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

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ClinicalTrials.gov Identifier: NCT01832207
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Information provided by (Responsible Party):
Fabrizio Sgolastra, University of L'Aquila

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorders Device: Transcutaneous electrical nerve stimulation Device: Placebo transcutaneous electrical nerve stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial
Study Start Date : January 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. sEMG values [ Time Frame: 60 min ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fabrizio Sgolastra, Dr, University of L'Aquila
ClinicalTrials.gov Identifier: NCT01832207     History of Changes
Other Study ID Numbers: TMD-224301
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Disease
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes