Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in shoulder soft tissue inflammation. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by physiotherapy/exercise program compared to sham laser combined with standard of care (physiotherapy/exercise program) on pain reduction in subjects with shoulder soft tissue inflammation due to Impingement (Subacromial impingement syndrome (SAIS)) or Rotator Cuff Tendinopathy (RCT),. 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.
• Patient male or female with age ≥18 years old
• Patient with diagnosis of shoulder soft tissue inflammation due to SAIS/RCT (as confirmed by physical examination and/or imaging) to be treated by LightForce® Therapy Lasers according to its indications.
• Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain for more than 3 months prior to enrollment
• Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
• Patient able to provide written informed consent