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Search / Trial NCT06113614

Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

Launched by UNIVERSITY OF NOVE DE JULHO · Oct 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Photobiomodulation

ClinConnect Summary

This clinical trial is studying how a treatment called photobiomodulation (PBM) can help people recover after surgery for a specific type of arm fracture known as proximal humerus fractures. The goal is to see if using light therapy can improve shoulder function, reduce pain, and enhance overall quality of life for patients who have had these fractures treated with special locking plates. Participants will be evaluated at several points over 12 weeks to measure their shoulder movement, pain levels, and strength, as well as to check how well their bone is healing through imaging tests.

To participate in this study, individuals should be between 18 and 55 years old and have certain types of displaced proximal humeral fractures that require surgical treatment. However, those with previous shoulder injuries, infections, or other specific health conditions may not be eligible. If you decide to join, you can expect regular assessments and support throughout the recovery process, all while contributing to research that could help improve treatment for future patients with similar injuries.

Gender

ALL

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.

About University Of Nove De Julho

The University of Nove de Julho (UNINOVE) is a prestigious educational institution located in São Paulo, Brazil, renowned for its commitment to advancing research and innovation in the field of health sciences. As a clinical trial sponsor, UNINOVE aims to foster collaboration between academia and the healthcare industry, facilitating the development and evaluation of novel therapeutic interventions. With a robust infrastructure and a team of experienced researchers, the university is dedicated to conducting high-quality clinical trials that adhere to rigorous ethical standards and regulatory guidelines, ultimately contributing to improved health outcomes and the enhancement of medical knowledge.

Locations

Sao Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Kristianne PS Fernandes, PhD

Principal Investigator

University of Nove de Julho

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported