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Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
Sponsor: University of Nove de Julho
Summary
Among the various complications of the postoperative evolution of proximal humerus fractures (PHF) are pain and joint stiffness, generating significant functional limitation in the affected limb. This randomized controlled double-blind clinical study aims to evaluate the effects of photobiomodulation (PBM) on the functional recovery of participants with PHF surgically treated with special locking plates. The primary outcome, to be assessed at 1, 2, 4, 8, and 12 weeks, will be shoulder function recovery using the Quick-DASH functional scale. Secondary outcomes will include shoulder range of motion assessments with a digital goniometer, quality of life measured using the SF-6 questionnaire, and the occurrence of adverse effects during all experimental periods. Pain will be evaluated at 1, 2, 4, 8, and 12 weeks; fracture consolidation will be assessed through radiographic examinations at 4, 8, and 12 weeks; and muscular strength will be evaluated through progressive weight-bearing exercises at 8 and 12 weeks. Data will be presented as means ± SD, with significance set at a p-value of 0.05.
Official title: Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2024-04-30
Completion Date
2026-04-30
Last Updated
2024-11-19
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
ACN Municipal Hospital
São Paulo, Brazil