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Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis - Trial NCT04002037

Access comprehensive clinical trial information for NCT04002037 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Missouri-Columbia and is currently Recruiting. The study focuses on Trigger Finger. Target enrollment is 200 participants.

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NCT04002037
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04002037
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Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial

Study Focus

Trigger Finger

Triamcinolone Acetonide 40mg/mL

Interventional

drug

Sponsor & Location

University of Missouri-Columbia

Columbia, United States of America

Timeline & Enrollment

Phase 4

Jun 25, 2019

Jun 15, 2025

200 participants

Primary Outcome

Green classification of trigger finger severity,Green classification of trigger finger severity,Green classification of trigger finger severity,Disabilities of the Arm, Shoulder and Hand (DASH),Disabilities of the Arm, Shoulder and Hand (DASH),Disabilities of the Arm, Shoulder and Hand (DASH),Pain Visual Analog Score (VAS),Pain Visual Analog Score (VAS),Pain Visual Analog Score (VAS),Upper Extremity Scores (PROMIS),Upper Extremity Scores (PROMIS),Upper Extremity Scores (PROMIS)

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).

ICD-10 Classifications

Trigger finger
Accessory finger(s)
Fused fingers
Accessory thumb(s)
Clubbing of fingers

Data Source

ClinicalTrials.gov

NCT04002037

Non-Device Trial