PhotobiomodulationNCT07460895
Effectiveness of Photobiomodulation for Myofascial Pain in Temporomandibular Disorders
A study testing Photobiomodulation Therapy and Therapeutic Exercises in people with Photobiomodulation and Temporomandibular Disorder (TMD), run by Federal University of Rio Grande do Sul.
Trial summary
This randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photobiomodulation, Temporomandibular Disorder (TMD), Myofacial Pain
- What is being tested?
- Photobiomodulation Therapy and Therapeutic Exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with myofascial TMD (ICD-9 729.1; ICD-10 M79.1) diagnosed according to the DC/TMD criteria;
- Participants aged 18 years or older;
- Individuals able to communicate, read, write, and provide written informed consent in Portuguese.
Who cannot join
- Patients with a history of autoimmune connective tissue diseases, such as rheumatoid arthritis, psoriatic arthritis, scleroderma, or systemic lupus erythematosus;
- History of malignancy in the head and neck region within the past 2 years (except basal cell carcinoma) who have undergone head and neck radiation therapy and/or surgery affecting facial muscles;
- Patients who have undergone temporomandibular joint surgery or orthognathic surgery;
- Pregnant or breastfeeding women;
- Patients with poorly adapted prostheses and/or prostheses associated with inadequate increase or decrease of the vertical dimension;
- Patients with a history of tardive dyskinesia or oromandibular/cervical dystonia; -Patients with maximum mouth opening less than 35 mm;
Show all 9Show fewer
- Patients using systemic medications with a potential effect on pain at the time of screening will not be included in the study, including analgesics, anti-inflammatory drugs, muscle relaxants, corticosteroids, or other medications with analgesic and/or anti-inflammatory effects.
- If a participant initiates the use of any such medication during the follow-up period, the participant will be excluded from the study.
- Patients receiving oral and/or intravenous corticosteroid bolus therapy at doses > 1 mg/kg within the past 3 months, and those receiving biologic agents within 1 month or five times the drug half-life, whichever is longer; Individuals with mental or psychological conditions that may prevent participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Photobiomodulation in the Management of Myofascial Pain: A Randomized and Blinded Clinical Trial
This randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Participants will be allocated into three groups: PBM alone, PBM combined with exercises, or placebo PBM combined with exercises. The intervention consists of 12 treatment sessions. Outcomes related to pain intensity, mandibular function, and clinical measures will be assessed over time. The study seeks to investigate whether PBM provides additional benefits in pain reduction and functional improvement in individuals with myofascial TMD.
Read the detailed description
This randomized, assessor-blinded, parallel-group clinical trial aims to evaluate the effects of photobiomodulation therapy (PBM) on clinical and psychosocial outcomes in adults with myofascial temporomandibular disorders (TMD). Myofascial pain is one of the most prevalent subtypes of TMD and is frequently associated with muscle tenderness, functional limitation, chronic pain, and psychological distress. Conservative and non-invasive therapies are considered first-line approaches, and PBM has emerged as a promising modality due to its potential anti-inflammatory and analgesic effects.
The primary objective of this study is to analyze the impact of PBM on muscle pain intensity, assessed using the Visual Analog Scale (VAS). Secondary objectives include evaluating specific muscle pain through DC/TMD clinical examination, chronic pain severity using the Graded Chronic Pain Scale version 2 (GCS v2), mandibular functional limitation using the Jaw Functional Limitation Scale (JFLS-20), quality of life assessed using the Patient Health Questionnaire (PHQ-9), and anxiety symptoms using the Generalized Anxiety Disorder scale (GAD-7).
A total of 120 adult undergraduate and graduate students from the Federal University of Rio Grande do Sul (UFRGS) will be recruited through institutional dissemination and interest forms. Eligible participants must be 18 years or older, diagnosed with myofascial TMD according to DC/TMD criteria, and able to attend all treatment sessions and follow-up assessments. Individuals with systemic musculoskeletal conditions, recent head and neck malignancy, previous temporomandibular joint surgery, pregnancy or lactation, severe psychiatric conditions that prevent participation, or ongoing treatments that may interfere with outcomes will be excluded.
