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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-4bk94x |
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Date of registration:
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06/12/2011 |
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Primary sponsor: |
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Public title:
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Effect of electrical stimulation on pain and masticatory muscle activity in women with temporomandibular joint dysfunction.
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Scientific title:
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Effect of high voltage electrical stimulation - negative pole - on pain and electromyographic activity of masticatory muscles in women with temporomandibular disorders. |
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Date of first enrolment:
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01/01/2010 |
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Target sample size:
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30 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-4bk94x/ |
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Study type:
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Study design:
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Clinical trial, two-arm, randomized, double-blind, phase 4.
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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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Rua 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: The study included women with TMD, diagnosed according to RDC / TMD axis I, with pain and / or fatigue in the muscles of mastication during functional activities for a minimum period of six months. The volunteers had body mass index (BMI) of up to 25 kg/m2.
Exclusion criteria: The study excluded women with missing teeth, with dental prosthesis, with systemic diseases such as osteoarthritis, osteoarthritis and diabetes, history of trauma to the face and the temporomandibular joint, joint dislocation, facial paralysis and orthodontic treatment and medication.
Age minimum:
17Y
Age maximum:
44Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Temporomandibular disorders
C05.550.091
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Intervention(s)
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Experimental Group (n=15): Women who received electrical stimulation with high voltage equipment connected.
Parameters of stimulation:
frequency of 10 Hz;
pulse width with two twin pulses of 20 microseconds each with an interval of 100 microseconds between them;
negative polarity;
voltage above 100 volts;
stimulation at motor threshold;
30 minutes of application;
10 sessions
active electrode of silicon-carbon positioned bilaterally on the masseter and the temporalis muscle and
dispersive electrode positioned in the lower cervical and upper thoracic.
Placebo Group (n=15):
The women received sham treatment with disconnected HVES equipment.
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Primary Outcome(s)
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The primary outcome in the study was analgesia, which was assessed by visual analogue scale.
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Secondary Outcome(s)
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The secondary outcome in the study was to improve motor control of the masticatory muscles, which was evaluated by surface electromyography by RMS parameter.
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Secondary ID(s)
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protocolo 21/08
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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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