42
Participants
Start Date
April 30, 2024
Primary Completion Date
December 30, 2025
Study Completion Date
April 30, 2026
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.
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).
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.
RECRUITING
ACN Municipal Hospital, São Paulo
University of Nove de Julho
OTHER