NCT06802445

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Toros University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Temporomandibular Disorders (TMD)

Interventions

Type	Name	Description
OTHER	Self-Management Therapy	Participants in this group will receive self management therapy. 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.
DEVICE	Placebo Non-Invasive Vagal Nerve Stimulation	Participants in this group will receive self managemenet therapy and placebo vagal nerve stimulation. 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.
DEVICE	Non-Invasive Vagal Nerve Stimulation	Participants will receive Non-Invasive Vagal Nerve Stimulation and self management therapy. : 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.

Timeline

• Start date: 2025-02-08
• Primary completion: 2026-01-22
• Completion: 2026-02-03
• First posted: 2025-01-31
• Last updated: 2025-09-11

Locations

1 site across 1 country: Turkey (Türkiye)