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 diclofenac, the AUC scores were 187.50 and 197.19 on Day 4 (p = 0.3804) and 293.85 and 327.93 on Day 7 (p = 0.0017), respectively. On the FAAM-ADL subscale, Tr14 was superior to placebo and non-inferior to diclofenac at all time points. Time to 50% pain improvement was lowest for Tr14 (6.0 days), compared to placebo (7.1 days) and diclofenac (7.0 days). Adverse events were uncommon and minor. CONCLUSIONS: Tr14 gel is effective and safe in acute ankle sprains, compared to placebo gel and diclofenac gel, and has faster pain resolution. TRIAL REGISTRATION The trial was registered in clinicaltrialsregister.eu, EudraCT number 2016-004792-50 on 07.06.2017.