Effects of light therapy on recovery from shoulder fractures
Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
This study is testing whether light therapy can help people recover better from shoulder fractures after surgery compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Nove de Julho Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06113614 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of photobiomodulation (PBM) on the recovery of patients with proximal humerus fractures who have undergone surgical treatment. Participants will be randomly assigned to receive either active PBM combined with standard physiotherapy or a simulated PBM treatment. The study will assess shoulder function recovery using the Quick-DASH scale at multiple time points, alongside secondary outcomes such as range of motion, quality of life, and pain levels. The trial aims to provide evidence on the effectiveness of PBM in enhancing functional recovery post-surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 65 with isolated, closed proximal humerus fractures requiring surgical intervention.
Not a fit: Patients with pre-existing shoulder injuries, neurological deficits, or those who develop postoperative complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes and quality of life for patients with proximal humerus fractures.
How similar studies have performed: Previous studies have suggested positive effects of photobiomodulation on fracture healing, but this specific approach is still being evaluated for its efficacy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- ACN Municipal Hospital — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Kristianne PS Fernandes, PhD — University of Nove de Julho
- Study coordinator: Kristianne PS Fernandes, PhD
- Email: kristianneporta@gmail.com
- Phone: +55 11 3385-9241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.