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ACTIVE NOT RECRUITING
NCT06654739
NA

RCT on the Performance and Safety of LightForce® Therapy Lasers on Knee Osteoarthritis Pain Reduction (SPARK)

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 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

Interventions

DEVICE

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

DEVICE

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