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

NCT06759935 | Recruiting

• 1 other identifier: ENOVIS-S-INP-0010
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 10

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.

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Rotator Cuff Tendinitis

Outcome Measures

Primary Outcomes (1)

• Pain change

  Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) after 4 weeks of treatment compared to pre-treatment (baseline) VAS

  4 weeks after treatment start

Secondary Outcomes (1)

• Safety - adverse event rate

  through study completion, an average of 21 weeks

Other Outcomes (9)

• Pain change

  1,2,3,6, 9 and 12 weeks

• Shoulder pain and disability

  2, 4, 6 and at 12 weeks

• Patient overall status change

  2, 4, 6 ans 12 weeks after treatment start

Study Arms (2)

Sham Laser treatment - Arm 1

SHAM COMPARATOR

Sham Laser therapy

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

Laser Treatment - Arm 2

ACTIVE COMPARATOR

Laser therapy

Device: Laser therapy; Other: physiotherapy/exercise protocol

Interventions

Sham Laser therapy DEVICE

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

Sham Laser treatment - Arm 1

Laser therapy DEVICE

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

Laser Treatment - Arm 2

physiotherapy/exercise protocol OTHER

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.

Laser Treatment - Arm 2; Sham Laser treatment - Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DJO UK Ltd: lead
• Donawa Lifescience Consulting: collaborator

Study Sites (10)

Cabinet Attal

Serris, France

COMPLETED

Fisioterapia Carioni

Cassano d'Adda, Milano, Italy

RECRUITING

Casertafisio

Caserta, Italy

RECRUITING

Rachis Center

Roma, 00199, 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

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Rotator Cuff Injuries

Interventions

Laser Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Rehabilitation

Study Officials

• ANDREA TURIACO, Physiotherapist

  Fisioterapia Gardenie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Arcangeli

CONTACT

3498772528; elena.arcangeli@enovis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 6, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (3); IT (6)