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Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis

NCT04002037 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-06-26

Study results available
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Summary

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).

Conditions

  • Trigger Finger

Interventions

DRUG

Triamcinolone Acetonide 40mg/mL

Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

DRUG

Triamcinolone Acetonide 10mg/mL

Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

DRUG

Dexamethasone 4 mg/ml

Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Daniel London, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2022-05-19
Completion
2023-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04002037 on ClinicalTrials.gov