Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-28 @ 8:57 AM
Study NCT ID:
NCT04645303
Status:
UNKNOWN
Last Update Posted:
2020-11-27
First Post:
2020-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injection of Hyaluronic Acid Versus Corticosteroid for 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': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-06-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-25', 'studyFirstSubmitDate': '2020-11-04', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quinnell trigger finger grading system:', 'timeFrame': '1 and 3 months post-injection', 'description': 'Change in Quinnell grading overtime within 3 months after injection. Trigger fingers are rated as follows: Grade 0: normal finger movements, Grade 1: uneven finger movements, Grade 2: actively correctable triggering, Grade 3: passively correctable triggering, and Grade 4: locked digit.'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale (VAS) of pain', 'timeFrame': '1 and 3 months post-injection', 'description': 'Change in pain Visual analogue scale will be recorded. The patient marks on the 100 mm in length line the point that he/she feels to represent his/her perception of pain at the current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks ( a higher score indicates greater pain intensity). Categorization of none, mild, moderate and severe pain will be also used (none = 0, mild = 1-4, moderate = 5-6, and severe = 7-10).'}, {'measure': 'Frequency of tender trigger nodules', 'timeFrame': '1 and 3 months post-injection', 'description': 'Identifying the presence of tender nodules at A1-pulley of the affected finger by palpation'}, {'measure': 'The Quick Disability of the Arm, Shoulder and Hand score', 'timeFrame': '1 and 3 months post-injection', 'description': 'Patients will be asked to fill a questionnaire form. It is an 11-item form that assesses the upper limb function on a scale of 1-5, with scores ranging from 11 to 55, with the higher scores representing more disability and worse upper limb function.'}, {'measure': 'Changes in Grip strength', 'timeFrame': '1 and 3 months post-injection', 'description': 'Measured by the dynamometer strength test (Jamar grip dynamometer)'}, {'measure': 'Patient satisfaction with therapy', 'timeFrame': '1 and 3 months post-injection', 'description': 'Participating patients will be asked to classify their result into 1 of 4 categories: (1) complete resolution of symptoms, (2) improved result, but incomplete resolution of symptoms, not warranting further treatment, (3) partial response, but unsatisfactory, warranting further treatment, and (4) no response.'}, {'measure': 'Ultrasound evaluation of A1-Pulley', 'timeFrame': '1 and 3 months post-injection', 'description': 'Detailed ultrasonography evaluation of A1-Pulley. Comparing the A1-Pulley ultrasonographic parameters over 3 months after injection (at the follow-up appointment)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigger finger', 'Hyaluronic Acid', 'Corticosteroid', 'Ultrasound-guided injection'], 'conditions': ['Trigger Finger']}, 'referencesModule': {'references': [{'pmid': '26340807', 'type': 'BACKGROUND', '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.'}, {'pmid': '21545190', 'type': 'BACKGROUND', 'citation': 'Callegari L, Spano E, Bini A, Valli F, Genovese E, Fugazzola C. Ultrasound-guided injection of a corticosteroid and hyaluronic acid: a potential new approach to the treatment of trigger finger. Drugs R D. 2011;11(2):137-45. doi: 10.2165/11591220-000000000-00000.'}, {'pmid': '24895610', 'type': 'BACKGROUND', 'citation': 'Abate M, Schiavone C, Salini V. The use of hyaluronic acid after tendon surgery and in tendinopathies. Biomed Res Int. 2014;2014:783632. doi: 10.1155/2014/783632. Epub 2014 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the therapeutic effects of hyaluronic acid versus steroid injections in treating trigger fingers using ultrasound guidance', 'detailedDescription': 'A prospective randomized controlled study designed to compare the outcomes of injecting patients with trigger finger with hyaluronic acid versus corticosteroid under ultrasound guidance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult (\\>18 years)\n* Patients with a clinical diagnosis of trigger finger grade 1-3 on the Quinnell grading scale and confirmed diagnosis by ultrasound.\n\nExclusion Criteria:\n\n* Quinnell's classification grade IV (contracture)\n* Prior injection within 6 months\n* Prior operation of the affected finger\n* Presence of any contracture in the proximal interphalangeal or metacarpophalangeal joint, and\n* History of diabetes, hypothyroidism, and\n* Rheumatic or connective tissue disease\n* Allergy to triamcinolone or hyaluronic acid\n* Pregnancy\n* Secondary triggering e.g. Trauma, infection\n* Trigger finger symptoms duration \\>6 months"}, 'identificationModule': {'nctId': 'NCT04645303', 'briefTitle': 'Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dubai Health Authority'}, 'officialTitle': 'Ultrasound-Guided Injection of Hyaluronic Acid Versus Corticosteroid for Treatment of Trigger Finger: Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'DSREC-12/2019_03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyaluronic acid', 'description': '1mL of hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1-pulley.', 'interventionNames': ['Drug: hyaluronic acid (20 mg/2 mL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone acetonide', 'description': '1 mL of Triamcinolone acetonide 10mg/ml infiltration at A1-Pulley under ultrasound guidance after subcutaneous 2% lidocaine without epinephrine infiltration of the skin overlying the A1 pulley.', 'interventionNames': ['Drug: Triamcinolone acetonide 10mg/ml']}], 'interventions': [{'name': 'hyaluronic acid (20 mg/2 mL)', 'type': 'DRUG', 'otherNames': ['Hyalgan 20 mg in 2 ML Prefilled Syringe'], 'description': 'A1-Pulley infiltration for trigger finger', 'armGroupLabels': ['Hyaluronic acid']}, {'name': 'Triamcinolone acetonide 10mg/ml', 'type': 'DRUG', 'otherNames': ['Kenalog 10 mg/ml'], 'description': 'A1-Pulley infiltration for trigger finger', 'armGroupLabels': ['Triamcinolone acetonide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dubai', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'role': 'CONTACT', 'email': 'mmabdulla@dha.gov.ae', 'phone': '442195718', 'phoneExt': '00971'}, {'name': 'Sahar Khalil, SSR', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed Abdulla', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dubai Hospital- Dubai Health Authority', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'centralContacts': [{'name': 'Sahar S Khalil, SSR', 'role': 'CONTACT', 'email': 'sskhalil@dha.gov.ae', 'phone': '00971557557453'}, {'name': 'Mohamed M Abdulla, Consultant', 'role': 'CONTACT', 'email': 'mmabdulla@dha.gov.ae', 'phone': '00971506584352'}], 'overallOfficials': [{'name': 'Sahar S Khalil, SSR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Specialist Senior Registrar- Physical Medicine and rehabilitation Department- Dubai hospital'}, {'name': 'Mohamed M Abdulla, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'Consultant and Head of Physical Medicine and rehabilitation Department- Dubai hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dubai Health Authority', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist Senior Registrar- Physical Medicine and Rehabilitation Department- Dubai Hospital- UAE( co-affiliation: Assistant Professor Rheumatology, physical Medicine and rehabilitation- Zagazig University- Egypt)', 'investigatorFullName': 'Sahar Said Khalil', 'investigatorAffiliation': 'Dubai Health Authority'}}}}