Condition: Bone Fracture · Humerus Fracture · Surgery · Sponsor: University of Nove de Julho
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.
This description comes directly from the study's public registry record.
Kristianne PS Fernandes, PhD · +55 11 3385-9241 · kristianneporta@gmail.com
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| ACN Municipal Hospital | São Paulo, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06113614