Clinical trial

Investigating Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections Using Betamethasone and Methylprednisolone

Name
2103263450
Description
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
Trial arms
Trial start
2021-09-15
Estimated PCD
2022-12-27
Trial end
2023-04-10
Status
Completed
Phase
Early phase I
Treatment
Betamethasone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
Arms:
Betamethasone
Methylprednisolone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Arms:
Methylprednisolone
Size
66
Primary endpoint
Incidence of Pain
Up to 7 days
Intensity of Pain
Up to 7 days
Incidence of Flare Reaction
From baseline up to 7 days
Eligibility criteria
Inclusion Criteria: * Single trigger injection * First time for the digit * No prior surgery on digit Exclusion Criteria: * Current oral steroid use * Rheumatoid arthritis * More than one single digit involved * Previous injection in same digit * Prior surgery on same digit * Other injections in the same clinic on the same day
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2023-06-23

1 organization

2 products

1 indication

Indication
Trigger Finger