Clinical trial NCT06113614: Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures
Official title: Effects of Photobiomodulation on Functional Recovery of Proximal Humerus Fractures: a Double-blind Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Fracture
Humerus Fracture
Surgery
Keywords: photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: 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.

Primary outcomes:
measure: Quick-DASH functional scale
timeFrame: The QuickDASH will be applied at 1 weeks after the surgical procedure.
measure: Quick-DASH functional scale
timeFrame: The QuickDASH will be applied at 2 weeks after the surgical procedure.
measure: Quick-DASH functional scale
timeFrame: The QuickDASH will be applied at 4 weeks after the surgical procedure.
measure: Quick-DASH functional scale
timeFrame: The QuickDASH will be applied at 8 weeks after the surgical procedure.
measure: Quick-DASH functional scale
timeFrame: The QuickDASH will be applied at 12 weeks after the surgical procedure.
Secondary outcomes:
measure: Range of Motion
timeFrame: Range of motion will be assessed after 1 day of the surgical procedure
measure: Range of Motion
timeFrame: Range of motion will be assessed after 1 week of the surgical procedure
measure: Range of Motion
timeFrame: Range of motion will be assessed after 2 weeks of the surgical procedure
measure: Range of Motion
timeFrame: Range of motion will be assessed after 4 weeks of the surgical procedure
measure: Range of Motion
timeFrame: Range of motion will be assessed after 8 weeks of the surgical procedure
measure: Range of Motion
timeFrame: Range of motion will be assessed after 12 weeks of the surgical procedure
measure: Muscle Strength
timeFrame: 8th week of the surgical procedure
measure: Muscle Strength
timeFrame: 12th week of the surgical procedure
measure: Pain Assessment
timeFrame: It will be evaluated at 1 week of the surgical procedure
measure: Pain Assessment
timeFrame: It will be evaluated at 2 weeks of the surgical procedure
measure: Pain Assessment
timeFrame: It will be evaluated at 4 of the surgical procedure
measure: Pain Assessment
timeFrame: It will be evaluated at 8 weeks of the surgical procedure
measure: Pain Assessment
timeFrame: It will be evaluated at 12 weeks of the surgical procedure
measure: Analgesic Consumption
timeFrame: It will be evaluated during a period of 12 weeks after surgical procedure
measure: SF-6 instrument
timeFrame: It will be evaluated at 1 week after surgical procedure
measure: SF-6 instrument
timeFrame: It will be evaluated at 2 weeks after surgical procedure
measure: SF-6 instrument
timeFrame: It will be evaluated at 4 weeks after surgical procedure
measure: SF-6 instrument
timeFrame: It will be evaluated at 8 weeks after surgical procedure
measure: SF-6 instrument
timeFrame: It will be evaluated at 12 weeks after surgical procedure
measure: Occurrence of Adverse Events
timeFrame: It will be evaluated during a period of 12 weeks after surgical procedure
measure: Fracture Healing
timeFrame: It will be evaluated 4 weeks after surgical procedure
measure: Fracture Healing
timeFrame: It will be evaluated 8 weeks after surgical procedure
measure: Fracture Healing
timeFrame: It will be evaluated 12 weeks after surgical procedure
measure: Procedure-Related Costs
timeFrame: It will be evaluated during a period of 12 weeks after surgical procedure
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: ACN Municipal Hospital
Study officials:
affiliation: University of Nove de Julho
name: Kristianne PS Fernandes, PhD
role: PRINCIPAL_INVESTIGATOR
References: