Photobiomodulation Dosimetry s in Patients With Orofacial Pain

NCT ID: NCT06065969

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-11-20

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.

Detailed Description

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Conditions

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Orofacial Pain Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Local 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

Group Type ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type RADIATION

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

Vascular 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

Group Type EXPERIMENTAL

Photobiomodulation

Intervention Type RADIATION

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

sham local 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.

Group Type SHAM_COMPARATOR

Photobiomodulation

Intervention Type RADIATION

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

Sham Vascular 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

Group Type SHAM_COMPARATOR

Photobiomodulation

Intervention Type RADIATION

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

Interventions

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Photobiomodulation

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Lara Jansiski Motta

Principal Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 39405292 (View on PubMed)

Other Identifiers

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PBM

Identifier Type: -

Identifier Source: org_study_id

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