Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Re… (NCT06759935) | Clinical Trial Compass
RecruitingNot Applicable
Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
France, Italy130 participantsStarted 2025-02-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to its intended use and indications
✕. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
✕. Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start
✕. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
✕. Patients who had systemic inflammatory conditions (i.e.rheumatoid arthritis, polymyalgia rheumatica)
✕. Patients who underwent intra-articular injection (Ialuronic acid, platelet rich plasma or corticosteroids) in the shoulder in the last 3 months
✕. Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)
✕. Patients with a prior history of surgical intervention and implantation of a metal implant into the affected shoulder