Trial record 9 of 12 for:    temporomandibular joint dysfunction AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fabrizio Sgolastra, University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01832207
First received: April 9, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 Intervention
Temporomandibular Disorders
Device: Transcutaneous electrical nerve stimulation
Device: Placebo transcutaneous electrical nerve stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of L'Aquila:

Primary Outcome Measures:
  • sEMG values [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by University of L'Aquila

Additional 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
Study First Received: April 9, 2013
Last Updated: April 15, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 01, 2014