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RCT on the Performance and Safety of LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction (SPARK)
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 subjects with unilateral or bilateral knee osteoarthritis. 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 knee osteoarthritis. 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 Knee Osteoarthritis Pain Reduction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2024-11-23
Completion Date
2026-03-30
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
Laser therapy + physiotherapy/exercise protocol
laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol (program includes kinesitherapy, range of motion (ROM) exercises, stretching, strengthening, and flexibility exercises) for 6 consecutive weeks, for a minimum of 2 sessions per week
Sham Laser therapy + physiotherapy/exercise protocol
sham laser therapy + standard of care (SOC) represented by physiotherapy/exercise protocol (program includes kinesitherapy, range of motion (ROM) exercises, stretching, strengthening, and flexibility exercises) for 6 consecutive weeks, for a minimum of 2 sessions per week
Locations (7)
Cabinet d'Ostéopathie
Grésy-sur-Aix, France
Cabinet Allaire
Le Havre, France
Casertafisio
Caserta, Italy
Fisioterapia Carioni
Milan, Italy
Fisioterapia EUR
Roma, Italy
Fisioterapia Gardenie
Roma, Italy
Indergaard Physiotherapy
Leeds, United Kingdom