Comparison Between Sensory and Motor Transcutaneous Electrical Nervous Stimulation on Electromyographic and Kinesiographic Activity of Patients With Temporomandibular Disorder: a Controlled Clinical Trial
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedApril 16, 2013
April 1, 2013
2 years
April 9, 2013
April 15, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
sEMG values
60 min
Study Arms (3)
MTS
ACTIVE COMPARATORMotor threshold of stimulation
STS
ACTIVE COMPARATORSensorial threshold of stimulation
Placebo
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23672400DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 16, 2013
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
February 1, 2012
Last Updated
April 16, 2013
Record last verified: 2013-04