RecruitingNot Applicable

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

Brazil42 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quick-DASH functional scale - 2 weeks

Timeframe: up to 2 weeks

Trial details

NCT IDNCT07426926

SponsorUniversity of Nove de Julho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

Contact for this trial

Kristianne PS Fernandes, PhD

+551133859287 Kristianne Porta <kristianneporta@gmail.com>

View on ClinicalTrials.gov More Distal Radius Fracture trials