Effectiveness of Photobiomodulation for Myofascial Pain in Temporomandibular Disorders

NCT07460895 | Not Yet Recruiting

• 2 other identifiers: PBM and TMD408830/2024-7
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Photobiomodulation; Temporomandibular Disorder (TMD); Myofacial Pain; Pain Management

Keywords

Photobiomodulation; Myofascial Pain; Temporomandibular Disorder; Pain Management

Outcome Measures

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.

  Baseline, throughout the 12 intervention sessions over 4 weeks, and at 1-month and 3-month follow-up assessments.

Secondary Outcomes (5)

• Muscle Pain

  Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.

• Chronic Pain

  Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), at 1-month and 3-month follow-up assessments.

• Mandibular Function

  Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.

• Depressive Symptoms

  Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.

• Anxiety Symptoms

  Baseline, at week 4 (after the 12th session of photobiomodulation or placebo), and at 1-month and 3-month follow-up assessments.

Study Arms (3)

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.

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.

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.

Behavioral: Therapeutic Exercises; Device: Sham Photobiomodulation Therapy

Interventions

Photobiomodulation Therapy DEVICE

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.

Photobiomodulation Therapy; Photobiomodulation Therapy + Exercises

Therapeutic Exercises BEHAVIORAL

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.

Photobiomodulation Therapy + Exercises; Sham Photobiomodulation Therapy + Exercises

Sham Photobiomodulation Therapy DEVICE

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.

Sham Photobiomodulation Therapy + Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain; Agnosia

Interventions

Low-Level Light Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Officials

• Manoela Domingues Martins, DDS, MSc, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoela Domingues Martins, DDS, MSc, PhD

CONTACT

5551 99608802; manomartins@gmail.com

Júlia Breda Soares, DDS, MSc

CONTACT

5554 96077474; julia.breda.soares@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 10, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share