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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 30, 2026 → Jul 30, 2027
See other at-risk trials from University of Nove de Julho

Record History

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  1. Primary completion pushed from Jul 30, 2026 to Jul 30, 2027 Show 4 more changesShow less
    • Start date: Jul 1, 2025 to Sep 6, 2025
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 29 of 29 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07426926
Lead Sponsor University of Nove de Julho
Conditions
(from sponsor)		 Distal Radius Fracture
Related terms Wrist Fractures
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov