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

NARecruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

April 11, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

September 30, 2026

Conditions
Ankle Sprain 1St DegreeAnkle Sprain 2Nd DegreeAcute Pain
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.

Trial Locations (8)

Unknown

RECRUITING

Carioni Fisioterapia, Cassano d'Adda

RECRUITING

Casertafisio, Caserta

RECRUITING

Fisiolab3, Roma

RECRUITING

Fisioterapia Eur, Roma

RECRUITING

Fisioterapia Gardenie, Roma

RECRUITING

INDERGAARD PHYSIOTERAPY Ltd, Leeds

RECRUITING

Freedom Care Clinics, Manchester

00199

RECRUITING

Rachis Center, Roma

All Listed Sponsors
lead

DJO UK Ltd

INDUSTRY