Clinical trial NCT02021357: Proprioceptive Treatment for Temporomandibular Dysfunction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Pain
Keywords: Facial Pain
Physical Therapy Modalities
Temporomandibular Joint Disorders
Exercise Therapy
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: 1 Year
Secondary outcomes:
measure: Electromyographic Activity
timeFrame: 1 Year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
Study officials:
affiliation: University of Nove de Julho
name: Eric Arruda
role: PRINCIPAL_INVESTIGATOR
References: