Clincosm LogoSign in Get a demo

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

Sponsor
University of L'Aquila (Other)
Overall Status
Completed
CT.gov ID
NCT01832207
Collaborator
(none)
60
Enrollment
3
Arms
25
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcutaneous electrical nerve stimulation
  • Device: Placebo transcutaneous electrical nerve stimulation
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2010
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. sEMG values [60 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of L'Aquila

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fabrizio Sgolastra, Dr, University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01832207
Other Study ID Numbers:
  • TMD-224301
First Posted:
Apr 16, 2013
Last Update Posted:
Apr 16, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Apr 16, 2013