Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

NARecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

April 30, 2026

Conditions
Bone FractureHumerus FractureSurgery
Interventions
PROCEDURE

Physiotherapy

All participants will be treated with the standardized physiotherapy protocol suggested by Ratajczak et al. 2019. To receive physiotherapy treatment, participants will need to attend a 30-minute session, twice a week, for 12 weeks.

DEVICE

Photobiomodulation

The PBM will be applied with LED devices in the form of a shoulder brace. The applications will occur every day starting 24 hours after the surgical procedure. The shoulder brace from the brand Cosmedical (Mauá, SP, Brazil) contains 70 red LEDs and 70 infrared LEDs. The area corresponding to the fixation plate will not be irradiated (no LEDs will be placed). PBM will be applied every day for 10 minutes using a device containing 318 light-emitting diodes (LEDs), including 159 LEDs at 660 nm (28.5 mW; 12 J/cm2 to 17 J) and 159 LEDs at 850 nm (23 mW; 10 J/cm2 to 14 J).

DEVICE

Simulation of photobiomodulation

The simulation of PBM will use the same LED devices in the form of a shoulder brace but without active light. It will be applied following the same regimen of the Photobiomodulation group.

Trial Locations (1)

03807-230

RECRUITING

ACN Municipal Hospital, São Paulo

All Listed Sponsors
lead

University of Nove de Julho

OTHER