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.
Among the complications of postoperative recovery from proximal humerus fractures (PHF) are pain and joint stiffness, which can significantly limit limb function. Physical therapy is standard for both surgical and non-surgical treatments. Research suggests that photobiomodulation (PBM) positively affects fracture repair, regeneration, analgesia, and functional improvement, but more standardization and evidence are needed. This double-blind, randomized controlled study aims to assess PBM's impact on functional recovery in patients with surgically treated PHF using specialized locking plates. Forty-two participants will be randomly assigned (1:1) to either the Control group (standard physiotherapy with simulated PBM) or the FBM group (standard physiotherapy with active PBM). The PBM will be administered at home daily for 10 minutes using a device with 318 LEDs: 159 at 660 nm (28.5 mW; 12 J/cm²; 17 J per LED) and 159 at 850 nm (23 mW; 10 J/cm²; 14 J per LED). PBM and physiotherapy sessions (30 minutes, twice a week) will continue for 12 weeks. Participants and examiners will be blinded to group allocation. The primary outcome is shoulder function recovery, measured by the Quick-DASH scale, that will be evaluated 1, 2, 4, 8, and 12 weeks after surgery . Secondary outcomes include shoulder range of motion (digital goniometer), quality of life (SF-6 questionnaire), and adverse effects. The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil) at 1, 2, 4, 8, and 12 weeks. Fracture consolidation via radiographs at 4, 8, and 12 weeks, and muscle strength through progressive weight bearing at 8 and 12 weeks. Data will be stored, organized, and analyzed using appropriate statistical tests, with a significance level set at 5%. Keywords: Photobiomodulation, Humerus Fracture, Quick-DASH, Quality of life, Phototherapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
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.
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).
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.
ACN Municipal Hospital
São Paulo, Brazil
RECRUITINGQuick-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.
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.
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.
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.
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 12 weeks after the surgical procedure.
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 procedure
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 procedure
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 procedure
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 procedure
Range of Motion
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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 8 weeks of the surgical procedure
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 12 weeks of the surgical procedure
Muscle Strength
Muscle strength will be assessed by progressive holding of dumbbells with elbow flexion (RLM, Maringá, Paraná, Brazil), starting with 500 grams and progressing to 5 kg in the 8th and 12th weeks.
Time frame: 8th week of the surgical procedure
Muscle Strength
Muscle strength will be assessed by progressive holding of dumbbells with elbow flexion (RLM, Maringá, Paraná, Brazil), starting with 500 grams and progressing to 5 kg in the 8th and 12th weeks.
Time frame: 12th week of the surgical procedure
Pain Assessment
The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil)
Time frame: It will be evaluated at 1 week of the surgical procedure
Pain Assessment
The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil)
Time frame: It will be evaluated at 2 weeks of the surgical procedure
Pain Assessment
The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil)
Time frame: It will be evaluated at 4 of the surgical procedure
Pain Assessment
The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil)
Time frame: It will be evaluated at 8 weeks of the surgical procedure
Pain Assessment
The intensity of spontaneous pain and pain during movement of the injured limb will be assessed using the visual analog scale for pain. Pressure pain at the fracture site will be evaluated with a digital algometer (MED DOR, Governador Valadares, MG, Brazil)
Time frame: It will be evaluated at 12 weeks of the surgical procedure
Analgesic Consumption
The type and dosage of analgesics consumed will be inquired during the daily control of PBM use and will be recorded on the participant's daily control form.
Time frame: It will be evaluated during a period of 12 weeks after surgical procedure
SF-6 instrument
Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.
Time frame: It will be evaluated at 1 week after surgical procedure
SF-6 instrument
Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.
Time frame: It will be evaluated at 2 weeks after surgical procedure
SF-6 instrument
Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.
Time frame: It will be evaluated at 4 weeks after surgical procedure
SF-6 instrument
Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.
Time frame: It will be evaluated at 8 weeks after surgical procedure
SF-6 instrument
Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.
Time frame: It will be evaluated at 12 weeks after surgical procedure
Occurrence of Adverse Events
The occurrence of adverse events will be inquired during the daily control of PBM use and will be recorded on the participant's daily control form
Time frame: It will be evaluated during a period of 12 weeks after surgical procedure
Fracture Healing
Shoulder X-rays in the anteroposterior, scapular profile, and axillary incidences will be taken after 4, 8, and 12 weeks to assess bone healing, defined by the presence of a bony callus in 3 of the 4 bone cortices joining the main fracture fragments and compared with the X-ray taken immediately post-surgery.
Time frame: It will be evaluated 4 weeks after surgical procedure
Fracture Healing
Shoulder X-rays in the anteroposterior, scapular profile, and axillary incidences will be taken after 4, 8, and 12 weeks to assess bone healing, defined by the presence of a bony callus in 3 of the 4 bone cortices joining the main fracture fragments and compared with the X-ray taken immediately post-surgery.
Time frame: It will be evaluated 8 weeks after surgical procedure
Fracture Healing
Shoulder X-rays in the anteroposterior, scapular profile, and axillary incidences will be taken after 4, 8, and 12 weeks to assess bone healing, defined by the presence of a bony callus in 3 of the 4 bone cortices joining the main fracture fragments and compared with the X-ray taken immediately post-surgery.
Time frame: It will be evaluated 12 weeks after surgical procedure
Procedure-Related Costs
The costs of all procedures will be documented based on the Brazilian Unified Health System (SUS) price list
Time frame: It will be evaluated during a period of 12 weeks after surgical procedure