Topical Treatment Is Effective and Safe for Acute Ankle Sprains: The Multi-Center Double-Blind Randomized Placebo-Controlled TRAUMED Trial.

ABSTRACT:

Background

Topical NSAIDs are widely used to treat ankle sprains. Traumed (Tr14) gel is a multicomponent formulation, demonstrating inflammation-resolution properties.

Methods

This multicenter, double-blind trial investigated the efficacy and safety of Tr14 gel versus placebo gel and non-inferiority versus 1% diclofenac gel, applied 3×/day for 7 days after acute lateral ankle sprain (EudraCT Number: 2016-004792-50). The primary outcome was AUC for pain on passive movement, assessed by VAS from baseline to Days 4 and 7.

Results

The trial population included 625 patients aged 18 to 78 years. The AUC scores were 187.88 and 200.75 on Day 4 (p = 0.02) and 294.14 and 353.42 on Day 7 (p < 0.001) for Tr14 and placebo, respectively. For Tr14 compared to diclofena

SUBMITTER: Gerdesmeyer L 

PROVIDER: S-EPMC10856131 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature