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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01832207
Other study ID # TMD-224301
Secondary ID
Status Completed
Phase N/A
First received April 9, 2013
Last updated April 15, 2013
Start date January 2010
Est. completion date February 2012

Study information

Verified date April 2013
Source University of L'Aquila
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcutaneous electrical nerve stimulation

Placebo transcutaneous electrical nerve stimulation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of L'Aquila

Outcome

Type Measure Description Time frame Safety issue
Primary sEMG values 60 min
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