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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All GendersPhase Not Applicable
8 locations
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Actively Recruiting

Researchers are evaluating the effectiveness of LightForce Therapy Lasers in reducing pain for people with shoulder soft tissue inflammation caused by Subacromial Impingement Syndrome SAIS or Rotator Cuff Tendinopathy RCT. This post-market, international, multi-center, prospective, randomized, sham-controlled, single-blind study also gathers safety and performance data for LightForce Therapy Lasers used according to their approved medical device regulations. Participants will receive either the active LightForce Therapy Laser treatment or a sham laser therapy, both combined with a standard physiotherapy and exercise program that includes Codmans pendulum exercises, range of motion, stretching, and isometric strengthening exercises. These interventions are delivered over 4 consecutive weeks, with at least 3 sessions per week. The study compares pain reduction between the two groups and monitors safety throughout. During the study, participants will be assessed for changes in pain 4 weeks after treatment start using visual analog scale VAS scores. Safety is tracked by recording any adverse events throughout an average 21-week period. Participants will follow the prescribed exercise and therapy sessions, and researchers will monitor performance and any side effects of the laser therapy to better understand its impact on shoulder soft tissue inflammation pain.

Age: 18Years +All GendersPhase Not Applicable
10 locations