CompletedNot Applicable

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

Turkey (Türkiye)48 participantsStarted 2024-10-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 su…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity

Timeframe: 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

Trial details

NCT IDNCT06802445

SponsorToros University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-02

View on ClinicalTrials.gov More Temporomandibular Disorders (TMD) trials