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Temporomandibular Joint DiseaseNCT07577687

Effect of Emg-Biofeedback and Multimodal Exercise on Temporomandibular Joint Dysfunction

A study testing Multimodal physiotherapy program and EMG-Biofeedback in people with Temporomandibular Joint Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Temporomandibular joint dysfunction (TMD) is a multifactorial musculoskeletal disorder affecting the masticatory muscles, temporomandibular joint, and related structures, characterized by pain and functional limitations. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Temporomandibular Joint Disease
What is being tested?
Multimodal physiotherapy program and EMG-Biofeedback
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Jun 2026to 15 Dec 2026
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having been diagnosed with TMD, meaning having been diagnosed with Group 1 (1a: myofascial pain - 1b: referral myofascial pain) within Axis 1 according to the RDC/TMD diagnostic system.
  • Having experienced TMJ pain for at least 3 months
  • Having a sufficient cognitive level to follow simple instructions and take tests.

Who cannot join

  • Having a malignant condition in the TMJ and/or cervical spine and having undergone surgery,
  • Having neurological or psychiatric disorders, pregnancy,
  • Having a history of BTA (Botulinum toxin injection) within the last year,
  • Having received physical therapy related to TMJ less than 6 months ago,
  • Being under orthodontic treatment,
  • Having uncontrolled diabetes,
  • Having inflammatory rheumatic diseases (rheumatoid arthritis, etc.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ayşe Merve TAT, Assistant Professor contact

+905052431112

aysemervetat@yyu.edu.tr

Turkey (Türkiye)1 site
  • Van Yüzüncü Yıl University

    Van, Tuşba, 65080

    Ayşe Merve TAT, Assistant Professor, +905052431112, aysemervetat@yyu.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Emg-Biofeedback Based Relaxation Training Added to a Multimodal Exercise Program on Pain and Function in Patients With Temporomandibular Joint Dysfunction

Temporomandibular joint dysfunction (TMD) is a multifactorial musculoskeletal disorder affecting the masticatory muscles, temporomandibular joint, and related structures, characterized by pain and functional limitations. In TMD, myofascial pain is particularly prominent, leading to decreased mandibular range of motion, impaired masticatory function, and reduced quality of life. Current literature shows that conservative treatment approaches, especially multimodal physiotherapy programs, are effective in reducing TMD symptoms. However, evidence regarding the clinical effectiveness of adding EMG-Biofeedback-based relaxation training, aimed at increasing awareness of muscle activity, to multimodal treatment programs is limited. The aim of this randomized controlled trial is to investigate the effect of EMG-Biofeedback-based relaxation training, added to a multimodal exercise program, on pain levels and functional parameters in individuals diagnosed with temporomandibular joint dysfunction. Participants will be divided into two groups using a simple randomization method. The control group will receive multimodal physiotherapy consisting of manual therapy and a home exercise program, while the experimental group will receive EMG-Biofeedback-based relaxation training in addition to the same program. Assessments will be conducted before the intervention and at the end of the 4-week intervention.

Pain intensity will be measured with a Visual Analog Scale (VAS), pressure pain threshold with a digital algometer, mandibular joint range of motion with a linear scale, and cervical joint range of motion with a digital goniometer. Functional status will be assessed using the Fonseca Anamnestic Index, Neck Disability Index, and Oral Health Impact Profile-14. The obtained data will be compared using appropriate statistical analysis methods. This study is expected to provide scientific evidence regarding the clinical effectiveness of adding EMG-Biofeedback-based relaxation training to multimodal exercise programs in the conservative treatment of TMD and to contribute to filling the methodological gap mentioned in the literature.

Read the detailed description

The primary aim of this study is to investigate the effect of EMG-Biofeedback-based relaxation training, added to a multimodal exercise program, on pain levels and temporomandibular joint function in individuals diagnosed with temporomandibular joint dysfunction (TMD). It is known that in TMD, myofascial muscle pain is particularly prominent, and increased masticatory muscle activity leads to involuntary contractions and increased pain sensitivity, negatively impacting chewing, speaking, and daily living activities. This reduces the individual's functional capacity and quality of life. Therefore, this study aims to determine the contribution of adding EMG-Biofeedback-based relaxation training, which aims to increase awareness of muscle activity and promote neuromuscular relaxation, to a multimodal physiotherapy program to clinical outcomes. The primary objective of this study is to evaluate the change in pain level after the intervention. Pain will be assessed using the Visual Analog Scale (VAS), a subjective assessment method, and pressure pain threshold measurements using a digital algometer, an objective measurement method. The values obtained before and after the intervention will be compared both within and between groups. The secondary objectives of the study are to determine the changes in maximum mouth opening and mandibular range of motion, cervical joint range of motion, functional status (Fonseca Anamnestic Index), neck disability level, and quality of life related to oral health. In this context, the measurable objectives of the study are as follows:

