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NCT06065969 Clinical Trial

Photobiomodulation Dosimetry s in Patients With Orofacial Pain

Tension-Type Headache Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06065969
Other study ID # PBM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 10, 2023
Est. completion date November 20, 2024

Study information
Verified date September 2023
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 240
Est. completion date November 20, 2024
Est. primary completion date December 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Photobiomodulation
660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Nove de Julho

Outcome
Type Measure Description Time frame Safety issue
Primary Headache and orofacial pain Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10. two weeks
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