Clinical Research Directory
Browse clinical research sites, groups, and studies.
Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain
Sponsor: DJO UK Ltd
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.
Official title: Randomized, Sham Controlled, Single Blind Study on the Performance and Safety of Photo Biomodulation Therapy (PBMT) With LightForce® Therapy Lasers on Lateral Ankle Sprain Pain Reduction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-04-11
Completion Date
2026-09
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Sham Laser therapy
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
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 and physiotherapy/exercise protocol
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.
Locations (8)
Carioni Fisioterapia
Cassano d'Adda, Milano, Italy
Casertafisio
Caserta, Italy
Rachis Center
Roma, Italy
Fisiolab3
Roma, Italy
Fisioterapia Eur
Roma, Italy
Fisioterapia Gardenie
Roma, Italy
INDERGAARD PHYSIOTERAPY Ltd
Leeds, United Kingdom
Freedom Care Clinics
Manchester, United Kingdom