Impacto da fotobiomodulação com dispositivo de led de uso domiciliar na reabilitação de fraturas de úmero proximal: estudo clínico controlado randomizado duplo cego

Abstract

Pain and joint stiffness are frequent complications after proximal humerus fractures (PHF), resulting in important functional limitation. Photobiomodulation (PBM) has shown benefits in fracture rehabilitation. This double-blind, randomized clinical trial evaluated the effects of PBM on the functional recovery of surgically treated PHF. Forty-two participants were randomized (1:1) into a Control group (physiotherapy + simulated PBM) and a PBM group (physiotherapy + active PBM). PBM was applied daily at home for 10 minutes using a device with 318 LEDs (159 LEDs at 660 nm: 28.5 mW, 12 J/cm², 17 J; and 159 LEDs at 850 nm: 23 mW, 10 J/cm², 14 J). PBM and physiotherapy sessions were conducted for 12 weeks. Participants and evaluators remained blinded to allocation, and assessments occurred at 24 h, 1, 2, 4, 8, and 12 weeks after surgery and daily through telephone contact. The primary outcome was shoulder function (QuickDASH). Secondary outcomes included range of motion, muscle strength, pain, analgesic consumption, quality of life (SF-6D), bone consolidation, occurrence of adverse events, and cost-effectiveness. Disability (QuickDASH) decreased over time in both groups, with a more pronounced reduction in the PBM group, although without significant interaction. There were no differences between groups in the evolution of range of motion, except for medial rotation, which showed lower values in the PBM group when comparing weeks 2, 8, and 12 versus day 1, without significant interaction. The PBM group showed fewer days with pain at weeks 8 and 12, with significant group–time interaction. Functional pain intensity showed significant interaction at weeks 4, 8, and 12, with lower intensity in the PBM group at week 12. For nighttime pain, there was significant interaction at week 12, with reduction in the PBM group and increase in the control. Both groups presented a progressive increase in pressure tolerated until the sensation of pain, without differences or significant interaction. Dipyrone consumption (days and tablets) showed significant interaction at weeks 8 and 12, with an increase in the control and lower values in the PBM group; this group also showed a lower mean number of days of dipyrone use. Tramadol use showed no differences or significant interactions. The SF-6D showed significant interactions at weeks 8 and 12, with a trend toward improvement in the PBM group. No differences were observed between groups in bone consolidation or muscle strength, and no adverse events related to PBM were reported. In the cost-effectiveness analysis, PBM demonstrated greater mean effectiveness in reducing QuickDASH scores and days with pain, although associated with incremental cost. PBM proved to be safe and associated with improvements in important clinical parameters, especially in reducing pain and dipyrone consumption between weeks 8 and 12, in addition to a trend toward improved quality of life. Although it did not alter global function, range of motion, muscle strength, or bone consolidation and generated financial increment, its analgesic effects suggest usefulness as an adjuvant to physiotherapy in the postoperative recovery of surgically treated PHF, indicating that PBM incorporation should simultaneously consider clinical gain and cost.