Combining manual therapy and vagus nerve stimulation for jaw pain relief
A Combined Treatment of Manual Therapy and Nervous Vagus Stimulation Versus a Treatment of Manual Therapy Isolated in Patients With Myogenic Temporomandibular Disorders
This study is testing if combining manual therapy with vagus nerve stimulation can help people with jaw pain feel better and improve their jaw movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alcala Academic / other |
| Locations | 3 sites (Alcalá de Henares, Madrid and 2 other locations) |
| Trial ID | NCT05272488 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining manual therapy with vagus nerve stimulation in treating myogenic temporomandibular disorders (TMD). The approach aims to address both muscle and nerve influences on pain and jaw functionality. Patients will be randomly assigned to either the experimental group receiving both treatments or a control group receiving manual therapy with a placebo for vagus nerve stimulation. The study will evaluate pain reduction, joint range of motion, and overall quality of life improvements. A team of physiotherapists will manage treatment, screening, and statistical analysis to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing myogenic pain related to TMD with reduced jaw function and no recent physiotherapy treatment.
Not a fit: Patients with joint or mixed origin TMD, severe systemic diseases, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve jaw function for patients suffering from TMD.
How similar studies have performed: While the combination of manual therapy and vagus nerve stimulation is a novel approach, similar studies have shown promise in treating pain through manual therapy alone.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alcalá de Henares, Madrid and 2 other locations
- Clinical University Physiotherapy and pain — Alcalá de Henares, Madrid, Spain (Recruiting)
- Martinez-Merinero, Patricia — Alcalá de Henares, Madrid, Spain (Recruiting)
- Physioterapy and Pain center research — Alcalá de Henares, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Patricia Martinez-Merinero, PhD
- Email: info@institutofisioterapiaydolor.es
- Phone: +34 683 378 391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.