Effectiveness of Photobiomodulation for Myofascial Pain in Temporomandibular Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal University of Rio Grande do Sul
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation Therapy
DevicePhotobiomodulation 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 Exercises
BehavioralA 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 Therapy
DeviceSham 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.
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: Photobiomodulation TherapyExperimental treatment 1 intervention
Group B: Photobiomodulation Therapy + ExercisesExperimental treatment 2 interventions
Group C: Sham Photobiomodulation Therapy + ExercisesSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.Secondary outcomes
1
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.
Time frame
Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.2
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.
Time frame
Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.3
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.
Time frame
Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.4
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.
Time frame
Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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