NCT07426926 Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures
| NCT ID | NCT07426926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nove de Julho |
| Condition | Distal Radius Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-07-01 with a primary completion date of 2026-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Kristianne PS Fernandes, PhD
STUDY DIRECTOR
University of Nove de Julho
Frequently Asked Questions
Who can join the NCT07426926 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Distal Radius Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07426926 currently recruiting?
Yes, NCT07426926 is actively recruiting participants. Contact the research team at Kristianne Porta <kristianneporta@gmail.com> for enrollment information.
Where is the NCT07426926 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07426926 clinical trial?
NCT07426926 is sponsored by University of Nove de Julho. The principal investigator is Kristianne PS Fernandes, PhD at University of Nove de Julho. The trial plans to enroll 42 participants.