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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-2qdv84
Date of registration: 09/07/2011
Primary sponsor: Faculdade São Lucas - Brazil
Public title: Muscle Pain on the face,stress hormone and heart beat in patients with joint dysfunction of the mouth treated with laser
Scientific title: 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
Date of first enrolment:
Target sample size: 15
Recruitment status: terminated
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-2qdv84/
Study type: 
Study design:  Clinical Trial. of single-arm, non-randomized, open, phase 4  
Countries of recruitment
Brazil
Contacts
Name: Marcelo  Rubira
Address:  Rua Alexandre Guimarães, 3062, apto 502, Bairro Areal, 76804-373 Porto Velho Brazil
Telephone: 69 9228-9889
Email: rubiramc@terra.com.br
Affiliation:  Faculdade São Lucas
Name: Marcelo  Rubira
Address:  Rua Alexandre Guimarães, 3062, apto 502, Bairro Areal, 76804-373 Porto Velho Brazil
Telephone: 69 9228-9889
Email: rubiramc@terra.com.br
Affiliation:  Faculdade São Lucas
Key inclusion & exclusion criteria
Inclusion criteria: Female gender, non-smokers, normotensive, age group between 18 and 40 years, with diagnosis of temporomandibular disorder, presenting orofacial chronic pain (Gratt, Anbar 2005), which suggest that chronic pain is the pain that persists for more than four months, body mass index (BMI) normal and overweight (normality value of 18.5 to 27.5 Kg/m2) sent to physiotherapeutic treatment.

Exclusion criteria: Volunteers with medical and/or dental emergencies, metabolic diseases (such as diabetes or hyperthyroidism), neurological disorders (e.g. , disquinesia and/or neuralgia of the trigeminus nerve etc. ), vascular disease (for example, hypertension), cancer, past history of psychiatric disorders, drug abuse, pregnant or breastfeeding women, history of recent accidents with powered vehicle, volunteers currently treated with medications for neurological disorders or psychological and making use of analgesics or nsaids, were also excluded.


Age minimum: 18Y
Age maximum: 40Y
Gender: F
Health Condition(s) or Problem(s) studied
M00-M99
Temporomandibular disorders (TMD) myofascial chronic pain in TMD
C05.550.091
Intervention(s)
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.
Primary Outcome(s)
The results :

The analgesic therapeutic with Laser increased the blood cortisol levels measured in the blood and within normal parameters;
Reduced muscle tension of the face and head muscles verified by increase of the range of motion of the mandibular movements measured in millimeters with a pachymeter and lower levels of pain on palpation by physical examination;
LLLT applied for pain of the volunteers Reduced the increase in sympathetic nerve activity on the heart, spectrum of very low frequency (VLF) and spectra of low frequency (LF)measured by analysis of the eletrocardiogram.
Secondary Outcome(s)
Secondary ID(s)
127/2007
Source(s) of Monetary Support
Faculdade São Lucas - Brazil
Secondary Sponsor(s)
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