Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial

2014039

Trigger finger is a common cause of hand pain and dysfunction. Its due to chronic inflammation of the flexor tendon that leads to a pulley system mismatch. Historically it has been managed either conservatively with corticosteroid injections or through a surgical release of the A1 pulley. Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. The purpose of out study is to determine if a 0.5 cc injection of Triamcinolone 40 mg/mL will be the most effective steroid injection for the non-surgical treatment. Approximately 200 subjects will be enrolled and randomized to one of three treatment arms: Triamcinolone 40mg/mL, Triamcinolone 10mg/mL and Soluble dexamethasone 4mg/mL. Treatment success will be defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months).

2019-06-25

2022-05-19

2023-01-01

Terminated

Early phase I

120

Inclusion Criteria: 1. Adults aged 18 years and older 2. At least one symptomatic trigger finger 3. Patients recommended to receive corticosteroid injections Exclusion Criteria: 1. Previous surgeries/injections for trigger fingers in digit being treated for study 2. Participating in another clinical trial 3. Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.) 4. Unable to sign informed consent 5. Pregnant or plan to become pregnant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}

2023-10-05