Participants will undergo baseline assessment and will be randomly allocated (1:1:1) into three groups: (1) PBM alone; (2) PBM combined with therapeutic exercises; or (3) placebo PBM combined with therapeutic exercises. PBM will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally at standardized anatomical points over the temporomandibular joint and masticatory muscles. The intervention will consist of 12 treatment sessions performed three times per week over four weeks. Participants allocated to the exercise groups will perform daily home-based therapeutic exercises focused on muscle relaxation, joint mobility, and functional improvement, with adherence monitoring throughout the study.
Randomization will be performed by an independent investigator using a centralized allocation system with concealment procedures. Participants will remain blinded regarding active or placebo laser application, and outcome assessors and statisticians will remain blinded to group allocation to minimize performance and detection bias. Due to the nature of the interventions, the therapist delivering PBM will not be blinded.
Clinical and psychosocial outcomes will be assessed at baseline, after completion of the 12 treatment sessions, and at 1-month and 3-month follow-up visits. Adverse events and rescue medication use will be monitored throughout the study period. Data will be managed using Research Electronic Data Capture (REDCap®) and analyzed under the intention-to-treat principle using mixed-effects statistical models to evaluate changes over time and between groups.
The study aims to provide high-quality evidence regarding the effectiveness of PBM alone or combined with therapeutic exercises in reducing pain, improving mandibular function, and positively influencing psychological outcomes in individuals with myofascial TMD, contributing to evidence-based conservative management strategies.
- Being tested
- Photobiomodulation Therapy, Therapeutic Exercises, Sham Photobiomodulation Therapy
- Keywords
- Photobiomodulation, Myofascial Pain, Temporomandibular Disorder, Pain Management
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation TherapyDevice
Photobiomodulation therapy (PBM) will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention is performed using a non-thermal protocol, delivering 20 J per application point. Irradiation is applied bilaterally at predefined sites, including the masseter muscle, temporomandibular joint region, and temporal muscle. The procedure is performed by trained operators according to a standardized protocol to ensure consistency across sessions. This device-based intervention aims to modulate pain, improve microcirculation, and promote functional recovery in individuals with myofascial temporomandibular disorders.
Therapeutic ExercisesBehavioural
A standardized home-based therapeutic exercise program will be performed once daily throughout the intervention period. The protocol includes self-massage of the masseter and temporal muscles using circular fingertip movements with light to moderate pressure, cheek inflation exercises alternating sides, and controlled mandibular opening and closing movements with the tongue positioned against the palate. Written instructions and in-person guidance will be provided, along with a demonstration video to support correct execution. Participants will receive daily reminder messages, and adherence will be monitored through individual exercise logs completed throughout the study.
Sham Photobiomodulation TherapyDevice
Sham photobiomodulation therapy will be delivered using a Gemini EVO dual-wavelength diode laser device (810 + 980 nm) positioned and operated identically to the active PBM protocol. The device will be applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles; however, no therapeutic energy will be emitted, ensuring a placebo condition while maintaining participant blinding. The simulated intervention will follow the same number of sessions, duration, and procedures as the active PBM protocol.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Therapy | Experimental | Participants assigned to this arm will receive photobiomodulation therapy using a dual-wavelength diode laser (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention consists of 12 treatment sessions conducted over four weeks. Receives: Device: Photobiomodulation Therapy |
| Photobiomodulation Therapy + Exercises | Experimental | Participants assigned to this arm will receive extraoral photobiomodulation therapy (PBM) using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), delivering 20 J per application point over standardized anatomical points of the temporomandibular joint and masticatory muscles (six points per side). The intervention consists of 12 treatment sessions conducted over four weeks.
Additionally, participants will perform a standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided. Receives: Device: Photobiomodulation Therapy; Behavioral: Therapeutic Exercises |
| Sham Photobiomodulation Therapy + Exercises | Sham comparator | Participants assigned to this arm will receive sham extraoral photobiomodulation therapy using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), applied over standardized anatomical points of the temporomandibular joint and masticatory muscles with identical procedures to the active protocol, but without therapeutic energy emission to maintain participant blinding. The simulated intervention consists of 12 sessions conducted over four weeks.
