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

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.

Distal radius fracture (DRF) is one of the most common fractures in adults. Its treatment can be either conservative or surgical; however, regardless of the treatment method, it is often associated with pain, loss of function and grip strength, joint stiffness, prolonged absence from work, and even loss of fracture reduction. 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 (1:1 ratio). 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 LED plate will contain 100 light-emitting diodes, distributed as follows: 18 LEDs at 630 nm (23 mW; 117 J/cm²; 8 J per LED); 18 LEDs at 680 nm (20 mW; 102 J/cm²; 7 J per LED); 32 LEDs at 760 nm (24 mW; 122 J/cm²; 9 J per LED); and 32 LEDs at 830 nm (28 mW; 143 J/cm²; 10 J per LED). 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 two 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. Participants will be blinded to their group allocation and will be evaluated by four researchers who are also blinded to the allocation. 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. In addition to these scheduled assessments, each participant will be followed up with daily phone contact. All collected data will be stored and organized in a secure repository, and appropriate statistical tests will be applied for each specific analysis. A significance level of 5% will be adopted for all tests.

Inclusion criteria:

• Adults aged 18 to 65 years,
• Both sexes,
• Patients with isolated, closed distal radius fractures with displacement and surgical indication,
• Surgical indication defined by instability criteria:
• Dorsal tilt of the distal fragment >20°,
• Radial shortening ≥10 mm,
• Articular incongruity,
• Dorsal comminution,
• Fractures classified as Fernandez types I, II, or III,
• Fractures classified as AO/OTA types 2R3A2, 2R3A3, 2R3B, or 2R3C (except 2R3C3).

Exclusion criteria:

• Previous wrist injuries, sequelae, or motor deficits due to neurological lesions,
• Pathological fractures,
• Ipsilateral fractures in other regions of the limb,
• Neurovascular injury with sensory deficit at the fracture site,
• Local or systemic contraindications to surgery or postoperative recovery,
• History of photosensitivity,
• Neurological and/or psychiatric disorders,
• Proliferative or infectious skin lesions at the wrist region,
• Pregnancy,
• Surgical complications (neurological or vascular injuries, or fracture line extension) - excluded from analysis but reported.