Photobiomodulation Dosimetry s in Patients With Orofacial Pain

NCT06065969 | Unknown

• 1 other identifier: PBM
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orofacial Pain; Tension-Type Headache

Keywords

orofacial pain; Tension-Type Headache; photobiomodulation

Outcome Measures

Primary Outcomes (1)

• Headache and orofacial pain

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

  two weeks

Study Arms (4)

Local photobiomodulation

ACTIVE COMPARATOR

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

Vascular photobiomodulation

EXPERIMENTAL

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

sham local photobiomodulation

SHAM COMPARATOR

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

Sham Vascular photobiomodulation

SHAM COMPARATOR

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

Interventions

Photobiomodulation RADIATION

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

Local photobiomodulation; Sham Vascular photobiomodulation; Vascular photobiomodulation; sham local photobiomodulation

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• Schuler SSV, Campos MCV, Lacerda AJ, Mazzoni AC, Silva T, Silva FCD, Martins MD, Fernandes KPS, Fonseca ES, Mesquita-Ferrari RA, Horliana ACRT, Bussadori SK, Motta LJ. Dosimetry model for photobiomodulation based on anthropometric and hemodynamic variables in patients with orofacial pain post-Covid-19: Study protocol for randomized clinical trial. PLoS One. 2024 Oct 15;19(10):e0309073. doi: 10.1371/journal.pone.0309073. eCollection 2024.

  PMID: 39405292 DERIVED

MeSH Terms

Conditions

Facial Pain; Tension-Type Headache

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 4, 2023
• Study Start: October 10, 2023
• Primary Completion: December 10, 2023
• Study Completion: November 20, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share