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Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Nove de Julho
NCT07426926 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
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.
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What it tests

  • Open reduction and internal fixation (ORIF) with locked volar plate
  • Home exercises
  • Active photobiomodulation
  • Inactive photobiomodulation
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Where

1 site
ACN Municipal Hospital
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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