Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain
| Registry | NCT06065969 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 240 (Estimated) |
| Sponsor | University of Nove de Julho (Other) |
| Conditions | Orofacial Pain, Tension-Type Headache |
| Interventions | Photobiomodulation (Radiation) |
| Dates | start 2023-10-10 (estimated), primary completion 2023-12-10 (estimated), completion 2024-11-20 (estimated), first posted 2023-10-04, last updated 2023-10-04 |
Related Papers Related Patents Related Grants Related Experts
All trials for Orofacial Pain All trials for Tension-Type Headache All trials of Photobiomodulation
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Local photobiomodulation | Active comparator | Radiation: 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 | Experimental | Radiation: 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 |
| sham local photobiomodulation | Sham comparator | Radiation: 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 | Sham comparator | Radiation: 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 |
Sex: All, ages: 7 Years to 65 Years, accepts healthy volunteers
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