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ClinicalTrials.gov ID

NCT06759935

Lead Sponsor

DJO UK LtdINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

130Estimated

Last Update Posted

Nov 17, 2025Actual

Start Date

Feb 21, 2025Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Dec 2026Estimated

Official Title

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

Brief 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.

Detailed 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.

• Shoulder Pain
• Shoulder Impingement Syndrome
• Rotator Cuff Tendinitis

• Sham Laser therapy
• Laser therapy
• physiotherapy/exercise protocol

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

DJO UK LtdINDUSTRY

Collaborators

Donawa Lifescience Consulting S.r.l.INDUSTRY

g.papiro@gmail.com

fisiolab3@gmail.com

g.torre1@studenti.uniroma4.it