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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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27 May 2013 |
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Main ID: |
RBR-6z42q3 |
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Date of registration:
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11/04/2012 |
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Primary sponsor: |
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Public title:
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Evaluation of a type of therapy for the treatment of vaginal pain during intercourse.
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Scientific title:
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Electrical stimulation of the pelvic floor in the treatment of women with chronic vulvar pain |
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Date of first enrolment:
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02/01/2011 |
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Target sample size:
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64 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-6z42q3/ |
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Study type:
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Intervention |
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Study design:
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Therapeutic, parallel, with 2 arms, single-blinded, randomized clinical trial.
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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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Paulo
Giraldo |
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Address:
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R. Alexander Fleming 101, Cidade Universitária-Barão Geraldo
13083-881
Campinas
Brazil |
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Telephone:
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(19)03521.9306 |
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Email:
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giraldo@unicamp.br |
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Affiliation:
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Faculdade de Ciências Médicas - Universidade Estadual de Campinas |
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Name:
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Paulo
Giraldo |
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Address:
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R. Alexander Fleming 101, Cidade Universitária-Barão Geraldo
13083-881
Campinas
Brazil |
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Telephone:
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(19)03521.9306 |
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Email:
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giraldo@unicamp.br |
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Affiliation:
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Faculdade de Ciências Médicas - Universidade Estadual de Campinas |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women with vulvodynia symptons, for, at least 6 months
Women with positive test for vulvodynia
Women willing to participate and to accept and sign voluntarily, the consent term
Exclusion criteria: Women who use intrauterine device
Pregnancy
Women who use pacemakers
Women who have some sort of metal implant in the region of the lumbar spine or hip
Women who have neoplasic diseases
Women with acute infectious process in the vulvar region
Chronic Immunosuppression
Deformity of the spine or pelvis
Genital ulcer
Women on medications that may cause mucositis (eg prolonged use of antibiotics, immunomodulators, chemotherapeutics)
Women with systemic or acute allergic framework (localized)
Women who are known to have chronic degenerative disease (eg Acquired immunodeficiency syndrome, renal transplant, lupus, tuberculosis)
Age minimum:
18Y
Age maximum:
45Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Vulvodynia
C13.351.500.944.951
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Intervention(s)
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Group 1- 32 subjects were submitted to electrical stimulation with interferential current (4000Hz, MFA 110Hz, 60Hz DAMF) for 20 minutes at the rate 1-2 times per week, total of 8 sessions.
Group 2 - 32 volunteers underwent the same treatment protocol in group 1, but the electric current was not issued, and the placebo group.
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Primary Outcome(s)
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Improved sexual function score evaluated by the Female Sexual Function Index;
Improvement in pain on examination evaluated by visual analog scale
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Reduction of pain during intercourse after tratamentro with interferential current evaluated by Visual Analog Scale, reported by the patient.
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Secondary Outcome(s)
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Improved intravaginal basal tone, the maximum force of contraction of the vaginal muscles, and the resistance of the vaginal muscles, assessed before and after treatment using electromyographic analysis (uV) and pressure (mmHg) with the device Miotool.
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Secondary ID(s)
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0024.0.146.000-09
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Source(s) of Monetary Support
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Fundação de Apoio à Pesquisa do Estado de São Paulo - São Paulo, SP, Brazil
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