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

DJO UK Ltd

Status: Enrolling

Conditions: Shoulder Pain; Rotator Cuff Tendinitis; Shoulder Impingement Syndrome

Treatments: Device: Laser therapy; Device: Sham Laser therapy; Other: physiotherapy/exercise protocol

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06759935

ENOVIS-S-INP-0010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Sham Laser treatment - Arm 1

Sham Comparator group

Description:

Sham Laser therapy

Treatment:

Other: physiotherapy/exercise protocol

Device: Sham Laser therapy

Laser Treatment - Arm 2

Active Comparator group

Description:

Laser therapy

Treatment:

Other: physiotherapy/exercise protocol

Device: Laser therapy