Temporomandibular disorders (TMD) myofascial chronic pain in TMD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male interstate professional bus drivers who agree to sign the Informed Consent Term.
Exclusion criteria
Exclusion criteria: Subjects with ischemic and dilated heart disease; Subjects with episodes of acute decompensation in the two months prior to the study protocol; Subjects with primary heart valve disease; or acute or chronic cardiopulmonary or neuromuscular diseases; Subjects who have been submitted to recent surgical procedures in the region of the chest wall; or those with a history of stroke, drug users and those who abuse alcohol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 3: Apnea/hypopnea index (AHI). (Apnea was defined as complete cessation of airflow for > 10 seconds, associated with oxygen desaturation of 3%. Hypopnea was defined as a significant reduction (>50%) in respiratory signals for > 10 seconds associated with oxygen desaturation of 4%. The AHI was calculated as the total number of respiratory events (apneas plus hypopneas) per hour of sleep through standart overnight polysomnography. Timepoint: This will be measured after the clinical and demographic collecting data, by the standard overnight polysomnography. ;Primary outcome 1: [Expiratory flow limitation as flow drop (V`), expressed as the percentage of expiratory peak flow immediately after negative expiratory pressure application. Timepoint: This will be measured after the clinical and demographic collecting data and after the obstruction diagnosis by spirometry is discarded. ;Primary outcome 2: [Volume expired in 0.2s (V0.2s) immediately after negative expiratory pressure administration] Timepoint: This will be measured after the clinical and demographic collecting data and after the obstruction diagnosis by spirometry is discarded. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1: [High/low risk at Berlin Questionnaire which is a 10-item questionnaire with recognized efficacy in distinguishing subjects at greater risk for OSA] Timepoint: This will be measured after the clinical and demographic collecting data. ;Secondary outcome 2: [Score at the Epworth Scale, which is used for the assessment of excessive daytime sleepiness] Timepoint: This will be measured after the clinical and demographic collecting data. ;Secondary outcome 3: [Waist circumference as assessed at physical exam]. Timepoint: At the physical exam. ;Secondary outcome 4: [Neck circumference as assessed at physical exam]. Timepoint: At the physical exam. ;Secondary outcome 5: [Mallampati index (I – IV score) as assessed with the patient with the mouth wide opened and voluntary protrusion of the tongue without phonation]. Timepoint: At the physical exam. ;Secondary outcome 6: [Work experience which is the time working as a professional driver]. Timepoint: At the medical exam. ;Secondary outcome 7: [all items composing the criteria for clinical diagnostic of Metabolic Syndrome (elevated waist circumference, elevated tryglicerides, reduced high-density lipoprotein cholesterol – HDL-C, elevated blood pressure and elevated fasting glucose) as assessed by data linkage to medical records]. Timepoint: at first time, before initiating the protocol study. ;Secondary outcome 8: [body mass index – BMI, as assessed by data linkage to medical records]. Timepoint: at first time, before initiating the protocol study. ;Secondary outcome 9: [Sleep efficiency, as assessed by the standart overnight polysomnography]. Timepoint: This will be measured after the clinical and demographic collecting data, by the standard overnight polysomnography. ;Secondary outcome 10: [Time with peripherical oxyhemoglobin saturation - SpO2 < 90%, as assessed by the standart overnight polysomnography]. Timepoint: This will be measured after the clinical and demographic collecting | — |
Countries
Brazil