NCT07577687

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 18, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

May 4, 2026

Last Update Submit

June 4, 2026

Conditions

Keywords

Muscle RelaxationBiofeedbackExercise TherapyManual Therapy

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 COMPARATOR

Multimodal physiotherapy program

Procedure: Multimodal physiotherapy program

Intervention Group

EXPERIMENTAL

A multimodal physiotherapy program and muscle relaxation training with EMG-Biofeedback

Procedure: Multimodal physiotherapy programProcedure: 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).

Control GroupIntervention Group

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.

Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Central Study Contacts

Ayşe Merve TAT, Assistant Professor

CONTACT

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.

Locations