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

NCT06802445 | Recruiting

• 1 other identifier: TU-FTR-UY-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

myogenic temporomandibular disorders; transcutaneous vagal nerve stimulation; pain; self-menaged therapy; posture; muscle activation; muscle stiffness

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Jaw and neck joint pain intensity will be assessed using the Visual Analogue Scale (VAS),which is reported to be valid and reliable.The individuals included in the study will be asked to indicate the jaw and neck joint pain intensity they have experienced at rest and during chewing in the last 1 week on a 100 mm long line positioned vertically.The marked points will be measured and recorded in millimetres.An increase in VAS indicates pain of higher intensity Pressure-pain threshold measurement will be performed using a digital algometer.Before starting the tests, the individuals will be informed about the test and one trial session will be performed. The tests will be performed using a 1 cm2 headgear with a 1 kg/cm2 increase in pressure intensity every second and the participants will be asked to tell the evaluator the point at which the pressure to be applied turns into mild pain. The average of three consecutive tests performed at 30 s intervals will be taken and recorded in kg/cm2.

  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 (5)

• Evaluation of Temporomandibular Joint Range of Motion

  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

• Craniocervical Posture Assessment

  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

• Muscle Activity Measurements

  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

• Muscle Stiffness

  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

• Logarithmic Decrease

  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

Study Arms (3)

Self-Management Therapy Group

ACTIVE COMPARATOR

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.

Other: Self-Management Therapy

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

PLACEBO COMPARATOR

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.

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

Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation

EXPERIMENTAL

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.

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

Interventions

Self-Management Therapy OTHER

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.

Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation; Self-Managed Therapy + Placebo Non-Invasive Vagal Nerve Stimulation; Self-Management Therapy Group

Placebo Non-Invasive Vagal Nerve Stimulation DEVICE

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.

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

Non-Invasive Vagal Nerve Stimulation DEVICE

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.

Self-Managed Therapy + Non-Invasive Vagal Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Toros University 45 Evler Campus

Mersin, 33140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aydan AYTAR, PhD

  University of Health Sciences (Ankara-Turkey)

  STUDY CHAIR

Central Study Contacts

Ümit YÜZBAŞIOĞLU, MSc

CONTACT

+90 532 255 75 06; umit.yuzbasioglu@toros.edu.tr

Ece EKİCİ, MSc

CONTACT

+90 530 073 38 26; ece.ekici@toros.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: "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.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 31, 2025
• Study Start: February 8, 2025
• Primary Completion: January 22, 2026
• Study Completion: February 3, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)