Evaluation of Photobiomodulation on Nasal Fractures

Summary

Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Regression of edema in a shorter time may decrease hospitalization time, decreasing hospital costs. However, there are no well-designed clinical studies on this subject. Therefore, the objective of this study will be to evaluate if PBM is able to reduce edema in the region of fractured nasal bones prior to nasal reduction and nasal packing, in order to reduce the patient's ability to go through surgery. Thirty-six patients diagnosed with a (primary) nasal fracture admitted to the Mandaqui Hospital Complex whose trauma occurred in the last 48 hours will be randomly divided into: G1- (control) (n = 18). . G2-Light emitter diode (LED) group (n = 18) - The standard hospital treatment will be performed + LED nasal mask. The main variable will be the edema evaluated by the same researcher and with the same technique. Secondary variables will be pain (visual analogue scale - VAS), temperature, rescue medication count, serum C-reactive protein and systemic inflammatory cytokines. Afterwards, the LED or its placebo will also be applied. The questionnaire to assess the impact of treatment on quality of life will be applied at the baseline and after 8 days. Adverse effects will be recorded and reported. If the data is normal, they will be submitted to Student's t-test. The data will be presented by their means ± standard deviation (SD) and the value of p will be set at 0.05.

Conditions

• Nasal Fracture

Interventions

OTHER

Experimental group (laser)

The patients will receive infrared LEDs in 6 points using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt. During application of the LED both patient and operator will wear goggles. The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol.

OTHER

Control group (Placebo)

Patients will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days as well as the evaluation of serum CRP.

Sponsors & Collaborators

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Anna Carolina RT Horliana, Phd · Nove de Julho University (Uninove)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2019-12-30

Completion

2020-10-15