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.
This clinical investigation is a post-market, International, multi center, prospective, randomized, sham controlled, single blind study to assess the effectiveness of LightForce® Therapy Lasers and to collect PMCF data on the safety and performance of LightForce® Therapy Lasers, when used in accordance with its approved labeling, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
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 + 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
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
Pain change
Pain reduction measured with Visual Analog Scale (VAS) (0-100 mm) after 6 weeks of treatment compared to pre-treatment (baseline) VAS
Time frame: 6 weeks after treatment start
Safety - adverse event rate
Proportion of patient experiencing an adverse event associated with device use
Time frame: through study completion, an average of 12 weeks
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