Actively Recruiting
Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
Led by University of Nove de Julho · Updated on 2024-11-19
42
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how photobiomodulation (PBM) affects recovery after surgery for proximal humerus fractures (PHF). These fractures can cause pain and stiffness, limiting arm function. The study is a double-blind, randomized controlled trial comparing standard physiotherapy alone to physiotherapy combined with PBM. The main goal is to see how shoulder function improves over 12 weeks using the Quick-DASH scale, with other measures including range of motion, quality of life, pain levels, fracture healing, and muscle strength. Participants will be randomly assigned to one of two groups. One group receives standard physiotherapy twice weekly for 30 minutes plus daily PBM treatment at home using a shoulder brace with 318 LEDs emitting red and infrared light. The other group receives the same physiotherapy and a simulated PBM device without active light. Both treatments last for 12 weeks starting 24 hours after surgery. The study is double-blinded so neither participants nor examiners know the group assignments. During the study, participants will have shoulder function assessed at 1, 2, 4, 8, and 12 weeks after surgery. Range of motion and pain will be measured regularly, and fracture healing will be checked by X-rays at 4, 8, and 12 weeks. Muscle strength will be tested at 8 and 12 weeks. Researchers will also monitor any adverse effects throughout the 12-week period. Data will be analyzed to understand PBM's impact on recovery after proximal humerus fracture surgery.
CONDITIONS
Brief Title
Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 65 years
- Both genders
- Isolated and closed proximal humerus fractures with displacement
- Surgical indication for open reduction and internal fixation with a locking plate
- Fracture classifications: Neer groups III, IV, V; AO/OTA subgroups A2, A3, B; AO/OTA group C (only if under 55 years old)
You will not qualify if you...
- Pre-existing shoulder or shoulder girdle injuries or motor deficits from neurological injuries
- Pathological fractures
- Postoperative infection or implant loosening
- Ipsilateral fractures in other limb regions
- Neurovascular injuries causing sensory deficits at injury site
- Local or systemic conditions contraindicating surgery or complicating recovery
- History of photosensitivity
- Neurological or psychiatric disorders
- Proliferative or infectious skin lesions in the shoulder region
- Use of anti-inflammatory drugs within five days before trauma
- Pregnancy
- Surgical complications such as neurological or vascular injuries or fracture line extension during surgery
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 - 12 weeks
Participants receive surgical treatment for proximal humerus fractures followed by standardized physiotherapy sessions twice a week for 12 weeks and daily photobiomodulation or simulated photobiomodulation at home for 10 minutes each day.
Physiotherapy sessions twice a week and daily photobiomodulation or simulated photobiomodulation at home
Duration - 12 weeks
Participants are monitored with assessments of shoulder function, range of motion, pain levels, muscle strength, fracture healing, quality of life, and adverse events after surgery during the 12-week treatment period.
Assessments at 1, 2, 4, 8, and 12 weeks after 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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