Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-01 @ 12:33 PM
Study NCT ID:
NCT06785935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-21
First Post:
2025-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between 2 Treatment Modalities of Trigger Finger: Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2025-01-15', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity using the visual analog scale (VAS) scoring system', 'timeFrame': 'Before the procedure as well as after one week, one month, and three months'}, {'measure': 'Functional ability according to the standard quick disabilities of the arm, shoulder, and hand score (Q DASH) questionnaire', 'timeFrame': 'Before the procedure as well as after one week, one month, and three months'}, {'measure': "Recurrence: The grade of trigger finger according to Green's classification", 'timeFrame': 'Before the procedure as well as after one week, one month, and three months'}, {'measure': 'Complications such as inflammation, infection, scarring, wound healing problems, and sensory changes', 'timeFrame': 'After one week of the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trigger Finger']}, 'descriptionModule': {'briefSummary': 'Trigger finger is a common cause of hand disability and pain in the general population. It is a pathologic condition of the digital pulleys and flexor tendons. Although the pathogenesis is incompletely clear and multifactorial, the most common cause of the trigger finger is the thickened flexor tendon and/or thickened first annular (A1) pulley located at the metacarpophalangeal joint. Currently, ultrasound is considered an effective and valuable tool for assessing the trigger finger, providing static and dynamic evaluations of this condition and a comparison with the adjacent normal digits. Recently, it has been reported that ultrasound-guided percutaneous A1 pulley precise release using a needle knife has received increasing attention in the clinical treatment of trigger fingers and achieved good results. To our knowledge, this is the first clinical study comparing the efficacy and safety of ultrasonic-guided percutaneous A1 pulley release with a needle knife and the ultrasonic-guided steroid injection in treating trigger fingers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Idiopathic trigger finger\n* Trigger finger at the level of A1 pulley\n* Trigger finger of Green's grades II or III\n\nExclusion Criteria:\n\n* Patients with secondary causes of trigger fingers like diabetes mellitus, rheumatoid arthritis, gout, hypothyroidism, amyloidosis, and sarcoidosis.\n* Patients with a previous history of first annular pulley release or injection.\n* Patients with trigger fingers of Green's grade I and IV.\n* Patients with trigger fingers at any level other than the A1 pulley."}, 'identificationModule': {'nctId': 'NCT06785935', 'briefTitle': 'Comparison Between 2 Treatment Modalities of Trigger Finger: Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University Hospital'}, 'officialTitle': 'Ultrasound-guided Percutaneous Release of A1 Pulley by a Needle Knife Versus Ultrasound-guided Corticosteroid Injection in the Treatment of Trigger Finger: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'MS.24.10.2929'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife', 'interventionNames': ['Device: Needle knife']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley', 'interventionNames': ['Drug: Corticosteroid: Betamethasone']}], 'interventions': [{'name': 'Needle knife', 'type': 'DEVICE', 'description': 'ultrasonography-guided percutaneous A1 pulley release using a needle knife', 'armGroupLabels': ['Patients undergoing ultrasonography-guided percutaneous A1 pulley release using a needle knife']}, {'name': 'Corticosteroid: Betamethasone', 'type': 'DRUG', 'description': 'ultrasonography-guided corticosteroid injection under the A1 pulley', 'armGroupLabels': ['Patients undergoing ultrasonography-guided corticosteroid injection under the A1 pulley']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University Hospitals', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Rheumatology, rehabilitation, and physical medicine department at Mansoura University Hospitals', 'investigatorFullName': 'Nouran Khalid Ibrahim Sallam', 'investigatorAffiliation': 'Mansoura University Hospital'}}}}