Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures
Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures: A Double-Blind, Randomized, Controlled Clinical Trial
University of Nove de Julho
42 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
Summary
This double-blind, randomized controlled clinical trial aims to evaluate the adjuvant effect of home-based photobiomodulation (PBM) therapy on the rehabilitation of surgically treated DRFs combined with an unsupervised home exercise program. A total of 42 participants will be randomly allocated into two groups. The Control Group will undergo the standard surgical procedure, perform the prescribed home exercises recommended by the hospital service, and use an inactive LED plate (photobiomodulation device). The PBM Group will follow the same surgical and exercise protocols but will use an active PBM device. Home exercises will begin 24 hours after surgery and should be performed twice daily for a total of 12 weeks. The device will be applied once daily to the wrist for 12 minutes (6 minutes on the dorsal side and 6 minutes on the palmar side). The primary outcome will be functional wrist assessment using the QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand) questionnaire at 2 weeks. Secondary outcomes will include wrist range of motion, grip strength, wrist function, and pain (assessed using the PRWE-BR instrument), as well as fracture healing. Assessments will be performed at 2, 4, 6, and 12 weeks post-surgery, except for bone consolidation (assessed starting at week 4) and for pain and range of motion, which will also be evaluated at 24 hours.
Eligibility
Plain Language Summary
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Interventions
All participants will undergo open reduction and internal fixation (ORIF) with a locked volar plate, without postoperative immobilization.
Unsupervised protocol twice daily for 12 weeks, starting 24 hours post-surgery
The intervention consists of an active photobiomodulation wrist brace equipped with 100 light-emitting diodes (LEDs), including 18 LEDs at 630 nm delivering 23 mW of power, 117 J/cm², and 8 J per LED; 18 LEDs at 680 nm delivering 20 mW of power, 102 J/cm², and 7 J per LED; 32 LEDs at 760 nm delivering 24 mW of power, 122 J/cm², and 9 J per LED; and 32 LEDs at 830 nm delivering 28 mW of power, 143 J/cm², and 10 J per LED. The device will be applied once daily for a total of 12 minutes, with six minutes directed to the dorsal aspect of the wrist and six minutes to the volar aspect, over a 12-week period.
The intervention consists of an inactive LED wrist plate that is identical in appearance and sound to the active device but contains no active LEDs. It will be applied once daily for 12 minutes, during which the device will emit only activation light and sound, without delivering therapeutic irradiation.
Locations(1)
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NCT07426926