NCT05272488 A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation in Patients With Myogenic Temporomandibular Disorders
| NCT ID | NCT05272488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alcala |
| Condition | Temporomandibular Joint Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-08-01 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Alejandro Ferragut-Garcías, PhD
STUDY CHAIR
Universidad Islas Baleares
Frequently Asked Questions
Who can join the NCT05272488 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Temporomandibular Joint Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05272488 currently recruiting?
Yes, NCT05272488 is actively recruiting participants. Contact the research team at info@institutofisioterapiaydolor.es for enrollment information.
Where is the NCT05272488 trial being conducted?
This trial is being conducted at Alcalá de Henares, Spain, Alcalá de Henares, Spain, Alcalá de Henares, Spain.
Who is sponsoring the NCT05272488 clinical trial?
NCT05272488 is sponsored by University of Alcala. The principal investigator is Alejandro Ferragut-Garcías, PhD at Universidad Islas Baleares. The trial plans to enroll 60 participants.