Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial

April 15, 2013 updated by: Fabrizio Sgolastra, University of L'Aquila
Background The purpose of the present controlled clinical trial was to assess the effect of a single 60 min application of transcutaneous electrical nervous stimulation (TENS) at sensory stimulation threshold (STS), compared to the application of motor stimulation threshold (MTS) as well as to untreatment, on the surface electromyographic (sEMG) and kinesiographic activity of patients with temporomandibular disorder (TMD). Methods Sixty female subjects, selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in remission were assigned to MTS, STS or untreatment. Pre- and post-treatment differences in the sEMG activity of temporalis anterior (TA), masseter (MM), digastric (DA) and sternocleidomastoid muscles (SCM), as well in the interocclusal distance (ID), within group were tested using the Wilcoxon test, while differences among groups were assessed by Kruskal-Wallis test; the level of significance was set at p ≤ 0.01.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age less than 30 years;
  • female gender
  • right-handed (7-10 points in Edinburgh inventory);
  • presence of complete permanent dentition, with the exception of the third molars;
  • normal occlusion;
  • diagnosis of unilateral arthrogenous TMD on the Research Diagnostic Criteria for TMD (RDC/TMD), Axis I, groups II and III

Exclusion Criteria:

  • having pacemaker or other electrical devices
  • previous experience of TENS or biofeedback
  • systemic diseases
  • history of local or general trauma
  • neurological or psychiatric disorders
  • muscular diseases
  • cervical pain
  • bruxism diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding
  • pregnancy
  • assumption of anti-inflammatory, analgesic, antidepressant or myorelaxant drugs
  • fixed or removable prostheses
  • fixed restorations that affected the occlusal surfaces
  • previous or concurrent orthodontic or orthognathic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Placebo
Device: Placebo transcutaneous electrical nerve stimulation
Active Comparator: MTS
Motor threshold of stimulation
Device: Transcutaneous electrical nerve stimulation
Active Comparator: STS
Sensorial threshold of stimulation
Device: Transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sEMG values
Time Frame: 60 min
60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimate)

April 16, 2013

Study Record Updates

Last Update Posted (Estimate)

April 16, 2013

Last Update Submitted That Met QC Criteria

April 15, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMD-224301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Temporomandibular Disorders

Clinical Trials on Transcutaneous electrical nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe