Study of LightForce Therapy Lasers Combined With Standard Care to Reduce Pain in Adults With Acute Lateral Ankle Sprains

What this Trial Is About

Researchers are evaluating the effectiveness of LightForce4 Therapy Lasers combined with standard care on reducing pain in adults with acute grade I - II lateral ankle sprains. This post-market, multi-center, randomized, single-blind study compares active laser therapy to a sham laser, both alongside the usual RICE protocol and physiotherapyexercise program. The study also collects safety and performance data on the laser device as used in normal clinical practice. Participants will receive either LightForce4 Therapy Lasers or sham laser treatment for 4 consecutive weeks, with at least 3 sessions per week during the first 2 weeks and at least 2 sessions per week for the next 2 weeks. All participants will follow the standard care program including daily RICE at home for 2 weeks and a physiotherapyexercise program with two sessions per week for 4 weeks. The study aims to assess pain reduction and safety outcomes over this period. During the study, participants will be assessed for pain changes 2 weeks after starting treatment and monitored for any adverse events throughout an average follow-up of 12 weeks. Researchers will collect clinical data, including pain scores and safety information, to evaluate the laser therapys performance. The entire participation duration includes treatment and follow-up, ensuring thorough observation of patient response and device safety.

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