Temporomandibular Disorders (TMD)NCT06802445
The Effect of Non-Invasive Vagal Nerve Stimulation Combined With Self-Managed Therapy in Individuals With Myogenic Temporomandibular Dysfunction
A study testing Self-Management Therapy and Non-Invasive Vagal Nerve Stimulation in people with Temporomandibular Disorders (TMD), run by Toros University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporomandibular Disorders (TMD)
- What is being tested?
- Self-Management Therapy and Non-Invasive Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Toros University 45 Evler Campus
Mersin, 33140
About this study
Official title: 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.
Read more
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.
- Conditions
- Temporomandibular Disorders (TMD)
- Being tested
- Self-Management Therapy, Placebo Non-Invasive Vagal Nerve Stimulation, Non-Invasive Vagal Nerve Stimulation
- Keywords
- myogenic temporomandibular disorders, transcutaneous vagal nerve stimulation, pain, self-menaged therapy, posture, muscle activation, muscle stiffness
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management TherapyOther
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 Non-Invasive Vagal Nerve StimulationDevice
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.
Non-Invasive Vagal Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Management Therapy Group | Active comparator | 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. Receives: Other: Self-Management Therapy |
| Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation | Placebo comparator | 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. Receives: Other: Self-Management Therapy; Device: Placebo Non-Invasive Vagal Nerve Stimulation |
| Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation | Experimental | 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. Receives: Other: Self-Management Therapy; Device: Non-Invasive Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
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.
Measured: 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 outcomes (5)
Evaluation of Temporomandibular Joint Range of Motion
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Oct 2024
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "A Double-Blind, Randomised, Placebo-Controlled, Clinical Study" Within the scope of this single-centre, prospective, double-blind, parallel group, placebo-controlled study design, participants will be randomised to 3 groups via a web-based randomisation website.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümit YÜZBAŞIOĞLU, Toros University
- Investigators
- Aydan AYTAR, PhD, Study chair, University of Health Sciences (Ankara-Turkey)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802445
- Sponsor's protocol ID
- TU-FTR-UY-01
- Status last verified
- May 2026
- First submitted
- 19 Jan 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06802445
- Acronym / sponsor ID
- TU-FTR-UY-01
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- myogenic temporomandibular disorders, transcutaneous vagal nerve stimulation, pain, self-menaged therapy, posture, muscle activation, muscle stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- "A Double-Blind, Randomised, Placebo-Controlled, Clinical Study" Within the scope of this single-centre, prospective, double-blind, parallel group, placebo-controlled study design, participants will be randomised to 3 groups via a web-based randomisation website.
| Arm | Type | Receives |
|---|---|---|
| Self-Management Therapy Group | Active comparator | Other: Self-Management TherapyThe 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. |
| Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation | Placebo comparator | Other: Self-Management Therapy, Device: Placebo Non-Invasive Vagal Nerve StimulationFor 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. |
| Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation | Experimental | Other: Self-Management Therapy, Device: Non-Invasive Vagal Nerve StimulationNon-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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management TherapyParticipants 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. | Other | Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation, Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation, Self-Management Therapy Group |
| Placebo Non-Invasive Vagal Nerve StimulationParticipants 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. | Device | Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation |
| Non-Invasive Vagal Nerve StimulationParticipants 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. | Device | Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation |
Primary outcome
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorders (TMD)
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aydan AYTAR, PhD study chair
University of Health Sciences (Ankara-Turkey)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Therapy and Non-Invasive Vagal Nerve Stimulation in people with Temporomandibular Disorders (TMD), run by Toros University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.