  1. Comparison of the change in VAS scores between the experimental and control groups after five weeks of intervention.
  2. Objectively determining the change in pressure pain threshold values with a digital algometer.
  3. Evaluation of the change in mandibular and cervical range of motion using quantitative measurement methods.
  4. Statistical analysis of the changes in functional and disability scores. The determined aims and objectives are measurable, analyzable, and achievable within the thesis period. This study aims to scientifically demonstrate the contribution of EMG-Biofeedback-based relaxation training to pain control in TMD. In this study, a Demographic Information Form containing demographic information such as age, gender, occupation, and education level will be collected from the individuals participating in the study. A digital algometer will be used to objectively measure the pain threshold. Before measuring with the algometer, pressure will be applied to the pulp of the thumb of the control point. Then, force will be applied to the same point to create pain so that the individual can differentiate between pressure sensation and pain sensation, and this will be repeated three times. Afterwards, while the physiotherapist passively supports the individual's head with their other hand, pressure will be applied to 4 trigger points (TN) each in the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles, increasing the pressure by 1 kg/cm² every three seconds until the individual feels pain. The individual will be instructed to report when they feel pain while force is being applied with the device (kg/cm²), and this process will be repeated three times for each TN, and the average will be taken to determine the pain threshold values for each TN. Pain intensity will be assessed using the Visual Analog Scale (VAS). This measurement method involves measuring distance in centimeters, which is recorded as a "score." Individuals will be informed that 0 points represent "no pain" and 10 points represent "unbearable pain," and will be asked to mark the point on a horizontal plane that best expresses the intensity of their pain. The determined score will be recorded as their pain intensity. Individuals' pain will be assessed separately according to this scale while eating, yawning, and at rest. Maximum unassisted mouth opening, protrusion, and right and left lateral extrusion movements will be measured using a linear ruler. Individuals will be asked to perform these movements as much as possible without causing pain while in a seated position. The distance between the maxillary and mandibular central incisors will be measured using a millimeter ruler. Since repeated measurements reduce the standard measurement error, measurements will be recorded three times, and the average of the recorded measurements will be noted. Measurement of TMJ movements in all directions has been reported to be reliable. The Fonseca Anamnestic Index, a recommended method in research populations due to its low cost, rapid administration time, and ease of use, will be used for the detection and classification of TMD. The questionnaire consists of 10 questions offering a multifaceted approach to assess temporomandibular joint, head, and back pain in the presence of chewing habits, parafunctional behaviors, movement restrictions, joint sounds, malocclusion, and emotional stress. Participants will be asked to select one of the following options for each question: 'Yes' (10 points), 'No' (0 points), and 'Sometimes' (5 points). Based on the total score of the answers given to the questionnaire, TMD will be classified as absent, mild, moderate, or severe. Sleep quality will be assessed using the Pittsburg Sleep Quality Index (PSQI). This is a 19-item self-report scale that evaluates sleep quality and disturbance over the past month. Its validity and reliability in Turkish have been established. The scale consists of seven components: subjective sleep quality, time to fall asleep, total sleep duration, sleep efficiency, sleep disturbances, sleep medication use, and impaired daytime functioning. Each item is scored between 0 and 3: 0 (never), 1 (less than once a week), 2 (1-2 times a week), 3 (3 or more times a week). The total score ranges from 0 to 21; a higher score indicates a decrease in sleep quality. Individuals with a total score ≤5 are considered to have "good sleep quality," while those with a score >5 are considered to have "poor sleep quality." The internal consistency coefficient (Cronbach's alpha) of the Turkish form of the scale has been reported as 0.80. A digital goniometer will be used to assess Cervical Range of Motion (ROM). Cervical flexion, extension, right and left lateral flexion, and right and left rotation degrees will be recorded before and after treatment.

The Neck Disability Index (NDI) was developed by Vernon et al. in 1991, and its Turkish validity and reliability were confirmed. This questionnaire shows the extent to which neck pain affects the quality of life of the participants. The questionnaire has options from A to F for each question. Participants will be asked to mark the option closest to them. For each question, A (0 points), B (1 point), C (2 points), D (3 points), E (4 points), F (5 points). A total score will be calculated.

