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NCT Number: NCT06113614

Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

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.

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Key information

Conditions

Bone Fracture Arm Injuries Fractures, Bone Humeral Fractures Humerus Fracture Surgery Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ACN Municipal Hospital

São Paulo, 03807-230, Brazil

Location status: Recruiting

Location contact

Luiz Claudio Freitas, MD

CONTACT

+55(11) 3394-8030

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The subjects selected for inclusion will be individuals of both genders treated at HMACN hospital, with isolated and closed proximal humerus fractures with displacement and surgical indication, undergoing open reduction and internal fixation (ORIF) with a locking angular stability plate for the proximal humerus (Neer 1070, Carrera et al., 2012; Petros, 2019), and meeting the following eligibility criteria.

Individuals aged between 18 and 65 years, of both genders, with proximal humerus fractures classified as:

Neer group III Neer group IV Neer group V AO/OTA subgroups A2 and A3 AO/OTA group B AO/OTA group C (only for patients under 55 years of age)

Exclusion criteria

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.

Treatment and study plan

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.

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).

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Range of Motion

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

    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).

  2. Range of Motion

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

    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).

  3. Range of Motion

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

    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).

  4. Range of Motion

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

    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).

  5. Range of Motion

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

    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).

  6. Range of Motion

    Time frame: Range of motion will be assessed after 12 weeks of the surgical procedure

    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).

  7. Muscle Strength

    Time frame: 8th week of the surgical procedure

    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.

  8. Muscle Strength

    Time frame: 12th week of the surgical procedure

    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.

  9. Pain Assessment

    Time frame: It will be evaluated at 1 week of the surgical procedure

    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)

  10. Pain Assessment

    Time frame: It will be evaluated at 2 weeks of the surgical procedure

    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)

  11. Pain Assessment

    Time frame: It will be evaluated at 4 of the surgical procedure

    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)

  12. Pain Assessment

    Time frame: It will be evaluated at 8 weeks of the surgical procedure

    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)

  13. Pain Assessment

    Time frame: It will be evaluated at 12 weeks of the surgical procedure

    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)

  14. Analgesic Consumption

    Time frame: It will be evaluated during a period of 12 weeks after surgical procedure

    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.

  15. SF-6 instrument

    Time frame: It will be evaluated at 1 week after surgical procedure

    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.

  16. SF-6 instrument

    Time frame: It will be evaluated at 2 weeks after surgical procedure

    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.

  17. SF-6 instrument

    Time frame: It will be evaluated at 4 weeks after surgical procedure

    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.

  18. SF-6 instrument

    Time frame: It will be evaluated at 8 weeks after surgical procedure

    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.

  19. SF-6 instrument

    Time frame: It will be evaluated at 12 weeks after surgical procedure

    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.

  20. Occurrence of Adverse Events

    Time frame: It will be evaluated during a period of 12 weeks after surgical procedure

    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

  21. Fracture Healing

    Time frame: It will be evaluated 4 weeks after surgical procedure

    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.

  22. Fracture Healing

    Time frame: It will be evaluated 8 weeks after surgical procedure

    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.

  23. Fracture Healing

    Time frame: It will be evaluated 12 weeks after surgical procedure

    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.

  24. Procedure-Related Costs

    Time frame: It will be evaluated during a period of 12 weeks after surgical procedure

    The costs of all procedures will be documented based on the Brazilian Unified Health System (SUS) price list

Study contacts

Contact information is provided by the study sponsor or research team.

Kristianne PS Fernandes, PhD

CONTACT

[email protected]

+55 11 3385-9241

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 2, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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