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Main
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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. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-7yxnmv |
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Date of registration:
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13/02/2012 |
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Primary sponsor: |
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Public title:
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Effects of a technique applied by the hands of the therapist in the thoracic spine in patients with temporomandibular joint and cervical disorders
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Scientific title:
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Effects of high thoracic spine manipulation on temporomandibular and cervical disorders |
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Date of first enrolment:
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26/10/2011 |
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Target sample size:
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20 |
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Recruitment status: |
not yet recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-7yxnmv/ |
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Study type:
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Study design:
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Clinical trial, two arm, randomized, triple-blind
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Delaine
Bigaton |
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Address:
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Dom João Bosco, 139
13405-137
Piracicaba
Brazil |
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Telephone:
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(19) 31241558 |
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Email:
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drodrigues@unimep.br |
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Affiliation:
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Universidade Metodista de Piracicaba |
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Name:
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Delaine
Bigaton |
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Address:
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Dom João Bosco, 139
13405-137
Piracicaba
Brazil |
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Telephone:
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(19) 31241558 |
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Email:
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drodrigues@unimep.br |
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Affiliation:
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Universidade Metodista de Piracicaba |
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Key inclusion & exclusion criteria
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Inclusion criteria: All volunteers must have:
Diagnosis of temporomandibular disorders (TMD) according to the RDC / TMD (Ia, Ib, IIa, IIb, IIc and IIIa);
Pain and / or fatigue in the masticatory muscles during functional activities for a minimum period of 3 months;
Neck pain for at least 3 months;
Diagnosed with cervical dysfunction according to the neck Disability Index (NDI);
Body Mass Index (BMI) less than 25;
Scores of pain in the masticatory muscles and cervical greater than 3 cm according to the VAS.
Exclusion criteria: Missing teeth;
Open bite;
Cross bite;
Complete dentures;
Partial systemic neuromuscular diseases;
History of trauma to the face and / or TMJ;
Joint dislocation;
In orthodontic treatment and / or medication actually affecting the musculoskeletal system (pain relievers anti-inflammatories and muscle relaxants);
Red flag as a sign of malignant, infectious or inflammatory disease that contraindicate the use of manual therapy;
Occurrence of cervical whiplash;
Previous surgery of the cervical spine;
Diagnosis of fibromyalgia;
Previous experience with management over the past two months.
Age minimum:
18Y
Age maximum:
40Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Temporomandibular disorder, cervical disorder
C05.550.091
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Intervention(s)
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Experimental group (n = 10): Women who received the manipulation technique of high speed and low amplitude in the upper thoracic region of the spine in a single session.
Placebo group (n = 10): Women who received the simulation technique, no therapeutic effect in a single session, staying in the same position in the experimental group, with the difference did not receive the thrust of high speed and low amplitude.
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Primary Outcome(s)
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Reduction of electromyographic activity of masticatory and cervical muscles at rest and an increase in this activity after isometric manipulation technique, evaluated using surface electromyography, by RMS parameter.
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Secondary Outcome(s)
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Analgesic effect in masticatory and cervical muscles after manipulation technique, assessed by visual analogue scale and algometry.
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Secondary ID(s)
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protocolo nº 62/11
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brazil
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