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RECRUITING
NCT06854016
NA

Performance and Safety of LightForce® Therapy Lasers on Lateral Ankle Sprain

Sponsor: DJO UK Ltd

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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.

OTHER

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