Non-invasive vagal nerve stimulation with self-managed therapy for jaw muscle TMD
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
This test sees if adding painless, non-invasive vagal nerve stimulation to a self-managed therapy program reduces jaw and neck pain and improves function in adults with muscle-related TMD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Toros University Academic / other |
| Locations | 1 site (Mersin) |
| Trial ID | NCT06802445 on ClinicalTrials.gov |
What this trial studies
Adults diagnosed with myogenic temporomandibular disorder will receive self-managed therapy alone, self-managed therapy with placebo stimulation, or self-managed therapy with active transcutaneous vagal nerve stimulation. Pain, central sensitization, jaw function, pressure-pain threshold, jaw range of motion, head‑neck posture (craniocervical angle), and muscle mechanical properties will be measured using standardized scales, algometry, Therabite ROM, photography, and myotonometry. Eligible participants are 18–45 years old with a myogenic TMD diagnosis and baseline pain of 3/10 or greater. Outcomes collected before and after the intervention will be compared between groups to see if the active stimulation provides added benefit.
Who should consider this trial
Good fit: Adults aged 18–45 with diagnosed myogenic TMD, baseline pain of 3/10 or higher, able to read Turkish, and willing to attend in-person assessments are the intended participants.
Not a fit: People with arthrogenic or mixed TMD, major jaw/neck trauma or surgery, cervical radiculopathy or myelopathy, implanted cardiac devices, prior vagal nerve surgery, or active serious psychiatric or cardiac disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could reduce pain and improve jaw movement and posture using a non-invasive adjunct to standard self-care.
How similar studies have performed: Transcutaneous vagal nerve stimulation has shown some analgesic effects in other pain conditions, but its use combined with self-managed therapy for myogenic TMD is novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mersin
- Toros University 45 Evler Campus — Mersin, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ümit YÜZBAŞIOĞLU, MSc
- Email: umit.yuzbasioglu@toros.edu.tr
- Phone: +90 532 255 75 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.