Photobiomodulation Dosimetry s in Patients With Orofacial Pain

University of Nove de Julho

Status: Not yet enrolling

Conditions: Tension-Type Headache; Orofacial Pain

Treatments: Radiation: Photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06065969

PBM

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 7 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Local photobiomodulation

Active Comparator group

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

Treatment:

Radiation: Photobiomodulation

Vascular photobiomodulation

Experimental group

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

Treatment:

Radiation: Photobiomodulation

sham local photobiomodulation

Sham Comparator group

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.

Treatment:

Radiation: Photobiomodulation

Sham Vascular photobiomodulation

Sham Comparator group

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

Treatment:

Radiation: Photobiomodulation