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

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 performed before treatment and 5 weeks after the 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Temporomandibular Joint Disease
• Intervention / Treatment: Procedure: Multimodal physiotherapy program; Procedure: EMG-Biofeedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Merve TAT, Assistant Professor; Phone Number: +905052431112; Email: aysemervetat@yyu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Tuşba
    • Van, Tuşba, Turkey (Türkiye), 65080
      • Van Yuzuncu Yıl University
      • Contact: Ayşe Merve TAT, Assistant Professor; Phone Number: +905052431112; Email: aysemervetat@yyu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Multimodal physiotherapy program	Procedure: Multimodal physiotherapy program; 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).
Experimental: Intervention Group; A multimodal physiotherapy program and muscle relaxation training with EMG-Biofeedback	Procedure: Multimodal physiotherapy program; 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).; Procedure: EMG-Biofeedback; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 5 weeks
Pressure pain threshold	Pressure pain threshold on temporomandibular joint will be assessed using Digital Algometer	From enrollment to the end of treatment at 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 5 weeks
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.	From enrollment to the end of treatment at 5 weeks
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.	From enrollment to the end of treatment at 5 weeks
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.	From enrollment to the end of treatment at 5 weeks
Neck Functionality	Neck Functionality will be assessed with Neck Disability Index.	From enrollment to the end of treatment at 5 weeks
Sleep quality	Sleep quality will be assessed using the Pittsburg Sleep Quality Index.	From enrollment to the end of treatment at 5 weeks
Patient satisfaction	Patient satisfaction will be assessed with Visual Analog Scale.	From enrollment to the end of treatment at 5 weeks

Collaborators and Investigators

• Sponsor: Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biofeedback; Muscle Relaxation; Exercise Therapy; Manual Therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders
• Other Study ID Numbers: YuzuncuYil 2026- TMJ 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No