Evaluation of Photobiomodulation on Nasal Fractures

NCT ID: NCT04038645

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-10-15

Brief 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.

Detailed Description

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). The control group will be submitted to the standard hospital treatment: standard drug therapy (50mg diclofenac sodium - 5 days, 8 / 8h orally and 500mg dipyrone - 5 days, 6 / 6h , orally). Tylex 30mg orally will be given as rescue medication. In this group there will be simulation of the use of the mask. G2- LED group (n = 18) - The standard hospital treatment will be performed + LED nasal mask (3 points on each side of the nose), λ = 830nm, radiant exposure of 9.7 Joules J / cm2 for 10 minutes. Treatment will be performed at patient admission (up to 24 hours after nasal trauma), and at intervals explained below, for approximately 08 days after hospital admission. 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 (TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL- nasal fossa and saliva. All evaluations will be performed at baseline (T0) up to 48 hours after trauma, aiming at equivalence in the inflammatory process, (T1) 96h after trauma and (T2) 192h after trauma. 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 ± SD and the value of p will be set at 0.05.

Conditions

Nasal Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group (laser)

The patients (n=18) will receive infrared LEDs in 6 points (3 on the right side and 3 on the left side) using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt (mW) . The LED light outputs will be positioned in direct contact with the skin. 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.

Group Type: ACTIVE_COMPARATOR

Experimental group (laser)

Intervention Type: OTHER

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.

Control group (Placebo)

The patients (n=18) 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 (by the same evaluator), as well as the evaluation of serum CRP.

Group Type: PLACEBO_COMPARATOR

Control group (Placebo)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy participants.
• With a maximum of 48 hours after nasal trauma.

Exclusion Criteria

• Patients using anticoagulant medication or use of medication that is anti-inflammatory chronically .
• Patients who report a hypersensitivity reaction to any drug used in the research
• Patients with previous nasal fractures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Anna Carolina Ratto Tempestini Horliana

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Carolina RT Horliana, Phd

Role: PRINCIPAL_INVESTIGATOR

Nove de Julho University (Uninove)

References

Kargi E, Hosnuter M, Babuccu O, Altunkaya H, Altinyazar C. Effect of steroids on edema, ecchymosis, and intraoperative bleeding in rhinoplasty. Ann Plast Surg. 2003 Dec;51(6):570-4. doi: 10.1097/01.sap.0000095652.35806.c5.

Reference Type: BACKGROUND

PMID: 14646651 (View on PubMed)

Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial. Trials. 2013 Nov 6;14:373. doi: 10.1186/1745-6215-14-373.

Reference Type: BACKGROUND

PMID: 24195796 (View on PubMed)

Other Identifiers

Nasal fracture

Identifier Type: -

Identifier Source: org_study_id