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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYuzuncu Yil University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal physiotherapy program

    Procedure/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-Biofeedback

    Procedure/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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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

Time frame
From enrollment to the end of treatment at 4 and 16 weeks

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
From enrollment to the end of treatment at 4 and 16 weeks

Other outcomes

Sponsors and contacts

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