Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

Surgery Clinical Trial

Official title: Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study

Status Not yet recruiting

Clinical Trial Summary

This double-blind, randomized controlled clinical study aims to evaluate the effects of PBM on the functional recovery of participants with surgically treated PHF using special locking plates. The 42 participants will be randomized (1:1) into two groups: the Control group (standard physical therapy combined with simulated PBM) and the PBM group (standard physical therapy combined with active PBM). Participants will apply PBM at home daily for 10 minutes using a device containing 318 light-emitting diodes (LEDs), with 159 LEDs at 660 nm (28.5 mW; 12 J/cm2; 17 J per LED) and 159 LEDs at 850 nm (23 mW; 10 J/cm2; 14 J per LED). PBM and physical therapy sessions (30 minutes, twice a week) will be conducted over 12 weeks. Participants will be unaware of their group allocation and will be assessed at 24 hours, 1, 2, 4, 8, and 12 weeks after surgery by four examiners who are also blinded to each participant's allocation. The primary outcome, assessed at all time points, 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 using the SF-6 questionnaire, and the occurrence of adverse effects at all time points. Spontaneous pain, pressure pain (measured with a dolorimeter), nighttime pain, and analgesic use will be evaluated at 1, 2, 4, 8, and 12 weeks. Fracture consolidation will be assessed at 4, 8, and 12 weeks through radiographic examinations, and muscle strength will be evaluated by progressive dumbbell support at 8 and 12 weeks. In addition to the scheduled assessments, participants will be contacted daily by phone.

Clinical Trial Description

Among the various complications in the postoperative course of proximal humerus fractures (PHF), pain and joint stiffness are common, leading to significant functional limitations in the affected limb. Physical therapy is the standard treatment for functional recovery, both for surgical and non-surgical cases. Studies have shown positive effects of photobiomodulation (PBM) on fracture repair, regeneration, pain relief, and functional improvement. However, there is a need for standardization and additional evidence. This double-blind, randomized controlled clinical study aims to evaluate the effects of PBM on the functional recovery of participants with surgically treated PHF using special locking plates. The 42 participants will be randomized (1:1) into two groups: the Control group (standard physical therapy combined with simulated PBM) and the PBM group (standard physical therapy combined with active PBM). Participants will apply PBM at home daily for 10 minutes using a device containing 318 light-emitting diodes (LEDs), with 159 LEDs at 660 nm (28.5 mW; 12 J/cm2; 17 J per LED) and 159 LEDs at 850 nm (23 mW; 10 J/cm2; 14 J per LED). PBM and physical therapy sessions (30 minutes, twice a week) will be conducted over 12 weeks. Participants will be unaware of their group allocation and will be assessed at 24 hours, 1, 2, 4, 8, and 12 weeks after surgery by four examiners who are also blinded to each participant's allocation. The primary outcome, assessed at all time points, 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 using the SF-6 questionnaire, and the occurrence of adverse effects at all time points. Spontaneous pain, pressure pain (measured with a dolorimeter), nighttime pain, and analgesic use will be evaluated at 1, 2, 4, 8, and 12 weeks. Fracture consolidation will be assessed at 4, 8, and 12 weeks through radiographic examinations, and muscle strength will be evaluated by progressive dumbbell support at 8 and 12 weeks. In addition to the scheduled assessments, participants will be contacted daily by phone. Collected data will be stored, and organized in a repository, and appropriate statistical tests will be applied for each specific analysis. In all tests, a significance level of 5% will be adopted. ;

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone
• Humeral Fractures
• Humerus Fracture
• Surgery

• NCT number: NCT06113614
• Study type: Interventional
• Source: University of Nove de Julho
• Contact: Kristianne PS Fernandes, PhD
• Phone: +55 11 3385-9241
• Email: kristianneporta@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Completion date: April 30, 2026