The Effect of Non-Invasive Vagal Nerve Stimulation Combined With Self-Managed Therapy in Individuals With Myogenic Temporomandibular Dysfunction

May 28, 2026 updated by: Ümit YÜZBAŞIOĞLU, Toros University

The Effect of Non-Invasive Vagal Nerve Stimulation Combined With Self-Managed Therapy in Individuals With Myogenic Temporomandibular Dysfunction: A Double-Blind, Randomised, Placebo-Controlled, Clinical Study

The aim of our study is to determine the benefit of non-invasive Vagal Nerve Stimulation in combination with self-administered therapy on the symptoms associated with jaw joint dysfunction in individuals with jaw joint dysfunction.

If you agree to participate in the study, you will fill out a form containing your information such as age, height, body weight. Then, Visual Analog Scale (VAS) and Central Sensitisation Scale will be used to assess the severity of jaw and neck joint pain. The 8-question Jaw Function Restriction Scale will be used to assess the limitation of jaw function.

An algometer will be used to evaluate the pressure-pain threshold, and Therabite range of motion scale will be used to evaluate the range of motion of the jaw joint. One photograph will be taken from the side profile to evaluate the head-neck posture, this photograph will be used for craniocervical angle measurement and will not be shared elsewhere. Myotonmetry will be used to evaluate muscle mechanical properties and non-invasive superficial electromyography (yEMG) will be used to evaluate muscle activation.

The treatments to be applied within the scope of the study will be carried out 3 days a week and the evaluation sessions will last 30 minutes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Mersin, Turkey (Türkiye), 33140
        • Toros University 45 Evler Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • between the ages of 18-45,
  • Diagnosed with myogenic TMDs according to TMD-DC Axis I and II criteria,
  • Pain intensity of 3 or more during rest and/or chewing according to the Visual Analogue Scale,
  • Volunteered to participate in the study and signed the informed consent form,
  • Individuals who do not have communication difficulties and whose native language is Turkish will be included in the study.

Exclusion Criteria:

  • Diagnosed with arthrogenic or mixed type TMDs,
  • Severe psychiatric illness such as schizophrenia,
  • Previous vagal nerve stimulation or history of vagotomy,
  • Have extensive joint damage affecting the jaw, head, neck and shoulder areas, have a history of major trauma, fracture or surgery to these body parts, or are undergoing radiotherapy,
  • Diagnosed with cervical disc herniation, cervical radiculopathy or cervical myelopathy,
  • History of cardiac disease and being treated for cardiac problems,
  • Active implant users such as pacemakers, defibrillators, neurostimulators, cochlear implants and ventricular shunts,
  • Failure to understand the study protocol
  • Have a history of progressive neurological diseases (such as Parkinson's disease, MS, ALS, epilepsy, Alzheimer's disease)
  • Acute tinnitus
  • Skin problems such as dermatitis, infection, psoriasis, urticaria, acne or eczema at the stimulation site,
  • Has any anatomical abnormality that prevents successful placement of the ear electrode,
  • and reporting acute tinnitus,
  • Pregnant subjects will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Self-Management Therapy Group
The self-administered therapy programme will consist of prevention of parafunctional activities, information about sleep hygiene and home exercise programmes, the effectiveness of which has been reported in the literature and is in line with the International Delphi Guidelines. Home exercises will start with 2 times a day, 8 repetitions and progress will be made weekly according to the patient's condition.
Other: Self-Management Therapy
Participants in this group will receive self management therapy. The self-administered therapy programme will consist of prevention of parafunctional activities, information about sleep hygiene and home exercise programmes, the effectiveness of which has been reported in the literature and is in line with the International Delphi Guidelines. Home exercises will start with 2 times a day, 8 repetitions and progress will be made weekly according to the patient's condition.
Placebo Comparator: Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation
For Placebo Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, the technique will be similar to active stimulation. The VaguStim device will be set to 0 Hz by the practitioner, indicating that no actual stimulation is being delivered. Patients will be told that they will not be able to feel the current due to its lower intensity during the intervention, without explaining the true nature of the placebo stimulation.
Other: Self-Management Therapy
Participants in this group will receive self management therapy. The self-administered therapy programme will consist of prevention of parafunctional activities, information about sleep hygiene and home exercise programmes, the effectiveness of which has been reported in the literature and is in line with the International Delphi Guidelines. Home exercises will start with 2 times a day, 8 repetitions and progress will be made weekly according to the patient's condition.
Device: Placebo Non-Invasive Vagal Nerve Stimulation
Participants in this group will receive self managemenet therapy and placebo vagal nerve stimulation. For Placebo Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, the technique will be similar to active stimulation. The VaguStim device will be set to 0 Hz by the practitioner, indicating that no actual stimulation is being delivered. Patients will be told that they will not be able to feel the current due to its lower intensity during the intervention, without explaining the true nature of the placebo stimulation.
Experimental: Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation

Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, CE certified (CE No: 2460) non-invasive stimulation device will be applied with. The application will be performed with 3 different sized electrodes (small, medium, large) specially designed according to the size of the inner ear. The stimulation will be delivered bilaterally from the symba concha and tragus regions innervated by the auricular branch of the n.vagus, which guarantees effective and targeted vagal modulation. With reference to the studies in the literature; VaguStim application frequency will be 25 Hz, pulse width 250 µs, current level 0.5 mA with biphasic waveform.

