A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders

NCT05272488 | Recruiting

• 1 other identifier: CEIM/2021/6/144
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

Temporomandibular disorders (TMD) are one of the most important Public Health issues in the world and its incidence has increased over the years. The Physiotherapy and manual therapy techniques has shown its efficacy to reduce pain and to improve jaw functionality in patients with TMD. Until now, treatment targets has been the muscle and joint, but clinicians has not taken into account the innervation and how the nerve can have an influence in pain or jaw functionality. In this sense, it is known that there is a relationship between jaw innervation and vagus nerve, a parasympathetic nerve which is easily stimulable, due to its connection with the respiratory system, taking deep breaths using the diaphragm. Therefore, our hypothesis is that a treatment in which clinicians combine manual therapy and nerve vagus stimulation could have better effects (reducing pain, increasing range of motion in temporomandibular joints and improving quality of life in patients with TMD) than a isolated manual therapy treatment. With this purpose will be selected 20 subjects to participate in our study divided in two groups. Both groups will received 4 sessions of physiotherapy (one each 7 days during one month) and also will be thought to do own treatment those days the subjects does not come to the clinic until the study will have finished (the interventional period last two months). Both groups will received the same manual therapy techniques but only the experimental group will be treated with nerve vagus stimulation technique. One member of the group who will not participated in the interventions will be in charge of do evaluations (1 each month/ a total of 3 evaluations) following different questionaries to assess the primary variables of the study: chronic pain level, jaw functionality, physical symptoms level, range of motion and distress level.

Conditions

Temporomandibular Joint Disorders; Pain

Keywords

Temporomandibular Joint; Manual therapy

Outcome Measures

Primary Outcomes (2)

• Patient´s state of health

  An interpretation of the improvement of patient´s state of health related with temporomandibular disorders taking into account other improvements in differents areas/variables which will be described as secondary outcomes

  Change from baseline at 2 months

• Graded Chronic Pain Scale (CPGS)

  The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions.The 3 subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting.

  Change from baseline at 2 months

Secondary Outcomes (4)

• Range of motion (Opening without pain, Maximum Opening, Lateral movements and Protrusion movement)

  Change from baseline at 2 months

• Jaw Functional Limitation Scale

  Change from baseline at 2 months

• The Patient Health Questionnaire (PHQ-15)

  Change from baseline at 2 months

• Distress Level PHQ-4

  Change from baseline at 2 months

Study Arms (2)

Manual therapy and nervous vagus stimulation

EXPERIMENTAL

Subjects will received manual therapy combined with nerve vagus stimulation.

Other: Manual therapy and vagus nerve stimulation

Manual therapy

ACTIVE COMPARATOR

Subjects will received isolated manual therapy techniques.

Other: Manual therapy

Interventions

Manual therapy and vagus nerve stimulation OTHER

A neurodinamic intervention of vagus nerve through deep breaths involving diaphragm muscle and manual therapy techniques.

Manual therapy and nervous vagus stimulation

Manual therapy OTHER

Manual therapy techniques. Joint manipulation techniques for temporomandibular joints and Soft tissue techniques for the muscles

Manual therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of myogenic pain according to the CD / TTM diagnostic criteria.
• Presence of pain during the last 30 days.
• Patients with decreased jaw function and mobility due to pain.
• Patients who have not received physiotherapy treatment in the last 3 weeks.
• Patients of legal age.

You may not qualify if:

• Patients with drug treatment: sedatives, anti-inflammatories, antidepressants, anxiolytics or muscle relaxants.
• Patients with cardiac pacemakers and implanted defibrillators. Patients diagnosed with severe cardiorespiratory and / or respiratory diseases, carcinogenic processes, infectious processes and / or systemic pathologies.
• Clinical diagnosis of temporomandibular disorder of joint or mixed origin according to the Diagnostic Criteria for Temporomandibular Disorders (CD / TMD).
• Patients with psychiatric or psychological disorders, intellectual or motor deficiencies that, due to their nature, prevent them from correctly performing the prescribed exercises, correctly following the physiotherapist's instructions or understanding the questionnaires and / or measurement scales of the variables.
• Patients with dental processes scheduled during the study period or who have undergone surgery in the last 3 months.
• Patients with suspicion or certainty that their pain has appeared as a consequence of a local or general trauma.
• Patients diagnosed with fibromyalgia, neuropathic pain or degenerative diseases

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (3)

Clinical University Physiotherapy and pain

Alcalá de Henares, Madrid, 2805, Spain

RECRUITING

Martinez-Merinero, Patricia

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Physioterapy and Pain center research

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Interventions

Musculoskeletal Manipulations; Vagus Nerve Stimulation

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy

Study Officials

• Alejandro Ferragut-Garcías, PhD

  Universidad Islas Baleares

  STUDY CHAIR

Central Study Contacts

Patricia Martinez-Merinero, PhD

CONTACT

+34 683 378 391; info@institutofisioterapiaydolor.es

Daniel Pecos-Martin, PhD

CONTACT

+34 9188551442; daniel.pecos@uah.es

Study Design

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

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: March 9, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ES (3)