Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07426926

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

Led by University of Nove de Julho · Updated on 2026-02-23

42

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 610 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

ACN Municipal Hospital

São Paulo, Brazil, 03807-230

Actively Recruiting

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Research Team

K

Kristianne PS Fernandes, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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