Photobiomodulation Dosimetry s in Patients With Orofacial Pain

Study Overview
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Brief Summary
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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.

Official Title
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Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain

Conditions
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Orofacial Pain, Tension-Type Headache

Intervention / Treatment
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* Radiation: Photobiomodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local photobiomodulation<br>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 | Radiation: Photobiomodulation<br>* 660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.<br>|
| Experimental: Vascular photobiomodulation<br>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 | Radiation: Photobiomodulation<br>* 660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.<br>|
| Sham Comparator: sham local photobiomodulation<br>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. | Radiation: Photobiomodulation<br>* 660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.<br>|
| Sham Comparator: Sham Vascular photobiomodulation<br>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 | Radiation: Photobiomodulation<br>* 660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache and orofacial pain | Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10. | two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orofacial pain, Tension-Type Headache, photobiomodulation