Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDJO UK Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Pregnant females or females of childbearing potentially planning to become pregnant during the study participation
Trial design
Treatments tested in this trial
- Sham Laser therapy
- Laser therapy
- RICE and physiotherapy/exercise protocol
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
DJO UK Ltd
Lead sponsor
Donawa Lifescience Consulting SRL
Collaborator
Source ClinicalTrials.gov