Clinical trial NCT06802445: The Effect of Non-Invasive Vagal Nerve Stimulation Combined with Self-Managed Therapy in Individuals with Myogenic Temporomandibular Dysfunction
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders (TMD)
Keywords: myogenic temporomandibular disorders
transcutaneous vagal nerve stimulation
pain
self-menaged therapy
posture
muscle activation
muscle stiffness
Lead sponsor: Toros University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Evaluation of Temporomandibular Joint Range of Motion
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
measure: Craniocervical Posture Assessment
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
measure: Muscle Activity Measurements
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
measure: Muscle Stiffness
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
measure: Logarithmic Decrease
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
Other outcomes:
Locations:
Study officials:
affiliation: University of Health Sciences (Ankara-Turkey)
name: Aydan AYTAR, PhD
role: STUDY_CHAIR
References: