Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Nove de Julho
About this trial
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
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Physiotherapy
Procedure/SurgeryAll 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.
Photobiomodulation
DeviceThe 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).
Simulation of photobiomodulation
DeviceThe 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Photobiomodulation GroupExperimental treatment 2 interventions
Group B: Control GroupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
The QuickDASH will be applied at 1 weeks after the surgical procedure.2
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.
Time frame
The QuickDASH will be applied at 2 weeks after the surgical procedure.3
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.
Time frame
The QuickDASH will be applied at 4 weeks after the surgical procedure.4
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.
Time frame
The QuickDASH will be applied at 8 weeks after the surgical procedure.Secondary outcomes
1
Range of Motion
The passive range of motion of the shoulder on both sides will be assessed with the participant in an upright position. The maximum tolerated position for extension, flexion, abduction, adduction, external rotation, and internal rotation will be noted by the evaluator. Rotations will be evaluated at 0° of abduction and flexion. All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).
Time frame
Range of motion will be assessed after 1 day of the surgical procedure2
Range of Motion
The passive range of motion of the shoulder on both sides will be assessed with the participant in an upright position. The maximum tolerated position for extension, flexion, abduction, adduction, external rotation, and internal rotation will be noted by the evaluator. Rotations will be evaluated at 0° of abduction and flexion. All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).
Time frame
Range of motion will be assessed after 1 week of the surgical procedure3
Range of Motion
The passive range of motion of the shoulder on both sides will be assessed with the participant in an upright position. The maximum tolerated position for extension, flexion, abduction, adduction, external rotation, and internal rotation will be noted by the evaluator. Rotations will be evaluated at 0° of abduction and flexion. All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).
Time frame
Range of motion will be assessed after 2 weeks of the surgical procedure4
Range of Motion
The passive range of motion of the shoulder on both sides will be assessed with the participant in an upright position. The maximum tolerated position for extension, flexion, abduction, adduction, external rotation, and internal rotation will be noted by the evaluator. Rotations will be evaluated at 0° of abduction and flexion. All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).
Time frame
Range of motion will be assessed after 4 weeks of the surgical procedureSponsors and contacts
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Source ClinicalTrials.gov