Photobiomodulation Dosimetry s in Patients With Orofacial Pain

Not Applicable

Not yet recruiting

• Conditions: Tension-Type Headache; Orofacial Pain
• Interventions: Radiation: Photobiomodulation

• Registration Number: NCT06065969
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Study First Posted: 2023-10-04
• Last Update Posted: 2023-10-04
• Study Start: 2023-10-10
• Primary Completion: 2023-12-10
• Study Completion: 2024-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham local photobiomodulation	Photobiomodulation	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.
Sham Vascular photobiomodulation	Photobiomodulation	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
Local photobiomodulation	Photobiomodulation	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
Vascular photobiomodulation	Photobiomodulation	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

Primary Outcome Measures

Name	Time	Method
Headache and orofacial pain	two weeks	Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10.