Temporomandibular joint dysfunction K07.6
Conditions
Interventions
Group 1: Intervention group: The taVNS is performed on the tragus of the right ear according to the device approval. A stimulation frequency of 25hz and a puls width of 250µs in an on/off-scheme (28s
Sponsors
Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria will consider the following: - Chronic Temporomandibular disorders (TMD) - Age >18 years - Provided written informed consent to participate in the trial - Positive response to the question, "Do you have pain in the right side of your face, the left side, or both?" - Grade III or IV of the Graduation of Chronic Pain Scale (GCPS) - No depression or a depression that has been stably treated for 4 weeks
Exclusion criteria
Exclusion criteria: The exclusion criteria will consider the following: - Orofacial pain or diagnosis(es) that do not qualify as myalgia, myofascial pain, or arthralgia based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) - Severe neurological disorders such as schizophrenia - Interventions with vagus nerve stimulation or history of vagotomy - History of relevant cardiac diseases: bradycardic arrhythmia (e.g. sick sinus syndrome), heart failure, condition after myocardial infarction - Active implant, such as pacemaker, defibrillator, neurostimulator, cochlear implant or drug delivery device, and ventricular shunt - Inability to understand the study protocol - Progressive neurological disease (e.g., Parkinson's disease, MS, epilepsy) - Pregnancy - Prostate cancer - Presence of a skin condition such as infection, psoriasis, or eczema in the treatment area - Presence of any anatomical abnormality that prevents successful insertion of the ear electrode - Presence of any serious medical condition that prevents successful study participation - Acute tinnitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of the severity of pain and quality of life should be evaluated with different questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes the impact of the mandibular mobility and muscles activity should be recorded. | — |
Countries
Germany
Contacts
Public ContactLea Sophia Prott
Universitätsklinikum DüsseldorfPoliklinik für Zahnärztliche Prothetik
Outcome results
None listed