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RECRUITING
NCT06759935
NA

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

Sponsor: DJO UK Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2025-02-21

Completion Date

2026-12

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DEVICE

Sham Laser therapy

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

DEVICE

Laser therapy

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

OTHER

physiotherapy/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.

Locations (10)

Cabinet Attal

Serris, France

Fisioterapia Carioni

Cassano d'Adda, Milano, Italy

Casertafisio

Caserta, Italy

Rachis Center

Roma, Italy

Fisiolab3

Roma, Italy

Fisioterapia Eur

Roma, Italy

Fisioterapia Gardenie

Roma, Italy

Freedom Care Clinics

Leeds, United Kingdom

Indergaard Physiotherapy Ltd

Leeds, United Kingdom

Freedom Care Clinic

Manchester, United Kingdom