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

Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures: A Double-Blind, Randomized, Controlled Clinical Trial

This test will see if a home-use light therapy device plus twice-daily home exercises helps adults 18–65 recover wrist function after surgical repair of a distal radius fracture.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Nove de Julho (Academic / other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT07426926 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–65 with isolated, closed distal radius fractures that meet surgical instability criteria and are treated with ORIF using a locked volar plate are ideal candidates.

Not a fit: Patients outside the age range, with open or pathological fractures, prior wrist injuries or neurological deficits, photosensitivity, pregnancy, or other exclusion conditions are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If effective, the intervention could speed functional recovery and reduce pain and stiffness after surgical fixation of distal radius fractures.

How similar studies have performed: Some smaller trials and case series of photobiomodulation for musculoskeletal and postoperative rehabilitation have reported modest benefits for pain and function, but results are mixed and evidence specific to distal radius fractures is limited.

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.

Where this trial is running

São Paulo

• ACN Municipal Hospital — São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Kristianne PS Fernandes, PhD

Conditions Distal Radius Fracture; photobiomodulation; distal radius; locked volar plate; early mobility