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Muscle Pain on the face,stress hormone and heart beat in patients with joint dysfunction of the mouth treated with laser

Evaluation myofascial chronic pain in pacients with Temporomandibular disorders and its relationship with serum cortisol and heart rate variability after intervention physiotherapic by low level laser therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-2qdv84
Enrollment
Unknown
Registered
2011-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular disorders (TMD) myofascial chronic pain in TMD

Interventions

Each volunteer followed the sequence: Clinical evaluation of volunteer with a clinical diagnosis of Temporomandibular Disorders
Eletrocardiogram during 15 minutes of rest and 15 minutes inclined to heart rate variability analysis
The register of pain intensity in the visual analog scale before each low level laser application and after 5 minutes of the end
Collection of peripheral blood for cortisol analysis
10 interventions with low level laser on alternate days, with a frequency of 3 times per week
Reevaluation of patients with a clinical diagnosis of Temporomandibular Disorders
Eletrocardiogram for analysis of heart rate variability after 10 sessions of low level laser therapy
Collection of peripheral blood after 10 sessions of low level laser therapy.
device
SP4.016.147.648.099

Sponsors

Faculdade São Lucas
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 65 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: REBEC (via WHO ICTRP)