<?xml version="1.0" encoding="UTF-8"?>

<!DOCTYPE trials SYSTEM "http://localhost:8000/xml/opentrials.dtd">
<trials version="1">
    
    <trial language="en"
           status="published"
           date_registration="2012-04-11"
           created="2011-12-26"
           updated="2012-12-20">
        <trial_identification>
            <trial_id>RBR-6z42q3</trial_id>
            <utrn_number>U1111-1126-6729</utrn_number>
            <reg_name>REBEC</reg_name>
            <public_title>Evaluation of a type of therapy for the treatment of vaginal pain during intercourse.</public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Electrical stimulation of the pelvic floor in the treatment of women with chronic vulvar pain</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
        </trial_identification>

        <sponsors_and_support>
            <primary_sponsor country_code="BR" type="higher_education_institution">
                <name>Faculdade de Ciências Médicas - Universidade Estadual de Campinas</name>
                <address>Rua: Tessália Vieira de Camargo, 126
 Cidade Universitária &quot;Zeferino Vaz&quot; - Campinas - SP - Brasil - CEP: 13083-887 </address>
                <state>SP</state>
                <city>Campinas</city>
            </primary_sponsor>

            
            <secondary_sponsor country_code="BR" type="higher_education_institution">
                <name>Faculdade de Ciências Médicas - Universidade Estadual de Campinas</name>
                <address>Rua: Tessália Vieira de Camargo, 126
 Cidade Universitária &quot;Zeferino Vaz&quot; - Campinas - SP - Brasil - CEP: 13083-887 </address>
                <state>SP</state>
                <city>Campinas</city>
            </secondary_sponsor>
            

            
            <source_support country_code="BR" type="state_research_support_foundation">
                <name>Fundação de Apoio à Pesquisa do Estado de São Paulo</name>
                <address>R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 São Paulo/SP - Brasil
 Tel:             ( 55) 11 3838-4000       Fax: ( 55) 3645-2421 </address>
                <state>SP</state>
                <city>São Paulo</city>
            </source_support>
            
        </sponsors_and_support>

        <health_conditions>
            
            <hc_code vocabulary="decs" version="" code="C23">
                <text>Pathological conditions, signs and symptoms</text>
                
                
                <text_translation lang="es">Condiciones patológicas, signos y síntomas</text_translation>
                
                <text_translation lang="pt-br">Condições patológicas, sinais e sintomas</text_translation>
                
                
            </hc_code>
            

            
            <keyword vocabulary="decs" version="" code="C13.351.500.944.951">
                <text>Vulvodynia</text>
                
                
                <text_translation lang="es">Vulvodinia</text_translation>
                
                <text_translation lang="pt-br">Vulvodínia</text_translation>
                
                
            </keyword>
            

            <freetext>Vulvodynia</freetext>
        </health_conditions>

        <interventions>
            
            <i_code value="other"></i_code>
            

            
            <keyword vocabulary="decs" version="" code="H02.010.625">
                <text>Physical Therapy Specialty</text>
                
                
                <text_translation lang="es">Fisioterapia</text_translation>
                
                <text_translation lang="pt-br">Fisioterapia</text_translation>
                
                
            </keyword>
            
            <keyword vocabulary="decs" version="" code="E02.779">
                <text>Physical Therapy Modalities</text>
                
                
                <text_translation lang="es">Modalidades de Fisioterapia</text_translation>
                
                <text_translation lang="pt-br">Modalidades de Fisioterapia</text_translation>
                
                
            </keyword>
            

            <freetext>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.</freetext>
        </interventions>

        <recruitment status="recruiting">
            
            <recruitment_country value="BR"></recruitment_country>
            

            <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  </inclusion_criteria>
            <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)</exclusion_criteria>
            <gender value="female"></gender>
            <agemin value="18" unit="years"></agemin>
            <agemax value="45" unit="years"></agemax>

            
            <date_enrolment_actual start="2011-01-02" end="2012-01-06"></date_enrolment_actual>
            

            <target_size value="64"></target_size>
        </recruitment>

        <study expanded_access_program="False"
               number_of_arms="2">
            <study_design>Therapeutic, parallel, with 2 arms, single-blinded, randomized clinical trial.</study_design>
            <type value="Intervention"></type>
            <phase value="null"></phase>
            <purpose value="treatment"></purpose>
            <intervention_assignment value="parallel"></intervention_assignment>
            <masking value="single-blind"></masking>
            <allocation value="randomized-controlled"></allocation>
        </study>

        <outcomes>
            
            <primary_outcome value="Reduction of pain during intercourse after tratamentro with interferential current evaluated by Visual Analog Scale, reported by the patient.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Redução da dor durante a relação sexual após tratamentro com corrente interferencial avaliada pela Escala Análogo Visual, referida pela paciente. " lang="pt-br"></outcome_translation>
                
