Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06113614
• Other study ID #: 6.075.552
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: October 2023
• Source: University of Nove de Julho
• Contact: Kristianne PS Fernandes, PhD
• Phone: +55 11 3385-9241
• Email: kristianneporta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-blind, randomized controlled clinical study aims to evaluate the effects of PBM on the functional recovery of participants with surgically treated PHF using special locking plates. The 42 participants will be randomized (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. Participants will be unaware of their group allocation and will be assessed at 24 hours, 1, 2, 4, 8, and 12 weeks after surgery by four examiners who are also blinded to each participant's allocation. The primary outcome, assessed at all time points, 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 using the SF-6 questionnaire, and the occurrence of adverse effects at all time points. Spontaneous pain, pressure pain (measured with a dolorimeter), nighttime pain, and analgesic use will be evaluated at 1, 2, 4, 8, and 12 weeks. Fracture consolidation will be assessed at 4, 8, and 12 weeks through radiographic examinations, and muscle strength will be evaluated by progressive dumbbell support at 8 and 12 weeks. In addition to the scheduled assessments, participants will be contacted daily by phone.

Description:

Among the various complications in the postoperative course of proximal humerus fractures (PHF), pain and joint stiffness are common, leading to significant functional limitations in the affected limb. Physical therapy is the standard treatment for functional recovery, both for surgical and non-surgical cases. Studies have shown positive effects of photobiomodulation (PBM) on fracture repair, regeneration, pain relief, and functional improvement. However, there is a need for standardization and additional evidence. This double-blind, randomized controlled clinical study aims to evaluate the effects of PBM on the functional recovery of participants with surgically treated PHF using special locking plates. The 42 participants will be randomized (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. Participants will be unaware of their group allocation and will be assessed at 24 hours, 1, 2, 4, 8, and 12 weeks after surgery by four examiners who are also blinded to each participant's allocation. The primary outcome, assessed at all time points, 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 using the SF-6 questionnaire, and the occurrence of adverse effects at all time points. Spontaneous pain, pressure pain (measured with a dolorimeter), nighttime pain, and analgesic use will be evaluated at 1, 2, 4, 8, and 12 weeks. Fracture consolidation will be assessed at 4, 8, and 12 weeks through radiographic examinations, and muscle strength will be evaluated by progressive dumbbell support at 8 and 12 weeks. In addition to the scheduled assessments, participants will be contacted daily by phone. Collected data will be stored, and organized in a repository, and appropriate statistical tests will be applied for each specific analysis. In all tests, a significance level of 5% will be adopted.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: April 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Subjects of both genders treated at the HMACN Hospital with isolated and closed proximal humerus fractures with displacement and surgical indication undergoing RAFI with an angular stable locked plate for the proximal humerus (Neer 1070, Carrerra et al. 2012, Petros 2019) will be selected for inclusion according to the following eligibility criteria.

Individuals aged between 18 and 75, of both genders, with PHF classified as:

• Neer Group II only in patients under 55 years old
• Neer Group III
• Neer Group IV
• Neer Group V, 3 parts
• Displaced fractures
• AO/OTA subgroups A1.1, A2, and A3
• AO/OTA Group B
• AO/OTA Group C only in patients under 55 years old.

Individuals will be excluded if they:

• Have pre-existing shoulder or scapular injuries or motor deficits resulting from central or peripheral neurological injuries.
• Have pathological fractures.
• Develop post-operative infection or implant loosening.
• Have ipsilateral fractures in other limb regions.
• Present neurovascular injury with sensory deficits at the site of the injury.
• Have local or systemic conditions that contraindicate surgery or complicate the post-operative period.
• Have a history of photosensitivity.
• Have neurological and psychiatric disorders.
• Have proliferative or infectious skin lesions in the shoulder area that will receive LED light.
• Have used anti-inflammatories in the 5 days prior to the trauma.
• Are pregnant.
• Experience surgical complications such as neurological or vascular injuries, as well as fracture line extension during the surgical procedure, as they will not meet the desired standard of progress

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone
• Humeral Fractures
• Humerus Fracture
• Surgery

Intervention

Procedure:
• Physiotherapy
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.

