Serris

This research aims to confirm the safety and performance of several Chattanooga Intelect4 devices in real-world use for patients with musculoskeletal and skeletal muscle disorders. The study is a post-market, international, multi-center, prospective observational investigation designed to comply with European Medical Device Regulation requirements. It focuses on patients treated according to current clinical practice to ensure ongoing benefit-risk acceptability and to detect any misuse or off-label use of the devices. Participants will be treated with various Intelect4 devices, including those providing TENS, ultrasound US, and neuromuscular electrical stimulation NMES. Two groups are studied one with acute or chronic musculoskeletal or post-operative pain treated with TENS alone, US alone, or both and another with skeletal muscle deficits treated with NMES alone or combined with US. Treatments follow standard clinical practice at each site. The study observes treatment effects over about 6 weeks, with further follow-up to about 12 weeks. During the study, participants will undergo evaluations including pain reduction, muscle reeducation, range of motion improvement, and overall clinical status. Safety is monitored by recording adverse events throughout the average 15-week study period. Data collection relies on routine clinical assessments, and participants provide informed consent. The study helps characterize how these devices perform and are used in everyday clinical settings over time.

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.