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
- Distal Radius Fracture
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- University of Nove de Julho
- Enrolment target
- 42
- Started
- 6 September 2025
- Main results due
- 30 July 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
ACN Municipal Hospital
São Paulo, Brazil
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07426926. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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