NCT06113614 Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
| NCT ID | NCT06113614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nove de Julho |
| Condition | Bone Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2024-04-30 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
The subjects selected for inclusion will be individuals of both genders treated at HMACN hospital, with isolated and closed proximal humerus fractures with displacement and surgical indication, undergoing open reduction and internal fixation (ORIF) with a locking angular stability plate for the proximal humerus (Neer 1070, Carrera et al., 2012; Petros, 2019), and meeting the following eligibility criteria. Individuals aged between 18 and 65 years, of both genders, with proximal humerus fractures classified as: Neer group III Neer group IV Neer group V AO/OTA subgroups A2 and A3 AO/OTA group B AO/OTA group C (only for patients under 55 years of age) Exclusion criteria: Individuals with pre-existing injuries or sequelae in the shoulder and shoulder girdle or motor deficits due to central or peripheral neurological injuries; Individuals with pathological fractures; Individuals who develop postoperative infection or implant loosening; Individuals with ipsilateral fractures in other regions of the limb; Individuals with neurovascular injuries causing sensory deficits at the injury site; Individuals with local or systemic conditions contraindicating surgical intervention or complicating postoperative recovery; Individuals with a history of photosensitivity; Individuals with neurological or psychiatric disorders; Individuals with proliferative or infectious skin lesions in the shoulder region receive LED light; Individuals who used anti-inflammatory drugs within five days before the trauma; Pregnant women; Individuals with surgical complications such as neurological or vascular injuries or fracture line extension during surgery will not meet the desired evolution pattern.
Contact & Investigator
Kristianne PS Fernandes, PhD
PRINCIPAL INVESTIGATOR
University of Nove de Julho
Frequently Asked Questions
Who can join the NCT06113614 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bone Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06113614 currently recruiting?
Yes, NCT06113614 is actively recruiting participants. Contact the research team at kristianneporta@gmail.com for enrollment information.
Where is the NCT06113614 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06113614 clinical trial?
NCT06113614 is sponsored by University of Nove de Julho. The principal investigator is Kristianne PS Fernandes, PhD at University of Nove de Julho. The trial plans to enroll 42 participants.