CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Auricular Non-Invazive Vagus Nerve Stimulation + Traditional Rehabilitation Program for TMD +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05500716
NCT05500716N/ACompleted

The Effect of Application of Vagus Nerve Stimulation on the Treatment Efficiency in Temporomandibular Joint Dysfunction Caused by Myofascial Pain Syndrome

Alper Percin·interventional·Posted Aug 15, 2022·Updated Jan 5, 2024

In Brief

A clinical study evaluating Auricular Non-Invazive Vagus Nerve Stimulation + Traditional Rehabilitation Program for TMD and Traditional Rehabilitation Program for Temporomandibular Joint Dysfunction Syndrome and Autonomic Nervous System Imbalance. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Temporomandibular joint dysfunction (TMD) is a broad clinical picture involving the TMJ and its disc, masticatory musculature, ligament tissue, and autonomic nervous system (ANS). TMD symptoms include decrease or excessive increase in joint range of motion (ROM), clicking sound or crepitation in the joint, pain around the joint or muscle group, chewing and swallowing problems. Pain caused by MPS, trigger point, fatigue, limitation of ROM, and ANS dysfunction cause TMD. With the inclusion of habits such as clenching and bruxism, pain, spasm and disability develop in the chewing muscles. Exposure to repeated trauma and excessive use of chewing muscles may cause the formation of tight bands and trigger points, which are characterized by MPS. When the relationship between TMD and ANS was examined, it was observed that increased sympathetic activity and decreased parasympathetic activity were effective in the severity of TMD symptoms. Auricular vagus nerve stimulation is a peripheral, non-pharmacological and non-invasive neuromodulation technique that modifies signal processing in the CNS, activates reflex circuits, exploits brain plasticity for different therapeutic purposes, thereby affecting very different areas of the brain. Non-invasive or transcutaneous Vagus Nerve Stimulation delivery systems provide stimulation in the auricular branch of the vagus nerve in the outer ear, thus eliminating the need for surgical implantation. The aim of our study is to reveal the extent to which Auricular Vagus Nerve Stimulation, applied in addition to the conventional rehabilitation program, affects the results of the treatment by stimulating the parasympathetic nervous system in patients with Temporomandibular Joint Dysfunction caused by Myofascial Pain Syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 15, 2022
Enrollment StartAug 15, 2022
Primary CompletionOct 15, 2023
Study CompletionNov 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 3.9 years ago

Interventions

Auricular Non-Invazive Vagus Nerve Stimulation + Traditional Rehabilitation Program for TMDother

In this application, vagus nerve stimulation is applied to the patients in addition to the traditional rehabilitation program. In our research, vagal nerve stimulation will be applied with the "Vagustim" Device and all applications will be applied at a frequency of 10 Hz, a pulse amplitude of 300 microseconds and for 20 minutes.

Traditional Rehabilitation Programother

This intervention includes: Deep Friction Massage, Myofascial Trigger Point Compression Therapy, Temporomandibular Joint Mobilization, Rocabado Exercises, Muscle-Energy Techniques.