Additionally, participants will perform the same standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided. Receives: Behavioral: Therapeutic Exercises; Device: Sham Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Myofascial Pain Intensity
Myofascial pain intensity will be assessed using the Visual Analog Scale for Pain, ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable," with higher scores representing worse pain.
Participants will rate (1) worst pain experienced in the previous 24 hours and (2) pain evoked by standardized clinical palpation.
Palpation will be performed bilaterally on the masseter and temporalis muscles and on the temporomandibular joint region, using controlled and standardized pressure applied for approximately 2 seconds per palpation point by a trained examiner.
Measured: Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.
Secondary outcomes (5)
Muscle Pain
Muscle and temporomandibular joint pain will be assessed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), based on a standardized and calibrated clinical examination performed by a trained examiner. The assessment includes bilateral palpation of the masticatory muscles (temporalis and masseter) and the temporomandibular joint region, using standardized pressure according to DC/TMD guidelines. Pain response is recorded as categorical outcomes, including presence or absence of pain, pain location (local or referred), and pain classification (familiar or non-familiar pain) during palpation. This assessment does not generate a numerical score and therefore has no minimum or maximum values, and higher or lower scores do not apply.
Measured: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.
Chronic Pain
Chronic Pain will be assessed using the Graded Chronic Pain Scale - Version 2 (GCS v2), a validated instrument that measures chronic pain severity by considering both pain intensity and functional impact. The scale assesses pain intensity (current, average, and worst pain), the degree to which pain interferes with daily activities, work/study, and social life, as well as the number of pain-related disability days over a recent reference period. Based on these components, participants are classified into chronic pain grades (0 to IV), reflecting increasing levels of pain impact and associated disability.
Measured: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.
Mandibular Function
Mandibular Function will be evaluated using the Jaw Functional Limitation Scale - 20 items (JFLS-20), a validated questionnaire designed to assess limitations in jaw function. The scale measures the degree of difficulty experienced during jaw-related activities, including mastication, mandibular mobility, and verbal communication. Each item is rated on a numeric scale, and item scores are summed to generate a total score ranging from 0 to 200, with higher scores indicating worse mandibular functional limitation.
Measured: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) is a validated self-report instrument that evaluates depressive symptom severity and its impact on daily functioning. The questionnaire consists of nine items assessing the frequency of core depressive symptoms experienced over the previous two weeks, including mood, sleep, energy, concentration, and interest in activities. Item scores are summed to generate a total score ranging from 0 to 27, with higher scores indicating worse depressive symptom severity.
Measured: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.
Anxiety Symptoms
Anxiety symptoms will be evaluated using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7), a validated self-report instrument that measures the severity of anxiety symptoms. The questionnaire consists of seven items assessing the frequency of core anxiety symptoms experienced over the previous two weeks, including nervousness, excessive worry, difficulty relaxing, and irritability. Item scores are summed to generate a total score ranging from 0 to 21, with higher scores indicating worse anxiety symptom severity.
Measured: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotobiomodulationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoela Domingues Martins, Federal University of Rio Grande do Sul
- Investigators
- Manoela Domingues Martins, DDS, MSc, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460895
- Sponsor's protocol ID
- PBM and TMD
- Other IDs
- 408830/2024-7
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected in this study will not be made available to researchers outside the primary research group.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation in the Management of Myofascial Pain: A Randomized and Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07460895
- Acronym / sponsor ID
- PBM and TMD
- Keywords
- Photobiomodulation, Myofascial Pain, Temporomandibular Disorder, Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Mar 2026 (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 randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Participants will be allocated into three groups: PBM alone, PBM combined with exercises, or placebo PBM combined with exercises. The intervention consists of 12 treatment sessions. Outcomes related to pain intensity, mandibular function, and clinical measures will be assessed over time. The study seeks to investigate whether PBM provides additional benefits in pain reduction and functional improvement in individuals with myofascial TMD.
Detailed description
This randomized, assessor-blinded, parallel-group clinical trial aims to evaluate the effects of photobiomodulation therapy (PBM) on clinical and psychosocial outcomes in adults with myofascial temporomandibular disorders (TMD). Myofascial pain is one of the most prevalent subtypes of TMD and is frequently associated with muscle tenderness, functional limitation, chronic pain, and psychological distress. Conservative and non-invasive therapies are considered first-line approaches, and PBM has emerged as a promising modality due to its potential anti-inflammatory and analgesic effects.
The primary objective of this study is to analyze the impact of PBM on muscle pain intensity, assessed using the Visual Analog Scale (VAS). Secondary objectives include evaluating specific muscle pain through DC/TMD clinical examination, chronic pain severity using the Graded Chronic Pain Scale version 2 (GCS v2), mandibular functional limitation using the Jaw Functional Limitation Scale (JFLS-20), quality of life assessed using the Patient Health Questionnaire (PHQ-9), and anxiety symptoms using the Generalized Anxiety Disorder scale (GAD-7).
A total of 120 adult undergraduate and graduate students from the Federal University of Rio Grande do Sul (UFRGS) will be recruited through institutional dissemination and interest forms. Eligible participants must be 18 years or older, diagnosed with myofascial TMD according to DC/TMD criteria, and able to attend all treatment sessions and follow-up assessments. Individuals with systemic musculoskeletal conditions, recent head and neck malignancy, previous temporomandibular joint surgery, pregnancy or lactation, severe psychiatric conditions that prevent participation, or ongoing treatments that may interfere with outcomes will be excluded.
Participants will undergo baseline assessment and will be randomly allocated (1:1:1) into three groups: (1) PBM alone; (2) PBM combined with therapeutic exercises; or (3) placebo PBM combined with therapeutic exercises. PBM will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally at standardized anatomical points over the temporomandibular joint and masticatory muscles. The intervention will consist of 12 treatment sessions performed three times per week over four weeks. Participants allocated to the exercise groups will perform daily home-based therapeutic exercises focused on muscle relaxation, joint mobility, and functional improvement, with adherence monitoring throughout the study.
Randomization will be performed by an independent investigator using a centralized allocation system with concealment procedures. Participants will remain blinded regarding active or placebo laser application, and outcome assessors and statisticians will remain blinded to group allocation to minimize performance and detection bias. Due to the nature of the interventions, the therapist delivering PBM will not be blinded.
Clinical and psychosocial outcomes will be assessed at baseline, after completion of the 12 treatment sessions, and at 1-month and 3-month follow-up visits. Adverse events and rescue medication use will be monitored throughout the study period. Data will be managed using Research Electronic Data Capture (REDCap®) and analyzed under the intention-to-treat principle using mixed-effects statistical models to evaluate changes over time and between groups.
The study aims to provide high-quality evidence regarding the effectiveness of PBM alone or combined with therapeutic exercises in reducing pain, improving mandibular function, and positively influencing psychological outcomes in individuals with myofascial TMD, contributing to evidence-based conservative management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Therapy | Experimental | Device: Photobiomodulation TherapyParticipants assigned to this arm will receive photobiomodulation therapy using a dual-wavelength diode laser (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention consists of 12 treatment sessions conducted over four weeks. |
| Photobiomodulation Therapy + Exercises | Experimental | Device: Photobiomodulation Therapy, Behavioral: Therapeutic ExercisesParticipants assigned to this arm will receive extraoral photobiomodulation therapy (PBM) using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), delivering 20 J per application point over standardized anatomical points of the temporomandibular joint and masticatory muscles (six points per side). The intervention consists of 12 treatment sessions conducted over four weeks. Additionally, participants will perform a standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided. |
| Sham Photobiomodulation Therapy + Exercises | Sham comparator | Behavioral: Therapeutic Exercises, Device: Sham Photobiomodulation TherapyParticipants assigned to this arm will receive sham extraoral photobiomodulation therapy using a Gemini EVO dual-wavelength diode laser (810 + 980 nm), applied over standardized anatomical points of the temporomandibular joint and masticatory muscles with identical procedures to the active protocol, but without therapeutic energy emission to maintain participant blinding. The simulated intervention consists of 12 sessions conducted over four weeks. Additionally, participants will perform the same standardized home-based therapeutic exercise program once daily, including self-massage of the masseter and temporal muscles, cheek inflation exercises, and controlled mandibular opening and closing movements with tongue positioning on the palate. Written and in-person instructions, a demonstration video, daily reminders, and adherence monitoring through exercise logs will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with myofascial TMD (ICD-9 729.1; ICD-10 M79.1) diagnosed according to the DC/TMD criteria;
- Participants aged 18 years or older;
- Individuals able to communicate, read, write, and provide written informed consent in Portuguese.
