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

Heinrich-Heine-Universität Düsseldorf0 个研究点目标入组 20 人开始时间: 2022年8月3日最近更新: 2024年8月19日

适应症

试验速览

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•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

•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

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