Using LightForce® Therapy Lasers to Reduce Shoulder Pain

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

This study is testing whether LightForce® Therapy Lasers can help reduce shoulder pain from conditions like Subacromial Impingement Syndrome and Rotator Cuff Tendinopathy when used with regular physiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: DJO UK Ltd (Industry-sponsored)
• Locations: 10 sites (Serris and 9 other locations)
• Trial ID: NCT06759935 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of LightForce® Therapy Lasers in reducing pain associated with shoulder soft tissue inflammation, specifically targeting conditions like Subacromial Impingement Syndrome and Rotator Cuff Tendinopathy. Participants will receive either the laser therapy combined with standard physiotherapy or a sham laser treatment alongside physiotherapy. The study is designed as a randomized, sham-controlled, single-blind investigation to ensure unbiased results while also collecting safety and performance data for the lasers in a real-world clinical setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of shoulder soft tissue inflammation due to SAIS or RCT, experiencing pain for more than three months.

Not a fit: Patients with contraindications to laser therapy or those currently taking medications that may interfere with the treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate shoulder pain and improve the quality of life for patients suffering from shoulder soft tissue inflammation.

How similar studies have performed: Previous studies have shown promising results with laser therapy for pain reduction, indicating potential success for this approach.

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

Where this trial is running

Serris and 9 other locations

• Cabinet Attal — Serris, France (Completed)
• Fisioterapia Carioni — Cassano d'Adda, Milano, Italy (Recruiting)
• Casertafisio — Caserta, Italy (Recruiting)
• Rachis Center — Roma, Italy (Recruiting)
• Fisiolab3 — Roma, Italy (Recruiting)
• Fisioterapia Eur — Roma, Italy (Recruiting)
• Fisioterapia Gardenie — Roma, Italy (Recruiting)
• Freedom Care Clinics — Leeds, United Kingdom (Recruiting)
• Indergaard Physiotherapy Ltd — Leeds, United Kingdom (Completed)
• Freedom Care Clinic — Manchester, United Kingdom (Recruiting)

Study contacts

• Principal investigator: ANDREA TURIACO, Physiotherapist — Fisioterapia Gardenie
• Study coordinator: Elena Arcangeli

Conditions Shoulder Pain; Shoulder Impingement Syndrome; Rotator Cuff Tendinitis