Orofacial PainNCT06065969
Photobiomodulation Dosimetry s in Patients With Orofacial Pain
A study testing Photobiomodulation in people with Orofacial Pain and Tension-Type Headache, run by University of Nove de Julho.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Orofacial Pain, Tension-Type Headache
- What is being tested?
- Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2023to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
About this study
Official title: Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain
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
- Being tested
- Photobiomodulation
- Keywords
- orofacial pain, Tension-Type Headache, photobiomodulation
- Medical subject headings
- Facial Pain, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationRadiation
660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: 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 Receives: Radiation: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache and orofacial pain
Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start10 Oct 2023 (estimated)
- Primary completion10 Dec 2023 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065969
- Sponsor's protocol ID
- PBM
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39405292
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain
- ClinicalTrials.gov ID
- NCT06065969
- Acronym / sponsor ID
- PBM
- Conditions
- Orofacial Pain, Tension-Type Headache
- Keywords
- orofacial pain, Tension-Type Headache, photobiomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Oct 2023 (estimated)
- Primary completion
- 10 Dec 2023 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local photobiomodulation | Active comparator | Radiation: PhotobiomodulationDelivering 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: Photobiomodulation660 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: PhotobiomodulationThe 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: PhotobiomodulationThe 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 |
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation660 nm and 100 mW, directing the light beam towards the radial artery region, for 10 minutes per session. | Radiation | Local photobiomodulation, Sham Vascular photobiomodulation, Vascular photobiomodulation, sham local photobiomodulation |
Primary outcome
Headache and orofacial pain
Time frame: two weeks
Headache and orofacial pain assessed using the Visual Analog Scale from zero to 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 39405292Schuler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Orofacial Pain and Tension-Type Headache, run by University of Nove de Julho.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache and orofacial pain (time frame: two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.