The treatment will continue 3 days a week for a total of 6 weeks, with each session lasting 20 minutes.
Other: Self-Management Therapy
Participants in this group will receive self management therapy. The self-administered therapy programme will consist of prevention of parafunctional activities, information about sleep hygiene and home exercise programmes, the effectiveness of which has been reported in the literature and is in line with the International Delphi Guidelines. Home exercises will start with 2 times a day, 8 repetitions and progress will be made weekly according to the patient's condition.
Device: Non-Invasive Vagal Nerve Stimulation
Participants will receive Non-Invasive Vagal Nerve Stimulation and self management therapy. : Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, CE certified (CE No: 2460) non-invasive stimulation device will be applied with. The application will be performed with 3 different sized electrodes (small, medium, large) specially designed according to the size of the inner ear. The stimulation will be delivered bilaterally from the symba concha and tragus regions innervated by the auricular branch of the n.vagus, which guarantees effective and targeted vagal modulation. With reference to the studies in the literature; VaguStim application frequency will be 25 Hz, pulse width 250 µs, current level 0.5 mA with biphasic waveform. The treatment will continue 3 days a week for a total of 6 weeks, with each session lasting 20 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Jaw and neck joint pain intensity will be assessed using the Visual Analogue Scale (VAS),which is reported to be valid and reliable.The individuals included in the study will be asked to indicate the jaw and neck joint pain intensity they have experienced at rest and during chewing in the last 1 week on a 100 mm long line positioned vertically.The marked points will be measured and recorded in millimetres.An increase in VAS indicates pain of higher intensity Pressure-pain threshold measurement will be performed using a digital algometer.Before starting the tests, the individuals will be informed about the test and one trial session will be performed. The tests will be performed using a 1 cm2 headgear with a 1 kg/cm2 increase in pressure intensity every second and the participants will be asked to tell the evaluator the point at which the pressure to be applied turns into mild pain. The average of three consecutive tests performed at 30 s intervals will be taken and recorded in kg/cm2.
First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of Temporomandibular Joint Range of Motion
Time Frame: First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
The TheraBite® Range of Motion Scale (TheraBite ®, Platon Medikal Ltd., United Kingdom) will be used to assess the range of motion of the participants' jaw joint. TheraBite is a scale with high intra-observer reliability that is frequently used in the literature for the assessment of jaw joint range of motion and is accepted as the standard for clinical use. Participants will be placed supine on a therapy table in an examination room and asked to open their mouths as far as they can and the range of motion will be recorded in millimetres (mm). The measurements will be repeated three times and the average of the three measurements will be taken as reference.Higher values obtained from this scale represent an increase in the range of motion of the mouth.
First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Craniocervical Posture Assessment
Time Frame: First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
The craniocervical postures of the individuals included in the study will be evaluated using photogrammetry method based on angle calculation on photographs. For the measurement, the seventh cervical vertebral processes and ear tragus of the individuals will be determined as reference points and these points will be clearly marked before photographing. After the marking is completed, the individual will be asked to perform neck flexion and extension repeatedly to ensure neutral head position in the standing position, and then photographed with a mobile phone camera placed on a tripod 1.5 metres away from the left side of the individual. A craniocervical angle of less than 50 degrees means a forward head posture.
First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Muscle Activity Measurements
Time Frame: First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
In the study, a 4-channel superficial EMG (yEMG) device (Ultium EMG Sensor, Noraxon, USA), which is reported to be valid and reliable, will be used to evaluate the activation of masticatory muscles (masseter and temporalis).
First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Muscle Stiffness
Time Frame: First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Stiffness [N/m], is a biomechanical property of a muscle, provides information about the resistance of the tissue to an external force or contraction. stiffness will be measured using a myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia), which has been reported to be valid and reliable. Assessments will be conducted in study, masseter, upper trapezius, tibialis anterior muscles.The measurement will be repeated 3 times and the arithmetic mean of the measurements will be recorded.
First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Logarithmic Decrease
Time Frame: First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment
Logarithmic decrease (D) gives information about the elasticity of the evaluated tissue. Logarithmic decrease will be measured using a myotonometer (MyotonPRO, Myoton AS, Tallinn, Estonia), which has been reported to be valid and reliable.Assessments will be conducted in study, masseter, upper trapezius, tibialis anterior muscles.The measurement will be repeated 3 times and the arithmetic mean of the measurements will be recorded.
First Interview: Initial Assessment/ End of Week 2: Second Evaluation /End of Week 6: Third Evaluation /At the end of Week 12: Fourth and final assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Toros University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Aydan AYTAR, PhD, University of Health Sciences (Ankara-Turkey)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU-FTR-UY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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