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

Launched by TOROS UNIVERSITY · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment that combines non-invasive Vagal Nerve Stimulation with self-managed therapy to help people with Temporomandibular Disorders (TMD), which can cause pain and dysfunction in the jaw. The goal is to see if these methods can improve symptoms like jaw and neck pain, and to better understand how they affect jaw function.

To participate, you need to be between 18 and 45 years old and diagnosed with a specific type of TMD that causes pain, rated at a level of 3 or higher on a pain scale. If you join the study, you will complete some questionnaires about your pain and jaw function and undergo several assessments, including measuring your jaw movement and muscle activity. The treatment sessions will occur three times a week and last about 30 minutes each. It's important to note that certain health conditions or previous treatments may exclude you from participating, so be sure to discuss your medical history with the study team.

Gender

ALL

Eligibility 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