Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain (NCT06854016) | Clinical Trial Compass
RecruitingNot Applicable
Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
Italy108 participantsStarted 2025-04-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient male or female with age ≥18 years old
✓. Patient with diagnosis of LAS (as confirmed by physical examination) to be treated by LightForce® Therapy Lasers according to its indications.
✓. Patient suffering from LAS pain for no more than 72 hours prior to enrollment
✓. Pain (either persistent or during activities) score reported by the subject at baseline ≥ 40 mm measured on VAS
✓. Patient able to provide written informed consent
Exclusion criteria
✕. Patient with musculoskeletal pathological conditions not to be treated with/contraindication to the use of LightForce® Therapy Lasers according to its intended use and indications
✕. Patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids
✕. Patients who have been administered with corticosteroids after injury
✕. Patients who have a disease that would limit their participation in exercises (i.e. severe chronic obstructive pulmonary disease, severe heart failure, cerebrovascular event history)