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
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 11, 2026
CompletedStudy Start
First participant enrolled
June 18, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2026
Study Completion
Last participant's last visit for all outcomes
December 15, 2026
June 9, 2026
June 1, 2026
6 months
May 4, 2026
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 4 and 16 weeks
Pressure pain threshold
Pressure pain threshold on temporomandibular joint will be assessed using Digital Algometer
From enrollment to the end of treatment at 4 and 16 weeks
Secondary Outcomes (7)
Maximum mouth opening
From enrollment to the end of treatment at 4 and 16 weeks
Temporomandibular Joint Functionality
From enrollment to the end of treatment at 4 and 16 weeks
Health-Related Quality of Life
From enrollment to the end of treatment at 4 and 16 weeks
Cervical Range of Motion
From enrollment to the end of treatment at 4 and 16 weeks
Neck Functionality
From enrollment to the end of treatment at 4 and 16 weeks
- +2 more secondary outcomes
Study Arms (2)
Control Group
ACTIVE COMPARATORMultimodal physiotherapy program
Intervention Group
EXPERIMENTALA multimodal physiotherapy program and muscle relaxation training with EMG-Biofeedback
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Van Yüzüncü Yıl University
Van, Tuşba, 65080, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 4, 2026
First Posted
May 11, 2026
Study Start (Estimated)
June 18, 2026
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
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.