Key exclusion criteria (9 listed)
- Patients with a history of autoimmune connective tissue diseases, such as rheumatoid arthritis, psoriatic arthritis, scleroderma, or systemic lupus erythematosus;
- History of malignancy in the head and neck region within the past 2 years (except basal cell carcinoma) who have undergone head and neck radiation therapy and/or surgery affecting facial muscles;
- Patients who have undergone temporomandibular joint surgery or orthognathic surgery;
- Pregnant or breastfeeding women;
- Patients with poorly adapted prostheses and/or prostheses associated with inadequate increase or decrease of the vertical dimension;
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 |
|---|---|---|
| Photobiomodulation TherapyPhotobiomodulation therapy (PBM) will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention is performed using a non-thermal protocol, delivering 20 J per application point. Irradiation is applied bilaterally at predefined sites, including the masseter muscle, temporomandibular joint region, and temporal muscle. The procedure is performed by trained operators according to a standardized protocol to ensure consistency across sessions. This device-based intervention aims to modulate pain, improve microcirculation, and promote functional recovery in individuals with myofascial temporomandibular disorders. | Device | Photobiomodulation Therapy, Photobiomodulation Therapy + Exercises |
| Therapeutic ExercisesA standardized home-based therapeutic exercise program will be performed once daily throughout the intervention period. The protocol includes self-massage of the masseter and temporal muscles using circular fingertip movements with light to moderate pressure, cheek inflation exercises alternating sides, and controlled mandibular opening and closing movements with the tongue positioned against the palate. Written instructions and in-person guidance will be provided, along with a demonstration video to support correct execution. Participants will receive daily reminder messages, and adherence will be monitored through individual exercise logs completed throughout the study. | Behavioural | Photobiomodulation Therapy + Exercises, Sham Photobiomodulation Therapy + Exercises |
| Sham Photobiomodulation TherapySham photobiomodulation therapy will be delivered using a Gemini EVO dual-wavelength diode laser device (810 + 980 nm) positioned and operated identically to the active PBM protocol. The device will be applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles; however, no therapeutic energy will be emitted, ensuring a placebo condition while maintaining participant blinding. The simulated intervention will follow the same number of sessions, duration, and procedures as the active PBM protocol. | Device | Sham Photobiomodulation Therapy + Exercises |
Primary outcome
Assessment of Myofascial Pain Intensity
Time frame: Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.
Myofascial pain intensity will be assessed using the Visual Analog Scale for Pain, ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable," with higher scores representing worse pain. Participants will rate (1) worst pain experienced in the previous 24 hours and (2) pain evoked by standardized clinical palpation. Palpation will be performed bilaterally on the masseter and temporalis muscles and on the temporomandibular joint region, using controlled and standardized pressure applied for approximately 2 seconds per palpation point by a trained examiner.
5 secondary outcomes
Muscle Pain
Time frame: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.
Chronic Pain
Time frame: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.
Mandibular Function
Time frame: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.
Depressive Symptoms
Time frame: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.
Anxiety Symptoms
Time frame: Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data collected in this study will not be made available to researchers outside the primary research group.
Related trials for Photobiomodulation
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Not yet recruiting
Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke
Stroke
Not yet recruiting
Photobiomodulation for Cancer-Related Cognitive Impairment
Cancer-related Cognitive Impairment
RecruitingPhase 2
A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant
Graft-Versus-Host Disease, GVHD
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
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.
Manoela Domingues Martins, DDS, MSc, PhD principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation Therapy and Therapeutic Exercises in people with Photobiomodulation and Temporomandibular Disorder (TMD), run by Federal University of Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manoela Domingues Martins, DDS, MSc, PhD (5551 99608802, manomartins@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Myofascial Pain Intensity (time frame: Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2026.