Device:
• Photobiomodulation
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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 (Gracitelli 2015, Tenor Junior et al 2016). All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).	Range of motion will be assessed after 1 day of the surgical procedure
Secondary	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 (Gracitelli 2015, Tenor Junior et al 2016). All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).	Range of motion will be assessed after 1 week of the surgical procedure
Secondary	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 (Gracitelli 2015, Tenor Junior et al 2016). All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).	Range of motion will be assessed after 2 weeks of the surgical procedure
Secondary	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 (Gracitelli 2015, Tenor Junior et al 2016). All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).	Range of motion will be assessed after 4 weeks of the surgical procedure
Secondary	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 (Gracitelli 2015, Tenor Junior et al 2016). All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).	Range of motion will be assessed after 8 weeks of the surgical procedure
Secondary	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 (Gracitelli 2015, Tenor Junior et al 2016). All measurements will be performed with a digital goniometer (Kaptron 360, Shenzhen, Dongguan China).	Range of motion will be assessed after 12 weeks of the surgical procedure
Secondary	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 (Barbosa et al 2008).	8th week of the surgical procedure
Secondary	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 (Barbosa et al 2008).	12th week of the surgical procedure
Secondary	Pain Assessment	The intensity of spontaneous and function-related pain of the injured limb will be assessed using the visual analog pain scale (Jensen et al 1986). This scale consists of a 10 cm line with the phrases "absence of pain" and "unbearable pain" at the two extremes.	It will be evaluated at 1 week of the surgical procedure
Secondary	Pain Assessment	The intensity of spontaneous and function-related pain of the injured limb will be assessed using the visual analog pain scale (Jensen et al 1986). This scale consists of a 10 cm line with the phrases "absence of pain" and "unbearable pain" at the two extremes.	It will be evaluated at 2 weeks of the surgical procedure
Secondary	Pain Assessment	The intensity of spontaneous and function-related pain of the injured limb will be assessed using the visual analog pain scale (Jensen et al 1986). This scale consists of a 10 cm line with the phrases "absence of pain" and "unbearable pain" at the two extremes.	It will be evaluated at 4 of the surgical procedure
Secondary	Pain Assessment	The intensity of spontaneous and function-related pain of the injured limb will be assessed using the visual analog pain scale (Jensen et al 1986). This scale consists of a 10 cm line with the phrases "absence of pain" and "unbearable pain" at the two extremes.	It will be evaluated at 8 weeks of the surgical procedure
Secondary	Pain Assessment	The intensity of spontaneous and function-related pain of the injured limb will be assessed using the visual analog pain scale (Jensen et al 1986). This scale consists of a 10 cm line with the phrases "absence of pain" and "unbearable pain" at the two extremes.	It will be evaluated at 12 weeks of the surgical procedure
Secondary	Analgesic Consumption	The type and dosage of analgesics consumed will be inquired during the daily control of FBM use and will be recorded on the participant's daily control form.	It will be evaluated during a period of 12 weeks after surgical procedure
Secondary	SF-6 instrument	Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil (Campolina et al 2011) at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.	It will be evaluated at 1 week after surgical procedure
Secondary	SF-6 instrument	Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil (Campolina et al 2011) at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.	It will be evaluated at 2 weeks after surgical procedure
Secondary	SF-6 instrument	Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil (Campolina et al 2011) at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.	It will be evaluated at 4 weeks after surgical procedure
Secondary	SF-6 instrument	Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil (Campolina et al 2011) at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.	It will be evaluated at 8 weeks after surgical procedure
Secondary	SF-6 instrument	Quality of life will be assessed using the SF-6 instrument from 2002 in the version adapted for use in Brazil (Campolina et al 2011) at 1, 2, 4, 8, and 12 weeks, with the results recorded in the respective clinical records for each experimental period.	It will be evaluated at 12 weeks after surgical procedure
Secondary	Occurrence of Adverse Events	The occurrence of adverse events will be inquired during the daily control of FBM use and will be recorded on the participant's daily control form	It will be evaluated during a period of 12 weeks after surgical procedure
Secondary	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 (Gracitelli 2015).	It will be evaluated 4 weeks after surgical procedure
Secondary	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 (Gracitelli 2015).	It will be evaluated 8 weeks after surgical procedure
Secondary	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 (Gracitelli 2015).	It will be evaluated 12 weeks after surgical procedure
Secondary	Procedure-Related Costs	The costs of all procedures will be documented based on the Brazilian Unified Health System (SUS) price list	It will be evaluated during a period of 12 weeks after surgical procedure