The Effect of Vagus Nerve Stimulation on Temporomandibular Joint Dysfunction

NCT05500716 | Completed

• 1 other identifier: STUDYAP0001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Joint Dysfunction Syndrome; Autonomic Nervous System Imbalance

Keywords

Vagus Nerve Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  Heart rate variability (HRV) is a popular, non-invasive, physiological assessment tool among clinicians for monitoring ANS activity. Studies have shown how clinicians can examine the magnitude of autonomic modulation by examining the variability between resting heart rate (HR) and beat-beat (RR) intervals in response to training stress or psychological stress.Heart rate variability will be measured with the polar h10 device.

  Measurements will be completed between beginning-4 weeks-8 weeks-12 weeks

Secondary Outcomes (4)

• Pain and Trigger Points

  Measurements will be completed between beginning-4 weeks-8 weeks-12 weeks

• Range of motion

  Measurements will be completed between beginning-4 weeks-8 weeks-12 weeks

• Perceived Stress scale

  Measurements will be completed between beginning-4 weeks-8 weeks-12 weeks

• Neck Disability Index

  Measurements will be completed between beginning-4 weeks-8 weeks-12 weeks

Study Arms (2)

Auricular Non-Invasive Vagus Nerve Stimulation+Traditional Rehabilitation Program

EXPERIMENTAL

* Auricular Non-Invasive Vagus Nerve Stimulation * Deep Friction Massage * Myofascial Trigger Point Compression Therapy * Temporomandibular Joint Mobilization * Rocabado Exercises * Muscle-Energy Techniques

Other: Auricular Non-Invazive Vagus Nerve Stimulation + Traditional Rehabilitation Program for TMD

Traditional Rehabilitation Program

ACTIVE COMPARATOR

* Deep Friction Massage * Myofascial Trigger Point Compression Therapy * Temporomandibular Joint Mobilization * Rocabado Exercises * Muscle-Energy Techniques

Other: Traditional Rehabilitation Program

Interventions

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

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.

Auricular Non-Invasive Vagus Nerve Stimulation+Traditional Rehabilitation Program

Traditional Rehabilitation Program OTHER

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

Traditional Rehabilitation Program

Eligibility Criteria

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

You may qualify if:

• Compliant with temporomandibular disorders research/diagnosis criteria,
• Diagnosed with Myofascial Pain Syndrome,
• years and over,
• Female patients who volunteered to participate in the study and filled in the informed consent form will be included in the study.

You may not qualify if:

• History of TMJ disc dislocation,
• History of acute trauma in and around the TMJ,
• Having a history of surgical/invasive procedures on the TMJ,
• Having a neurological or psychiatric diagnosis,
• Being pregnant,
• Presence of infection or tumoral structure within intraoral structures
• Having a history of tooth loss, use of prosthetic teeth,
• Having a history of surgical procedures in the cervical region,
• Previous treatment related to TMD,
• be under the age of 18,
• Participants will be excluded from the study if they are in the post-menopausal stage.

Sponsors & Collaborators

• Alper Percin: lead

Study Sites (1)

Bahçeşehir University

Istanbul, Beşiktaş, 34000, Turkey (Türkiye)

Location

Related Publications (21)

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  PMID: 30429897 BACKGROUND

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  BACKGROUND

• Gillespie BR. Assessment and treatment of TMJ muscles, fascia, ligaments, and associated structures. Cranio. 1990 Jan;8(1):51-4. doi: 10.1080/08869634.1990.11678300.

  PMID: 2098188 RESULT

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  PMID: 9520246 RESULT

• Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. No abstract available.

  PMID: 1298767 RESULT

• Travell JG, Simons DG. Myofascial pain and dysfunction: The trigger point manual. Baltimore: Williams and Wilkins; 5-90,1983.

  RESULT

• Ohrbach R, Michelotti A. The Role of Stress in the Etiology of Oral Parafunction and Myofascial Pain. Oral Maxillofac Surg Clin North Am. 2018 Aug;30(3):369-379. doi: 10.1016/j.coms.2018.04.011. Epub 2018 Jun 1.

  PMID: 29866454 RESULT

• Eisenlohr-Moul TA, Crofford LJ, Howard TW, Yepes JF, Carlson CR, de Leeuw R. Parasympathetic reactivity in fibromyalgia and temporomandibular disorder: associations with sleep problems, symptom severity, and functional impairment. J Pain. 2015 Mar;16(3):247-57. doi: 10.1016/j.jpain.2014.12.005. Epub 2014 Dec 24.

