Study Comparing LightForce Therapy Lasers Plus Physiotherapy to Sham Laser Plus Physiotherapy for Reducing Shoulder Soft Tissue Inflammation Pain

What this Trial Is About

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.

Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction