Clinical Research Directory

Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain

DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy/exercise program, compared to sham laser combined with standard of care (RICE and physiotherapy/exercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. In addition, this study allows to collect post market clinical data on the safety and performance of LightForce® Therapy Lasers, when used, following the normal clinical practice, in accordance with its approved and CE marked intended use.

First-degree Ankle Sprains

Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Treatment often involves conservative methods, including the PRICEMMS protocol (protection, rest, ice, compression, elevation, modalities, medication, and support), while surgery is reserved for severe cases. Therapeutic exercises and rehabilitation play a key role in recovery. The Bowen technique, effective for other musculoskeletal issues, has not yet been extensively studied for Grade I ankle sprains.