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

Launched by DJO UK LTD · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective LightForce® Therapy Lasers are in reducing pain from shoulder soft tissue issues, specifically conditions like shoulder impingement syndrome and rotator cuff tendinitis. The study will compare the results of using the laser treatment along with standard care, which includes physiotherapy and exercise, against a sham (fake) laser treatment combined with the same standard care. The goal is to see if the real laser treatment provides better pain relief than the sham treatment for those suffering from shoulder pain for over three months.

To participate in this trial, individuals need to be at least 18 years old and have been diagnosed with shoulder soft tissue inflammation due to the specified conditions. They should also have a certain level of pain that can be measured. There are some criteria that would exclude potential participants, such as having certain other health issues or recent shoulder treatments. If eligible, participants can expect to receive treatment and support as part of their usual care while helping researchers gather important data on the safety and effectiveness of this therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient male or female with age ≥18 years old
• • 2. 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.
• • 3. Patient suffering from shoulder soft tissue inflammation due to SAIS/RCT pain for more than 3 months prior to enrollment
• • 4. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
• • 5. Patient able to provide written informed consent
• Exclusion Criteria:
• • 1. 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
• • 2. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
• • 3. Patients who are administered with corticosteroids, should discontinue the treatment at least 2 weeks prior to study treatment start
• • 4. Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
• • 5. Patients who had systemic inflammatory conditions (i.e.rheumatoid arthritis, polymyalgia rheumatica)
• • 6. Patients who underwent intra-articular injection (Ialuronic acid, platelet rich plasma or corticosteroids) in the shoulder in the last 3 months
• • 7. 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)
• • 8. Patients with a prior history of surgical intervention and implantation of a metal implant into the affected shoulder
• • 9. Patients with a diagnosis of active cancer
• • 10. Patients with tattoos covering more than 30% of the area to be treated with LightForce® Therapy Lasers
• • 11. Patients who are mentally or physically incapacitated
• • 12. Patient participating in other clinical study or has completed a clinical study less than 30 days prior to enrollment
• • 13. Patient affected by shoulder soft tissue acute inflammation due to recent sport injury or trauma
• • 14. 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).
• • 15. Patients with other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator