Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

NCT06113614 | Recruiting

• 1 other identifier: 6.075.552
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Fracture; Humerus Fracture; Surgery

Keywords

photobiomodulation

Outcome Measures

Primary Outcomes (5)

• Quick-DASH functional scale

  In this project, the dysfunction and symptom component of the QuickDASH score, validated for Brazil and available online, will be used. The QuickDASH score is calculated as follows: At least 10 out of the 11 items must be answered. Each answered question will have a maximum value of 5. These values are then transformed into a score of 100 by subtracting 1 and multiplying by 25. This transformation is done to compare the scores with other scales ranging from 0 to 100. A high score indicates significant dysfunction. QuickDASH Score = \[(Sum of responses / n) - 1\] X 25 n: the number of questions answered.

  The QuickDASH will be applied at 1 weeks after the surgical procedure.

• Quick-DASH functional scale

  In this project, the dysfunction and symptom component of the QuickDASH score, validated for Brazil and available online, will be used. The QuickDASH score is calculated as follows: At least 10 out of the 11 items must be answered. Each answered question will have a maximum value of 5. These values are then transformed into a score of 100 by subtracting 1 and multiplying by 25. This transformation is done to compare the scores with other scales ranging from 0 to 100. A high score indicates significant dysfunction. QuickDASH Score = \[(Sum of responses / n) - 1\] X 25 n: the number of questions answered.

  The QuickDASH will be applied at 2 weeks after the surgical procedure.

• Quick-DASH functional scale

  In this project, the dysfunction and symptom component of the QuickDASH score, validated for Brazil and available online, will be used. The QuickDASH score is calculated as follows: At least 10 out of the 11 items must be answered. Each answered question will have a maximum value of 5. These values are then transformed into a score of 100 by subtracting 1 and multiplying by 25. This transformation is done to compare the scores with other scales ranging from 0 to 100. A high score indicates significant dysfunction. QuickDASH Score = \[(Sum of responses / n) - 1\] X 25 n: the number of questions answered.

  The QuickDASH will be applied at 4 weeks after the surgical procedure.

• Quick-DASH functional scale

  In this project, the dysfunction and symptom component of the QuickDASH score, validated for Brazil and available online, will be used. The QuickDASH score is calculated as follows: At least 10 out of the 11 items must be answered. Each answered question will have a maximum value of 5. These values are then transformed into a score of 100 by subtracting 1 and multiplying by 25. This transformation is done to compare the scores with other scales ranging from 0 to 100. A high score indicates significant dysfunction. QuickDASH Score = \[(Sum of responses / n) - 1\] X 25 n: the number of questions answered.

  The QuickDASH will be applied at 8 weeks after the surgical procedure.

• Quick-DASH functional scale

  In this project, the dysfunction and symptom component of the QuickDASH score, validated for Brazil and available online, will be used. The QuickDASH score is calculated as follows: At least 10 out of the 11 items must be answered. Each answered question will have a maximum value of 5. These values are then transformed into a score of 100 by subtracting 1 and multiplying by 25. This transformation is done to compare the scores with other scales ranging from 0 to 100. A high score indicates significant dysfunction. QuickDASH Score = \[(Sum of responses / n) - 1\] X 25 n: the number of questions answered.

  The QuickDASH will be applied at 12 weeks after the surgical procedure.

Secondary Outcomes (24)

• Range of Motion

  Range of motion will be assessed after 1 day of the surgical procedure

• Range of Motion

  Range of motion will be assessed after 1 week of the surgical procedure

• Range of Motion

  Range of motion will be assessed after 2 weeks of the surgical procedure

• Range of Motion

  Range of motion will be assessed after 4 weeks of the surgical procedure

• Range of Motion

  Range of motion will be assessed after 8 weeks of the surgical procedure

Study Arms (2)

Photobiomodulation Group

EXPERIMENTAL

The shoulder brace (Cosmedical, Mauá, SP, Brazil) contains 159 red LEDs and 159 infrared LEDs interspersed. 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.

Procedure: Physiotherapy; Device: Photobiomodulation

Control Group

SHAM COMPARATOR

In the control group (standard physical therapy combined with simulated PBM), participants will receive an identical device to the active one, but only the light from the activation plug and the sound will be triggered when they press the button, while the internal LEDs will remain off.

Procedure: Physiotherapy; Device: Simulation of photobiomodulation

Interventions

Physiotherapy PROCEDURE

All participants will be treated with the standardized physiotherapy protocol suggested by Ratajczak et al. 2019. To receive physiotherapy treatment, participants will need to attend a 30-minute session, twice a week, for 12 weeks.

Control Group; Photobiomodulation Group

Photobiomodulation DEVICE

The PBM will be applied with LED devices in the form of a shoulder brace. The applications will occur every day starting 24 hours after the surgical procedure. The shoulder brace from the brand Cosmedical (Mauá, SP, Brazil) contains 70 red LEDs and 70 infrared LEDs. The area corresponding to the fixation plate will not be irradiated (no LEDs will be placed). PBM will be applied every day for 10 minutes using a device containing 318 light-emitting diodes (LEDs), including 159 LEDs at 660 nm (28.5 mW; 12 J/cm2 to 17 J) and 159 LEDs at 850 nm (23 mW; 10 J/cm2 to 14 J).

Photobiomodulation Group

Simulation of photobiomodulation DEVICE

The simulation of PBM will use the same LED devices in the form of a shoulder brace but without active light. It will be applied following the same regimen of the Photobiomodulation group.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

ACN Municipal Hospital

São Paulo, 03807-230, Brazil

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Humeral Fractures

Interventions

Physical Therapy Modalities; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Laser Therapy; Phototherapy

Study Officials

• Kristianne PS Fernandes, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristianne PS Fernandes, PhD

CONTACT

+55 11 3385-9241; kristianneporta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 1 Researcher, who will prepare the randomization and envelopes to ensure allocation concealment. 1 Researcher (resident physician) who will include subjects, open the envelope with the allocation, deliver the appropriate PBM device, and provide instructions. 4 Surgeons all surgical procedures and eligibility assessments. 4 Orthopedic physician evaluators (blinded to the experimental group of each participant), responsible for all evaluations from the postoperative period through outpatient follow-up. 1\. The Principal Investigator will be aware of the groups; he will centralize data collection and will not participate in any evaluations. 1 Physical Therapist (blinded to the experimental group of each participant) 3 resident Physicians (blinded to each participant's experimental group) will contact participants daily
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invertigator

Model Details: Forty-two participants will be randomly assigned (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.

Study Record Dates

• First Submitted: October 28, 2023
• First Posted: November 2, 2023
• Study Start: April 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: April 30, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared at the end of the study
• Access Criteria: Data will be shared at the end of the study for everyone who requests it

Locations

BR (1)