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

Toros University

Status: Enrolling

Conditions: Temporomandibular Disorders (TMD)

Treatments: Device: Non-Invasive Vagal Nerve Stimulation; Other: Self-Management Therapy; Device: Placebo Non-Invasive Vagal Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06802445

TU-FTR-UY-01

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Self-Management Therapy Group

Active Comparator group

Description:

The self-administered therapy programme will consist of prevention of parafunctional activities, information about sleep hygiene and home exercise programmes, the effectiveness of which has been reported in the literature and is in line with the International Delphi Guidelines. Home exercises will start with 2 times a day, 8 repetitions and progress will be made weekly according to the patient's condition.

Treatment:

Other: Self-Management Therapy

Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation

Placebo Comparator group

Description:

For Placebo Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, the technique will be similar to active stimulation. The VaguStim device will be set to 0 Hz by the practitioner, indicating that no actual stimulation is being delivered. Patients will be told that they will not be able to feel the current due to its lower intensity during the intervention, without explaining the true nature of the placebo stimulation.

Treatment:

Device: Placebo Non-Invasive Vagal Nerve Stimulation

Other: Self-Management Therapy

Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation

Experimental group

Description:

Non-Invasive Auricular Transcutaneous Vagal Nerve Stimulation, CE certified (CE No: 2460) non-invasive stimulation device will be applied with. The application will be performed with 3 different sized electrodes (small, medium, large) specially designed according to the size of the inner ear. The stimulation will be delivered bilaterally from the symba concha and tragus regions innervated by the auricular branch of the n.vagus, which guarantees effective and targeted vagal modulation. With reference to the studies in the literature; VaguStim application frequency will be 25 Hz, pulse width 250 µs, current level 0.5 mA with biphasic waveform. The treatment will continue 3 days a week for a total of 6 weeks, with each session lasting 20 minutes.

Treatment:

Other: Self-Management Therapy

Device: Non-Invasive Vagal Nerve Stimulation