Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT06802445

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

Led by Toros University · Updated on 2025-09-11

48

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 18 and 45
  • Diagnosed with myogenic temporomandibular disorders (TMD) according to TMD-DC Axis I and II criteria
  • Pain intensity of 3 or more at rest and/or during chewing measured by Visual Analogue Scale
  • Volunteered to participate and signed the informed consent form
  • Able to communicate and native Turkish speaker
Not Eligible

You will not qualify if you...

  • Diagnosed with arthrogenic or mixed type temporomandibular disorders
  • Severe psychiatric illnesses like schizophrenia
  • Previous vagal nerve stimulation or history of vagotomy
  • Extensive joint damage or history of major trauma, fracture, surgery, or radiotherapy involving jaw, head, neck, or shoulder
  • Diagnosed with cervical disc herniation, radiculopathy, or myelopathy
  • History of cardiac disease or current cardiac treatment
  • Use of active implants such as pacemakers, defibrillators, neurostimulators, cochlear implants, or ventricular shunts
  • Unable to understand the study protocol
  • History of progressive neurological diseases including Parkinson's, MS, ALS, epilepsy, or Alzheimer's
  • Acute tinnitus
  • Skin problems (dermatitis, infection, psoriasis, urticaria, acne, eczema) at stimulation site
  • Anatomical abnormalities preventing correct ear electrode placement
  • Pregnant subjects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Toros University 45 Evler Campus

Mersin, Turkey (Türkiye), 33140

Actively Recruiting

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Research Team

Ü

Ümit YÜZBAŞIOĞLU, MSc

CONTACT

E

Ece EKİCİ, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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