Bone FractureNCT06113614
Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
A study testing Physiotherapy, Photobiomodulation and Simulation of photobiomodulation in people with Bone Fracture and Humerus Fracture, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Fracture, Humerus Fracture, Surgery
- What is being tested?
- Physiotherapy, Photobiomodulation and Simulation of photobiomodulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Apr 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ACN Municipal Hospital
São Paulo, 03807-230
Luiz Claudio Freitas, MD, +55(11) 3394-8030
About this study
Official title: Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
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.
Read the detailed description
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
- Conditions
- Bone Fracture, Humerus Fracture, Surgery
- Being tested
- Physiotherapy, Photobiomodulation, Simulation of photobiomodulation
- Keywords
- photobiomodulation
- Medical subject headings
- Fractures, Bone, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyProcedure or surgery
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.
PhotobiomodulationDevice
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).
Simulation of photobiomodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Physiotherapy; Device: Simulation of photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The QuickDASH will be applied at 12 weeks after the surgical procedure.
Secondary outcomes (24)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Range of motion will be assessed after 4 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: It will be evaluated during a period of 12 weeks after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start30 Apr 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristianne Porta Santos Fernandes, University of Nove de Julho
- Investigators
- Kristianne PS Fernandes, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113614
- Sponsor's protocol ID
- 6.075.552
- Status last verified
- Jul 2024
- First submitted
- 28 Oct 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected data will be stored, and organized in a repository, and appropriate statistical tests will be applied to specific analyses
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06113614
- Acronym / sponsor ID
- 6.075.552
- Conditions
- Bone Fracture, Humerus Fracture, Surgery
- Keywords
- photobiomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Group | Experimental | Procedure: Physiotherapy, Device: PhotobiomodulationThe 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. |
| Control Group | Sham comparator | Procedure: Physiotherapy, Device: Simulation of photobiomodulationIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAll 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. | Procedure or surgery | Control Group, Photobiomodulation Group |
| PhotobiomodulationThe 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). | Device | Photobiomodulation Group |
| Simulation of photobiomodulationThe 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. | Device | Control Group |
Primary outcome
Quick-DASH functional scale
Time frame: The QuickDASH will be applied at 1 weeks after the surgical procedure.
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.
Quick-DASH functional scale
Time frame: The QuickDASH will be applied at 2 weeks after the surgical procedure.
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.
Quick-DASH functional scale
Time frame: The QuickDASH will be applied at 4 weeks after the surgical procedure.
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.
Quick-DASH functional scale
Time frame: The QuickDASH will be applied at 8 weeks after the surgical procedure.
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.
Quick-DASH functional scale
Time frame: The QuickDASH will be applied at 12 weeks after the surgical procedure.
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.
24 secondary outcomes
Range of Motion
Time frame: Range of motion will be assessed after 1 day of the surgical procedure
Range of Motion
Time frame: Range of motion will be assessed after 1 week of the surgical procedure
Range of Motion
Time frame: Range of motion will be assessed after 2 weeks of the surgical procedure
Range of Motion
Time frame: Range of motion will be assessed after 4 weeks of the surgical procedure
Range of Motion
Time frame: Range of motion will be assessed after 8 weeks of the surgical procedure
Range of Motion
Time frame: Range of motion will be assessed after 12 weeks of the surgical procedure
Muscle Strength
Time frame: 8th week of the surgical procedure
Muscle Strength
Time frame: 12th week of the surgical procedure
Pain Assessment
Time frame: It will be evaluated at 1 week of the surgical procedure
Pain Assessment
Time frame: It will be evaluated at 2 weeks of the surgical procedure
Pain Assessment
Time frame: It will be evaluated at 4 of the surgical procedure
Pain Assessment
Time frame: It will be evaluated at 8 weeks of the surgical procedure
Pain Assessment
Time frame: It will be evaluated at 12 weeks of the surgical procedure
Analgesic Consumption
Time frame: It will be evaluated during a period of 12 weeks after surgical procedure
SF-6 instrument
Time frame: It will be evaluated at 1 week after surgical procedure
SF-6 instrument
Time frame: It will be evaluated at 2 weeks after surgical procedure
SF-6 instrument
Time frame: It will be evaluated at 4 weeks after surgical procedure
SF-6 instrument
Time frame: It will be evaluated at 8 weeks after surgical procedure
SF-6 instrument
Time frame: It will be evaluated at 12 weeks after surgical procedure
Occurrence of Adverse Events
Time frame: It will be evaluated during a period of 12 weeks after surgical procedure
Fracture Healing
Time frame: It will be evaluated 4 weeks after surgical procedure
Fracture Healing
Time frame: It will be evaluated 8 weeks after surgical procedure
Fracture Healing
Time frame: It will be evaluated 12 weeks after surgical procedure
Procedure-Related Costs
Time frame: It will be evaluated during a period of 12 weeks after surgical procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Yes. Collected data will be stored, and organized in a repository, and appropriate statistical tests will be applied to specific analyses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristianne PS Fernandes, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy, Photobiomodulation and Simulation of photobiomodulation in people with Bone Fracture and Humerus Fracture, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristianne PS Fernandes, PhD (+55 11 3385-9241, kristianneporta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick-DASH functional scale (time frame: The QuickDASH will be applied at 1 weeks after the surgical procedure.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.