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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

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation
Placebo transcutaneous electrical nerve stimulation
Sponsored by
University of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    MTS

    STS

    Placebo

    Arm Description

    Motor threshold of stimulation

    Sensorial threshold of stimulation

    Outcomes

    Primary Outcome Measures

    sEMG values

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2013
    Last Updated
    April 15, 2013
    Sponsor
    University of L'Aquila
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01832207
    Brief Title
    Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of L'Aquila

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MTS
    Arm Type
    Active Comparator
    Arm Description
    Motor threshold of stimulation
    Arm Title
    STS
    Arm Type
    Active Comparator
    Arm Description
    Sensorial threshold of stimulation
    Arm Title
    Placebo
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Transcutaneous electrical nerve stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Placebo transcutaneous electrical nerve stimulation
    Primary Outcome Measure Information:
    Title
    sEMG values
    Time Frame
    60 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23672400
    Citation
    Monaco A, Sgolastra F, Pietropaoli D, Giannoni M, Cattaneo R. Comparison between sensory and motor transcutaneous electrical nervous stimulation on electromyographic and kinesiographic activity of patients with temporomandibular disorder: a controlled clinical trial. BMC Musculoskelet Disord. 2013 May 15;14:168. doi: 10.1186/1471-2474-14-168.
    Results Reference
    derived

    Learn more about this trial

    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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