Actively Recruiting
Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures: A Double-Blind, Randomized, Controlled Clinical Trial
Led by University of Nove de Julho · Updated on 2026-02-23
42
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Distal radius fractures (DRFs) are common injuries in adults that often lead to pain, reduced wrist function, grip strength loss, and joint stiffness. This trial investigates whether adding home-based photobiomodulation (PBM) therapy to standard surgical treatment and home exercises can improve recovery after surgery. The study is a double-blind, randomized controlled trial involving 42 adults aged 18 to 65 years with surgically indicated DRFs. Participants are randomly assigned to one of two groups. Both groups receive the standard surgical procedure called open reduction and internal fixation with a locked volar plate, and both begin home exercises 24 hours after surgery, performed twice daily for 12 weeks. The PBM group uses an active wrist device with 100 LEDs delivering light therapy once daily for 12 minutes, while the control group uses an inactive device that looks and sounds the same but does not emit therapeutic light. Participants will be assessed at 24 hours, and then at 2, 4, 6, and 12 weeks after surgery. Evaluations include wrist function using the QuickDASH questionnaire, pain and disability measured with the PRWE-BR instrument, wrist range of motion, grip strength, and fracture healing. Daily phone follow-ups and blinded assessments ensure data quality. The main focus is on wrist function two weeks after surgery, with ongoing monitoring of other recovery aspects.
CONDITIONS
Brief Title
Home-Based Photobiomodulation Effects in the Postoperative Period of Distal Radius Fractures
Who Can Participate
Eligibility Criteria
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 such as dorsal tilt of the distal fragment greater than 20 degrees
- Radial shortening of 10 mm or more
- 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)
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 such as neurological or vascular injuries, or fracture line extension (excluded from analysis but reported)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo open reduction and internal fixation (ORIF) with a locked volar plate to treat the distal radius fracture without postoperative immobilization.
1 visit (in-person)
Duration - 12 weeks
Participants perform a home exercise program twice daily for 12 weeks and use a photobiomodulation device (active or inactive) once daily for 12 minutes on the wrist as part of their rehabilitation.
Daily phone contact and scheduled assessments at 24 hours, 2, 4, 6, and 12 weeks post-surgery
Duration - Up to 12 weeks post-surgery
Participants are evaluated for wrist function, pain, range of motion, grip strength, and fracture healing during scheduled assessments to monitor recovery progress.
Assessments at 24 hours, 2, 4, 6, and 12 weeks post-surgery
Trial Site Locations
Total: 1 location
1
ACN Municipal Hospital
São Paulo, Brazil, 03807-230
Actively Recruiting
Research Team
K
Kristianne PS Fernandes, PhD
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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