  PMID: 25542636 RESULT

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  PMID: 12435463 RESULT

• Tashiro A, Bereiter DA. The effects of estrogen on temporomandibular joint pain as influenced by trigeminal caudalis neurons. J Oral Sci. 2020 Mar 28;62(2):150-155. doi: 10.2334/josnusd.19-0405. Epub 2020 Mar 4.

  PMID: 32132330 RESULT

• Eze-Nliam CM, Quartana PJ, Quain AM, Smith MT. Nocturnal heart rate variability is lower in temporomandibular disorder patients than in healthy, pain-free individuals. J Orofac Pain. 2011 Summer;25(3):232-9.

  PMID: 21837290 RESULT

• Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Sarolic A, Lechner S, Klonowski W, Varoneckas G, Szeles JC. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9;13:854. doi: 10.3389/fnins.2019.00854. eCollection 2019.

  PMID: 31447643 RESULT

• Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.

  PMID: 25614179 RESULT

• Jeong KH, Kim ME, Kim HK. Temporomandibular disorders and autonomic dysfunction: Exploring the possible link between the two using a questionnaire survey. Cranio. 2023 Sep;41(5):467-477. doi: 10.1080/08869634.2021.1872313. Epub 2021 Jan 11.

  PMID: 33427101 RESULT

• Monaco A, Cattaneo R, Mesin L, Ciarrocchi I, Sgolastra F, Pietropaoli D. Dysregulation of the autonomous nervous system in patients with temporomandibular disorder: a pupillometric study. PLoS One. 2012;7(9):e45424. doi: 10.1371/journal.pone.0045424. Epub 2012 Sep 18.

  PMID: 23028999 RESULT

• Robinson LJ, Durham J, MacLachlan LL, Newton JL, Autonomic function in chronic fatigue syndrome with and without painful temporomandibular disorder. Pages 205-219 | Received 22 May 2015, Accepted 28 Aug 2015, Published online: 05 Oct 2015. https://doi.org/10.1080/21641846.2015.1091152

  RESULT

• Gomes NC, Berni-Schwarzenbeck KC, Packer AC, Rdrigues-Bigaton D. Effect of cathodal high-voltage electrical stimulation on pain in women with TMD. Rev Bras Fisioter. 2012 Jan-Feb;16(1):10-5. English, Portuguese.

  PMID: 22441222 RESULT

• Blanco-Aguilera A, Blanco-Hungria A, Biedma-Velazquez L, Serrano-Del-Rosal R, Gonzalez-Lopez L, Blanco-Aguilera E, Segura-Saint-Gerons R. Application of an oral health-related quality of life questionnaire in primary care patients with orofacial pain and temporomandibular disorders. Med Oral Patol Oral Cir Bucal. 2014 Mar 1;19(2):e127-35. doi: 10.4317/medoral.19061.

  PMID: 24121906 RESULT

• Gil-Martinez A, Paris-Alemany A, Lopez-de-Uralde-Villanueva I, La Touche R. Management of pain in patients with temporomandibular disorder (TMD): challenges and solutions. J Pain Res. 2018 Mar 16;11:571-587. doi: 10.2147/JPR.S127950. eCollection 2018.

  PMID: 29588615 RESULT

• Vijila JY. (2016). Effectiveness of Muscle Energy Technique and Rocabado Exercise Versus Therapeutic Jaw Exercises for Temporomandibular Joint Dysfunction (Doctoral dissertation, Nandha College of Physiotherapy, Erode).

  RESULT

• Percin A, Basat H, Ozden AV, Yenisehir S. The effect of auricular vagus nerve stimulation in women with temporomandibular joint disorders: a randomized controlled study. Rev Assoc Med Bras (1992). 2025 Jun 2;71(4):e20241739. doi: 10.1590/1806-9282.20241739. eCollection 2025.

  PMID: 40465996 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Study Officials

• Hande Başat, M.D.

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be informed about which treatment was given in the other group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle İnvestigator

Model Details: All groups will be involved physical therapy and both groups will have traditional rehabilitation program for TMD. Only the group 1 will also have auricular non-invasive vagus nerve stimulation.

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 15, 2022
• Study Start: August 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: November 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)