Evaluation of Photobiomodulation on Nasal Fractures

NCT04038645 | Withdrawn

• 1 other identifier: Nasal fracture
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasal Fracture

Keywords

Nasal Fracture; Photobiomodulation; Laser; Edema

Outcome Measures

Primary Outcomes (1)

• Edema

  It will be applied a grading system for evaluating eyelid edema: 0 point, none; 1 point, minimal; 2 points, extending on to the iris; 3 points, covering the iris; 4 points, massive edema with the eyelid swollen shut.

  Throughout study completion on average of one year

Secondary Outcomes (8)

• pain assessed by Vas

  Throughout study completion on average of one year

• Oral health related quality of life (OHRQoL) assessed by ohip-14

  Throughout study completion on average of one year

• C-reactive protein (CRP)

  Throughout study completion on average of one year

• temperature

  Throughout study completion on average of one year.

• Nasal Obstruction

  Throughout study completion on average of one year.

Study Arms (2)

Experimental Group (laser)

ACTIVE COMPARATOR

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.

Other: Experimental group (laser)

Control group (Placebo)

PLACEBO COMPARATOR

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.

Other: Control group (Placebo)

Interventions

Experimental group (laser) 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.

Experimental Group (laser)

Control group (Placebo) 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.

Control group (Placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (2)

• 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.

  PMID: 14646651 BACKGROUND

• 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.

  PMID: 24195796 BACKGROUND

MeSH Terms

Conditions

Edema

Interventions

Lasers; Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anna Carolina RT Horliana, Phd

  Nove de Julho University (Uninove)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only the researcher responsible for conducting the treatments (who will open the envelopes of the randomization) will know which treatment is assigned to each patient. The identification of each group will be revealed only after statistical analysis of the data for all those involved in the study by this researcher. Therefore, the researcher responsible for data collection (evaluation of edema and all secondary variables), the microbiologist and the statistician will be blind regarding the treatments assigned to the groups. The patient will also be blinded to the type of treatment performed, since the treatment with PBM will be identical in both groups and the treatment with PBM will be simulated in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 36 patients will be allocated in the experimental and control groups: G1 - Experimental Group (n = 18 Photobiomodulation PBM) - the treatment will be performed in a conventional manner and the patient will receive laser at low intensity. G2 - Control group (n = 18 -placebo of PBM) - treatment will be performed in a conventional manner and simulation of PBM treatment.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 31, 2019
• Study Start: December 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: October 15, 2020
• Last Updated: June 29, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share