RecruitingNot ApplicableNCT06759935

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

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

Sponsor

DJO UK Ltd

Enrollment

130 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Shoulder Pain

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria15

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

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Interventions

DEVICESham Laser therapy

sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.

DEVICELaser therapy

laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.

OTHERphysiotherapy/exercise protocol

physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes Codman's pendulum exercise, range of motion (ROM) exercises, stretching and isometric strengthening exercises, for 4 consecutive weeks with a minimum of 3 sessions per week.