Transcutaneous auricular Vagus Nerve Stimulation for the treatment of myoarthropatic symptoms in patients with craniomandibular dysfunction – a randomized and controlled pilot trial

Not Applicable

• Conditions: Temporomandibular joint dysfunction; K07.6; Temporomandibular joint disorders

• Registration Number: DRKS00029724
• Lead Sponsor: Heinrich-Heine-Universität Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-03
• Study Completion: 2024-06-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of the severity of pain and quality of life should be evaluated with different questionnaires.

Secondary Outcome Measures

Name	Time	Method
As secondary outcomes the impact of the mandibular mobility and muscles activity should be recorded.