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Photobiomodulation Dosimetry s in Patients With Orofacial Pain

Primary Purpose

Orofacial Pain, Tension-Type Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orofacial Pain focused on measuring orofacial pain, Tension-Type Headache, photobiomodulation

Eligibility Criteria

7 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Individuals of both sexes, between 7 and 65 years of age Exclusion Criteria Participants with the following characteristics will be excluded: Pregnant individuals Individuals with arrhythmia Individuals with Thrombocytopenia Individuals with Sickle Cell Anemia Individuals with a pacemaker Individuals with alterations in coagulation factors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Sham Comparator

    Sham Comparator

    Arm Label

    Local photobiomodulation

    Vascular photobiomodulation

    sham local photobiomodulation

    Sham Vascular photobiomodulation

    Arm Description

    Delivering an energy of 6J per point (60 seconds) at 2 points in the masseter muscle region, 1 point in the temporal muscle, and 1 point in the trapezius muscle in the cervical region. The total application will take 4 minutes per session

    660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session. The participant will be seated in a comfortable chair with side support for resting their arms during the application

    The same procedures described for local photobiomodulation will be followed; however, the equipment will emit only the sound signal, exactly like the equipment used in local photobiomodulation group, without emitting laser light.

    The same procedures described for vascular photobiomodulation will be followed; however, the equipment will emit only the sound signal, exactly like the equipment used in vascular photobiomodulation group, without emitting laser light

    Outcomes

    Primary Outcome Measures

    Headache and orofacial pain
    Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    September 29, 2023
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06065969
    Brief Title
    Photobiomodulation Dosimetry s in Patients With Orofacial Pain
    Official Title
    Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 10, 2023 (Anticipated)
    Primary Completion Date
    December 10, 2023 (Anticipated)
    Study Completion Date
    November 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This project aims to validate a dosimetry model for photobiomodulation treatment in patients with orofacial pain and tension-type headache symptoms. The study will involve 240 participants divided into four age groups. Different treatment approaches will be applied, including local photobiomodulation and systemic laser therapy. Various physiological measurements will be taken before, during, and after the treatments, including skin type, weight, height, blood pressure, and heart rate. Additionally, data from questionnaires on pain and headache symptoms will be analyzed. Monte Carlo simulation will be employed to validate the model based on these measurements and light transmission. The research addresses the need for effective pain management strategies in cases where medication-based treatments may have unwanted side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orofacial Pain, Tension-Type Headache
    Keywords
    orofacial pain, Tension-Type Headache, photobiomodulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Local photobiomodulation
    Arm Type
    Active Comparator
    Arm Description
    Delivering an energy of 6J per point (60 seconds) at 2 points in the masseter muscle region, 1 point in the temporal muscle, and 1 point in the trapezius muscle in the cervical region. The total application will take 4 minutes per session
    Arm Title
    Vascular photobiomodulation
    Arm Type
    Experimental
    Arm Description
    660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session. The participant will be seated in a comfortable chair with side support for resting their arms during the application
    Arm Title
    sham local photobiomodulation
    Arm Type
    Sham Comparator
    Arm Description
    The same procedures described for local photobiomodulation will be followed; however, the equipment will emit only the sound signal, exactly like the equipment used in local photobiomodulation group, without emitting laser light.
    Arm Title
    Sham Vascular photobiomodulation
    Arm Type
    Sham Comparator
    Arm Description
    The same procedures described for vascular photobiomodulation will be followed; however, the equipment will emit only the sound signal, exactly like the equipment used in vascular photobiomodulation group, without emitting laser light
    Intervention Type
    Radiation
    Intervention Name(s)
    Photobiomodulation
    Intervention Description
    660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.
    Primary Outcome Measure Information:
    Title
    Headache and orofacial pain
    Description
    Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10.
    Time Frame
    two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria Individuals of both sexes, between 7 and 65 years of age Exclusion Criteria Participants with the following characteristics will be excluded: Pregnant individuals Individuals with arrhythmia Individuals with Thrombocytopenia Individuals with Sickle Cell Anemia Individuals with a pacemaker Individuals with alterations in coagulation factors

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Photobiomodulation Dosimetry s in Patients With Orofacial Pain

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