Completed

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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What is being tested

Transcutaneous electrical nerve stimulation

+ Transcutaneous electrical nerve stimulation

+ Placebo transcutaneous electrical nerve stimulation

Device
Who is being recruted

Jaw Diseases+5

+ Joint Diseases

+ Mandibular Diseases

From 18 to 30 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2010
See protocol details

Summary

Principal SponsorUniversity of L'Aquila
Last updated: April 16, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of L'Aquila
Last updated: April 16, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Jaw DiseasesJoint DiseasesMandibular DiseasesStomatognathic DiseasesMuscular DiseasesMusculoskeletal DiseasesCraniomandibular DisordersTemporomandibular Joint Disorders

Criteria

6 inclusion criteria required to participate
age less than 30 years

diagnosis of unilateral arthrogenous TMD on the Research Diagnostic Criteria for TMD (RDC/TMD), Axis I, groups II and III

female gender

normal occlusion

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13 exclusion criteria prevent from participating
assumption of anti-inflammatory, analgesic, antidepressant or myorelaxant drugs

bruxism diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding

cervical pain

fixed or removable prostheses

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Motor threshold of stimulation

Group II

Active Comparator
Sensorial threshold of stimulation

Group III

Sham

Study Objectives

Primary Objectives

Study Centers

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CompletedNo study centers