            </primary_outcome>
            
            <primary_outcome value="Improved sexual function score evaluated by the Female Sexual Function Index;
 Improvement in pain on examination evaluated by visual analog scale">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value="Melhora do score de função sexual avaliado pelo Índice de Função Sexual Feminina; 
Melhora da dor ao exame de toque avaliado pela escala análogo visual" lang="pt-br"></outcome_translation>
                
            </primary_outcome>
            

            
            <secondary_outcome value="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.">
                
                <outcome_translation value="" lang="es"></outcome_translation>
                
                <outcome_translation value=" Melhora do tônus basal intravaginal, da força máxima de contração da musculatura vaginal, e da resistência da musculatura vaginal, avaliados pré e pós tratamento através de análise eletromiográfica (uV) e de pressão (mmHg) com o aparelho Miotool. " lang="pt-br"></outcome_translation>
                
            </secondary_outcome>
            
        </outcomes>

        <contacts>
            
            <person pid="625" country_code="BR">
                <firstname>Paulo </firstname>
                <middlename>César</middlename>
                <lastname>Giraldo</lastname>
                <address>R. Alexander Fleming 101, Cidade Universitária-Barão Geraldo </address>
                <city>Campinas</city>
                <zip>13083-881</zip>
                <telephone>(19)03521.9306</telephone>
                <email>giraldo@unicamp.br</email>
                
                <affiliation country_code="BR" type="higher_education_institution">
                    <name>Faculdade de Ciências Médicas - Universidade Estadual de Campinas</name>
                    <address>Rua: Tessália Vieira de Camargo, 126
 Cidade Universitária &quot;Zeferino Vaz&quot; - Campinas - SP - Brasil - CEP: 13083-887 </address>
                </affiliation>
                
            </person>
            

            
            <public_contact person="625"></public_contact>
            

            
            <scientific_contact person="625"></scientific_contact>
            

            
            <site_contact person="625"></site_contact>
            
        </contacts>

        <secondary_ids>
            
            <secondary_id>
                <sec_id>0024.0.146.000-09</sec_id>
                <issuing_authority>Comitê de Ética em Pesquisa da Faculdade de Ciências Médicas - UNICAMP</issuing_authority>
            </secondary_id>
            
        </secondary_ids>

        <references>
            <link url="http://www.ensaiosclinicos.gov.br/rg/RBR-6z42q3/v1/"></link>
        </references>

        
        
        <translation lang="es">
            <public_title></public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title></scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext></hc_freetext>
            <i_freetext></i_freetext>
            <inclusion_criteria></inclusion_criteria>
            <exclusion_criteria></exclusion_criteria>
            <study_design></study_design>
        </translation>
        
        <translation lang="pt-br">
            <public_title>Avaliação de um tipo de terapia para o tratamento de dor vaginal durante a relação sexual. </public_title>
            <acronym></acronym>
            <acronym_expansion></acronym_expansion>
            <scientific_title>Estimulação elétrica do assoalho pélvico no tratamento de mulheres com dor vulvovaginal crônica</scientific_title>
            <scientific_acronym></scientific_acronym>
            <scientific_acronym_expansion></scientific_acronym_expansion>
            <hc_freetext>Vulvodínia</hc_freetext>
            <i_freetext>Grupo 1 – 32 voluntárias serão submetidas à estimulação elétrica com corrente interferencial (4000Hz, AMF 110HZ, DAMF 60HZ) durante 20 minutos, com a frequência de 1 a 2 vezes por semana, totalizando 8 sessões. 
Grupo 2 – 32 voluntárias serão submetidas ao mesmo protocolo de atendimento ao grupo 1, porém a corrente elétrica não será emitida, sendo o grupo placebo. 
</i_freetext>
            <inclusion_criteria> Dor vulvovaginal crônica há pelo menos 6 meses;
 Confirmação da dor vulvovaginal através do Teste do cotonete e/ou dor vulvovaginal referida e mensurada através da escala análogo visual; 
 Assinatura do termo de consentimento livre e esclarecido </inclusion_criteria>
            <exclusion_criteria>Mulheres que utilizem dispositivo intrauterino;
Gravidez;
Mulheres que utilizem marcapasso;
Mulheres que tenham algum tipo de implante metálico em região de coluna lombar ou quadril;
Mulheres que apresentem doenças neoplásicas;
Mulheres com processo infeccioso agudo em região vulvar;
Imunossupressão crônica;
Deformidade pélvica ou da coluna;
Úlcera genital;
Mulheres em uso de medicações que possam causar mucosite (ex. antibióticos de uso prolongado, imunomoduladores, quimioterápicos);
Mulheres em vigência de quadro alérgicos sistêmicos ou agudos (localizados);
Mulheres que tenham, sabidamente, doença crônica degenerativa (ex. síndrome da imunodeficiência adquirida, transplante renal, lúpus, tuberculose)
</exclusion_criteria>
            <study_design>Ensaio clínico terapêutico, paralelo, com 2 braços, unicego, randomizado</study_design>
        </translation>
        
        
    </trial>
    
</trials>


