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TEMPOROMANDIBULAR JOINT DISEASES clinical trials

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NCT ID: NCT02789085 Enrolling by invitation - Clinical trials for TEMPOROMANDIBULAR JOINT DISEASES

ANS Effects of ULF-TENS Stimulation in Patients With and Without TMD

Start date: November 2013
Phase: Phase 0
Study type: Interventional

Using computerized pupillometry, previous research established that the autonomic nervous system (ANS) is dysregulated in patients who suffer from temporomandibular disorders (TMDs), suggesting a potential role for ANS dysfunction in pain modulation and the etiology of TMD. However, pain modulation hypotheses in TMD are still lacking. The periaqueductal gray (PAG) is involved in the descending modulation of defensive behavior and pain through μ, κ, and δ opioid receptors. Transcutaneous electric nerve stimulation (TENS) has been extensively used for pain relief, as low-frequency stimulation is able to activate µ receptors. The aim of the present study is to use ANS polygraph and salivary/serum biomarkers to evaluate the effect of low-frequency TENS stimulation of ANS in TMD patients. According to the Research Diagnostic Criteria for TMD, people with myogenous TMD and matched-controls will be enrolled. All subjects will be randomly assigned to control group (no tens stimulation) and case group (test stimulation); subsequently, ANS parameters by both biomarkers and ANS polygraph, before, soon after (end of stimulation), and late after (recovery period) sensorial TENS will be collected. The overall statistics will be performed from all conditions recorded comparing controls vs cases. The expected results consist in discovering ANS deregulation in TMD with and without TENS stimulation.