NCT Number: NCT01832207
Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial
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.
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Notify MeKey information
Conditions
Age range
18 year–30 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo transcutaneous electrical nerve stimulation
DevicePrimary outcomes
-
sEMG values
Time frame: 60 min
Sponsors and collaborators
Lead sponsor
University of L'Aquila
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Apr 16, 2013
- Registry last updated
- Apr 16, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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