Proprioceptive Treatment for Temporomandibular Dysfunction

Facial Pain Clinical Trial

Official title:

The Influence of Proprioceptive Treatment for the Intensity of Pain, Muscle Activity, Level of Severity and Mandible Mobility in Individuals With Temporomandibular Dysfunction: Clinical Trial, Randomized, Controlled, Double-Blind

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021357
• Other study ID #: ERC-2205-AR
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2022
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The project aims to assess the effects of proprioceptive treatment through the use of hyperbolid mastication apparatus on pain intensity, muscle activity and joint mobility in subjects with TMD. A randomized, blind, clinical trial will be conducted. Volunteers aged between 18 and 40 years will be recruited, with a diagnosis of muscle- and joint-related TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in three different groups: Group 1 (G1) - treated with HB device combined with tongue exercises on the palate; Group 2 (G2) - treated HB alone and Group 3 (G3) - control. Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in two stages: before applying the treatment and after the last session.

Description:

The temporomandibular disorder (TMD) are characterized by a set of clinical abnormalities involving the masticatory muscles, the temporomandibular joint (TMJ) and other associated structures. Several studies have supported the use of physical therapy in the treatment of this condition, especially electrotherapy, laser therapy and manual resources. However, despite advances in the search for scientific evidence, it is necessary to prove to other commonly used clinical measures in subjects with TMD, such as the use of hyperbolid, which is a feature that stimulates the proprioceptive function. Thus, this project aims to assess the effects of proprioceptive treatment through the use of hyperbolid on pain intensity, muscle activity and joint mobility in subjects with TMD. A randomized, blind, clinical trial will be conducted. Volunteers aged between 18 and 40 years will be recruited, with a diagnosis of muscle- and joint-related TMD according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC / TMD), being randomly divided in three different groups, the first group constituted by treatment with hyperbolid associated with tongue exercises on the palate, the second group consists of treatment with hyperbolid alone and the third group will not receive any type of intervention (proprioceptive treatment will be offered after the study period). Treatment protocols will be applied for 12 sessions, the volunteers will be evaluated in two stages: before applying the treatment and after the last session. The variables that will be investigated are: pain assessed using visual analog scale and algometry; muscle activity, investigated by electromyography of masticatory muscles; and joint mobility, measured by the use of a caliper. Regarding the analysis of the data will be held intragroup comparisons, considering the pre-treatment and after twelve sessions, and comparisons between groups. To this end it will be applied the Shapiro-Wilk test for checking the normality of data, and the statistical test applied consistent, then parametric or nonparametric. Is assumed a significance level of 5%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Temporomandibular Joint Disorders according to the RDC / TMD questionnaire,

• 18 to 40 years

Exclusion Criteria:

• History of neurological disorders

• Submit dental flaws,

• Sull or partial denture,

• Systemic diseases, neuromuscular,

• History of trauma to the face and or ATM

• History of TMJ luxation.

• Being in orthodontic treatment or medication that affects the musculoskeletal system.

Related Conditions & MeSH terms

• Facial Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Behavioral:
• hyperbolid combined with tongue exercises on the palate

Other:
• hyperbolid

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity was assessed using the visual analog scale, RDC/TMD Pain Index.	1 Year
Secondary	Electromyographic Activity	Muscle activity was assessed using the EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment	1 Year

External Links

•   University web site