Actively Recruiting
Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
Led by University of Nove de Julho · Updated on 2024-11-19
42
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Among the various complications of the postoperative evolution of proximal humerus fractures (PHF) are pain and joint stiffness, generating significant functional limitation in the affected limb. This randomized controlled double-blind clinical study aims to evaluate the effects of photobiomodulation (PBM) on the functional recovery of participants with PHF surgically treated with special locking plates. The primary outcome, to be assessed at 1, 2, 4, 8, and 12 weeks, will be shoulder function recovery using the Quick-DASH functional scale. Secondary outcomes will include shoulder range of motion assessments with a digital goniometer, quality of life measured using the SF-6 questionnaire, and the occurrence of adverse effects during all experimental periods. Pain will be evaluated at 1, 2, 4, 8, and 12 weeks; fracture consolidation will be assessed through radiographic examinations at 4, 8, and 12 weeks; and muscular strength will be evaluated through progressive weight-bearing exercises at 8 and 12 weeks. Data will be presented as means ± SD, with significance set at a p-value of 0.05.
CONDITIONS
Official Title
Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Both genders
- Isolated and closed proximal humerus fractures with displacement
- Surgical indication for open reduction and internal fixation with locking plate
- Fractures classified as Neer group III, IV, or V
- Fractures classified as AO/OTA subgroups A2 and A3, group B
- AO/OTA group C fractures allowed only for patients under 55 years old
You will not qualify if you...
- Pre-existing injuries or lasting problems in the shoulder or shoulder girdle
- Motor deficits caused by central or peripheral neurological injuries
- Pathological fractures
- Postoperative infection or implant loosening
- Fractures in other parts of the same limb on the same side
- Neurovascular injuries causing sensory loss at the injury site
- Conditions that contraindicate surgery or complicate recovery
- History of photosensitivity
- Neurological or psychiatric disorders
- Proliferative or infectious skin lesions in the shoulder area where LED light is applied
- Use of anti-inflammatory drugs within five days before the trauma
- Pregnancy
- Surgical complications such as neurological or vascular injuries or fracture extension during surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
ACN Municipal Hospital
São Paulo, Brazil, 03807-230
Actively Recruiting
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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