraindication to hyaluronic acid,\n* patients with trigger digits due to rheumatoid arthritis,\n* and patients with infection at the site of injection.'}, 'identificationModule': {'nctId': 'NCT01950793', 'briefTitle': 'A Comparison Between Sonoguided Injection Corticosteroid and Hyaluronic Acid Injection in Treatment of Trigger Finger', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'Steroid Versus Hyaluronic Acid Ultrasound-guided Injection for Trigger Finger: A Comparative Study of Outcomes', 'orgStudyIdInfo': {'id': '2012-11-001A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'steroid', 'description': 'used ultrasound-guided inject 1c.c triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)into the sheath of the flexor tendons, penetrated to the A1 pulley.\n\nOne injection only', 'interventionNames': ['Drug: triamcinolone acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid', 'description': 'used ultrasound-guided inject 1c.c Hyaluronic acid (Artz®, Seikagaku, Japan)into the sheath of the flexor tendons, penetrated to the A1 pulley.\n\nOne injection only', 'interventionNames': ['Drug: Hyaluronic Acid']}], 'interventions': [{'name': 'triamcinolone acetonide', 'type': 'DRUG', 'otherNames': ['triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)'], 'description': 'used ultrasound-guided inject 1c.c triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)into the sheath of the flexor tendons, penetrated to the A1 pulley.\n\nOne injection only Steroid', 'armGroupLabels': ['steroid']}, {'name': 'Hyaluronic Acid', 'type': 'DRUG', 'otherNames': ['Hyaluronic acid (Artz®, Seikagaku, Japan)'], 'description': 'used ultrasound-guided inject 1c.c Hyaluronic acid (Artz®, Seikagaku, Japan)into the sheath of the flexor tendons, penetrated to the A1 pulley.\n\nOne injection only', 'armGroupLabels': ['Hyaluronic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chung-Lan Kao, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}