The Oral Health Impact Profile-14 (ASEP-14) will be used to assess the impact of oral health on quality of life. This is a questionnaire that shows the extent to which oral health affects quality of life. This scale, consisting of 14 questions in total, includes functional limitations, physical pain, psychological distress, physical, social and psychological disabilities, and impairments.

Being tested
Multimodal physiotherapy program, EMG-Biofeedback
Keywords
Muscle Relaxation, Biofeedback, Exercise Therapy, Manual Therapy
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal physiotherapy programProcedure or surgery

    A comprehensive physiotherapy program consisting of manual therapy and home exercises will be implemented for 5 weeks (multimodal exercises will be performed by a physiotherapist in the clinic one day a week, and home exercises will be performed by the patient at home on the other two days of the week).

  • EMG-BiofeedbackProcedure or surgery

    The EMG-Biofeedback program will include relaxation-based video games to reduce muscle activation. In addition to the multimodal physiotherapy program (manual therapy + home exercises), 20 minutes of relaxation training with EMG-Biofeedback will be provided. EMG-Biofeedback will be applied bilaterally to the masseter, temporalis, sternoclavicular carotid artery (SCM), and upper trapezius muscles. For each muscle, superficial electrode placement will be done on the muscle body along the direction of the muscle fibers. Electrode placement will be performed bilaterally with participants seated in a back-supported chair, feet on the floor, head and cervical region in neutral alignment, and mandible in a resting position (without teeth touching). Each muscle will receive 5 minutes of application.

Study groups in NCT07577687
Study groupRoleWhat they receive
Control GroupActive comparatorMultimodal physiotherapy program
Receives: Procedure: Multimodal physiotherapy program
Intervention GroupExperimentalA multimodal physiotherapy program and muscle relaxation training with EMG-Biofeedback
Receives: Procedure: Multimodal physiotherapy program; Procedure: EMG-Biofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temporomandibular Joint Pain Severity

    Pain severity on temporomandibular joint will be assessed with Visual Analog Scale. Individuals will be informed that pain intensity is assessed using a scale where 0 points represent "no pain" and 10 points represent "unbearable pain." They will then be asked to mark the point on a horizontal plane that best expresses the intensity of their pain. The score obtained will be recorded as their pain intensity. Individuals' pain will be assessed separately according to this scale while eating, yawning, and resting.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  2. Pressure pain threshold

    Pressure pain threshold on temporomandibular joint will be assessed using Digital Algometer

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

Secondary outcomes (7)
  1. Maximum mouth opening

    Maximum mouth opening, protrusion, and right and left lateral extrusion movements will be measured using a linear ruler. Individuals will be asked to perform these movements as much as possible without causing pain while in a seated position. The distance between the maxillary and mandibular central incisors will be measured using a millimeter ruler.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  2. Temporomandibular Joint Functionality

    The Fonseca Anamnestic Index will be used to assess TMJ functionality and disease symptoms. The questionnaire consists of 10 questions offering a comprehensive approach to evaluating temporomandibular joint, head, and back pain in the presence of chewing habits, parafunctional behaviors, movement restrictions, joint sounds, malocclusion, and emotional stress.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  3. Health-Related Quality of Life

    The Oral Health Impact Profile-14 will be used to assess the impact of oral health on quality of life. It is a questionnaire that shows the extent to which oral health affects quality of life.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  4. Cervical Range of Motion

    A digital goniometer will be used to assess cervical range of motion (ROM). Cervical flexion, extension, right and left lateral flexion, and right and left rotation degrees will be recorded before and after treatment.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  5. Neck Functionality

    Neck Functionality will be assessed with Neck Disability Index.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  6. Sleep quality

    Sleep quality will be assessed using the Pittsburg Sleep Quality Index.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

  7. Patient satisfaction

    Patient satisfaction will be assessed with Visual Analog Scale.

    Measured: From enrollment to the end of treatment at 4 and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start18 Jun 2026 (estimated)
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577687
Sponsor's protocol ID
YuzuncuYil 2026- TMJ 1
Status last verified
Jun 2026
First submitted
4 May 2026
Last updated
9 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient data may be requested from researchers after the study is completed. For ethical reasons, patient data will not be shared in an online system.

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal physiotherapy program and EMG-Biofeedback in people with Temporomandibular Joint Disease, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

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 7 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 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 Ayşe Merve TAT, Assistant Professor (+905052431112, aysemervetat@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temporomandibular Joint Pain Severity (time frame: From enrollment to the end of treatment at 4 and 16 weeks). The study lists 2 primary outcomes in all. 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 9 Jun 2026.

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