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

This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers, when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

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
• Patients with a diagnosis of active cancer
• Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
• Patients who are mentally or physically incapacitated
• Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
• Patient affected by shoulder soft tissue acute inflammation due to recent sport injury or trauma
• Patients with other musculoskeletal problems of the shoulder joint such as calcifying tendinitis, full thickness rotator-cuff tear, adhesive capsulitis, fibromyalgia, recent surgery or fracture of the shoulder joint, and/or undergoing to specific physiotherapy for these ("recent" is defined as within 30 days prior to enrollment).
• Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator