Home-use photobiomodulation (light) therapy to help recovery after distal radius (wrist) fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized controlled trial enrolling 42 adults who undergo open reduction and internal fixation of isolated distal radius fractures with a locked volar plate. Participants are randomized 1:1 to use either an active photobiomodulation (PBM) LED device or an inactive (placebo) device at home, alongside an unsupervised twice-daily home exercise program beginning 24 hours after surgery and continuing for 12 weeks. The PBM device is applied once daily to the wrist for 12 minutes (6 minutes dorsal, 6 minutes palmar) and the control device is visually identical but inactive. The primary outcome is functional wrist recovery measured by the QuickDASH questionnaire, with additional clinical measures collected during follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• ACN Municipal Hospital
  São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Kristianne PS Fernandes, PhD
• Email: Kristianne Porta <kristianneporta@gmail.com>
• Phone: +551133859287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.