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

NCT02789085 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-06-03

No results posted yet for this study

Summary

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.

Conditions

  • TEMPOROMANDIBULAR JOINT DISEASES

Interventions

DEVICE

ULF TENS stimulation

Sponsors & Collaborators

  • University of L'Aquila

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789085 on ClinicalTrials.gov