Temporomandibular Disorders
Conditions
Interventions
This is a two-arm,parallel randomized controlled clinical trial with a comparison group and double blinding,conducted in accordance with the guidelines established by the Consolidated Standards of Rep
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; between 18 and 80 years; with somatosensory tinnitus according to the tinnitus diagnostic decision tree classification by Michiels et al. (2022); characterized by a simultaneous increase or decrease in tinnitus and neck/jaw pain; tension in the suboccipital muscles; somatic modulation and bruxism
Exclusion criteria
Exclusion criteria: Tinnitus resulting from otological pathologies; history of ear trauma or previous ear surgery; sensorineural hearing loss; sinusitis; history of psychiatric disorders; progressive middle ear pathologies; intracranial pathology; traumatic injury or previous surgery of the cervical spine orofacial region or temporomandibular joint; tumors; recent treatment of the temporomandibular joint or cervical region within the last 2 months; cognitive impairment assessed by the mini-mental state examination (MEEM) with a cutoff score of 19 for illiterate individuals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess tinnitus severity.This outcome will be verified using the Brazilian version of the Tinnitus Handicap Inventory. The total score of the instrument, ranging from 0 to 100 points, will be observed, with a reduction in the score considered indicative of improvement in tinnitus severity.;To assess tinnitus-related annoyance.This outcome will be verified using the Visual Analog Scale (VAS) for tinnitus annoyance. The self-reported value on a scale from 0 to 10 will be observed, with a decrease in the score considered indicative of reduced tinnitus-related annoyance.;To assess tinnitus intensity. This outcome will be verified using the Visual Analog Scale (VAS) for tinnitus intensity. The self-reported numerical value on a scale from 0 to 10 will be observed, with lower values indicating a reduction in the perceived loudness of tinnitus. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess tinnitus-related functionality.This outcome will be verified using the Tinnitus Functional Index (TFI). The total score of the instrument, ranging from 0 to 100 points, will be observed, with lower scores indicating better tinnitus-related functionality.;To assess participants’ sleep quality.This outcome will be verified using the Pittsburgh Sleep Quality Index (PSQI). The global score of the instrument, ranging from 0 to 21 points, will be observed, with lower scores indicating better sleep quality.;To assess postural balance.This outcome will be verified using the Biodex Balance System. Stability indices provided by the device will be observed, with a reduction in values considered indicative of improved postural control.;To assess the range of motion of the cervical and temporomandibular regions.This outcome will be verified through the use of a caliper and the Baiobit system. Range of motion values obtained before and after the intervention will be observed, with an increase in amplitude considered indicative of functional improvement.;To assess the presence of somatic modulation of tinnitus, myofascial trigger points, and pressure pain threshold. This outcome will be verified through the performance of cervical and temporomandibular somatic maneuvers, according to a standardized protocol. An increase or decrease in tinnitus intensity during the maneuvers will be observed. The presence of trigger points and pain sensitivity at specific muscle sites will also be recorded using a portable pressure algometer, with an increase in the pressure pain threshold considered indicative of reduced pain sensitivity. | — |
Countries
Brazil
Contacts
Public ContactRúbia Braz
Universidade Federal de Pernambuco
Outcome results
None listed