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drugset / Trial / NCT04002037

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

NCT04002037 ↗

Phase 4 Terminated 95 enrolled University of Missouri-Columbia
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2019-06-25
Primary completion
2022-05-19
Completion
2023-01-01

Publications

  • Background 1- Wolfe SW, Hotchkiss RN, Pederson WC, Kozin SH, Tendinopathy, in: Green's Operative Hand Surgery, 6th edition, Churchill Livingstone, Chap. 62, p. 5, 2011.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 4 mg/ml Other
Comparator Triamcinolone Acetonide Other / unclassified 10 mg/ml Other
Comparator Triamcinolone Acetonide Other / unclassified 40 mg/ml Other

Indications

No indication recorded.