DJO UK Ltd (ENOVIS) is conducting this study to assess the effectiveness of LightForce® Therapy Lasers on pain reduction in subjects with ankle soft tissue trauma and/or sport injury. In detail this study will assess superiority of LightForce® Therapy Lasers combined with standard of care, represented by RICE and physiotherapy/exercise program, compared to sham laser combined with standard of care (RICE and physiotherapy/exercise program) on pain reduction in subjects with acute grade I - II lateral ankle sprain. 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
108
sham laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
laser therapy for 4 consecutive weeks with a minimum of 3 sessions per week, for the first 2 weeks, and then a minimum of 2 sessions per week for the following 2 weeks.
RICE plus physiotherapy/exercise protocol represents the standard of care (SOC) and the program includes: for the first 2 weeks RICE protocol performed daily at home by the patient, for the following 4 weeks a physiotherapy/exercise protocol will be performed at site with 2 sessions per week.
Carioni Fisioterapia
Cassano d'Adda, Milano, Italy
RECRUITINGCasertafisio
Caserta, Italy
RECRUITINGRachis Center
Roma, Italy
RECRUITINGFisiolab3
Roma, Italy
RECRUITINGFisioterapia Eur
Roma, Italy
RECRUITINGFisioterapia Gardenie
Roma, Italy
RECRUITINGINDERGAARD PHYSIOTERAPY Ltd
Leeds, United Kingdom
COMPLETEDFreedom Care Clinics
Manchester, United Kingdom
RECRUITINGPain change
Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) after 4 weeks of treatment compared to pre-treatment (baseline) VAS
Time frame: 2 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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