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Performance and Safety of LightForce® Therapy Lasers on Shoulder Soft Tissue Inflammation Pain Reduction
Sponsor: DJO UK Ltd
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
Sham Laser therapy
sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.
Laser therapy
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week.
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