<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02205970</url>
  </required_header>
  <id_info>
    <org_study_id>UFSaoCarlos0001/14</org_study_id>
    <secondary_id>036/2010</secondary_id>
    <nct_id>NCT02205970</nct_id>
  </id_info>
  <brief_title>Application of Electrical Neurostimulation Transcutaneous in Patients With Primary Dysmenorrhea.</brief_title>
  <official_title>Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study Between Proposed Method of Application Versus Traditional Method in Patients With Primary Dysmenorrhea).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Sao Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Sao Carlos</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study aims to verify the analgesic potential of a new methodological proposal for&#xD;
      application for transcutaneous electrical nerve stimulation (TENS interactive) using patients&#xD;
      with primary dysmenorrhoea and compare it with placebo in a randomized double blind study&#xD;
      with convenience sample.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The denouement will be the intensity of pain from visual analogue scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>one arm study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application</measure>
    <time_frame>participants will be monitored for 24 hours</time_frame>
    <description>To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of analgesia after application</measure>
    <time_frame>1 week</time_frame>
    <description>check the duration of analgesia after application of interactive TENS (proposed method)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Primary Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>TENS active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TENS sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Placebo lasting 35 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.</description>
    <arm_group_label>TENS active</arm_group_label>
    <other_name>TENS - eletric pulse generator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS (sham)</intervention_name>
    <description>In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.</description>
    <arm_group_label>TENS sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary dysmenorrhoea&#xD;
&#xD;
          -  Moderate to severe pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary dysmenorrhea&#xD;
&#xD;
          -  Users of intrauterine device&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Failure to appear for treatment&#xD;
&#xD;
          -  Pacemaker use&#xD;
&#xD;
          -  Illicit drug use&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Skin problems&#xD;
&#xD;
          -  Use of pain medication before the application of TENS&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fábio M. Camilo, teacher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundação de Educação e Cultura de Santa Fé do Sul</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Sao Carlos</investigator_affiliation>
    <investigator_full_name>Fabio Mendes Camilo</investigator_full_name>
    <investigator_title>Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study between Proposed Method of Application Versus Traditional method in patients with Primary Dysmenorrhea).</investigator_title>
  </responsible_party>
  <keyword>TENS</keyword>
  <keyword>Dysmenorrhea</keyword>
  <keyword>analgesia</keyword>
  <keyword>interactive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02205970
org study id: UFSaoCarlos0001/14
secondary id: 036/2010
nct id: NCT02205970
lead sponsor: 
has dmc: No
The present study aims to verify the analgesic potential of a new methodological proposal for
      application for transcutaneous electrical nerve stimulation (TENS interactive) using patients
      with primary dysmenorrhoea and compare it with placebo in a randomized double blind study
      with convenience sample.
The denouement will be the intensity of pain from visual analogue scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: one arm study
measure: measure the pain threshold, used to Visual Analogue Scale (VAS)before and after application
time frame: participants will be monitored for 24 hours
description: To assess pain intensity, will be used to Visual Analogue Scale (VAS), Assessments with EVA are performed before and after treatment of interactive TENS (proposed method). All selected volunteers were subjected to an application of TENS (active or sham) in a single menstrual cycle.
measure: duration of analgesia after application
time frame: 1 week
description: check the duration of analgesia after application of interactive TENS (proposed method)
arm group label: TENS active
arm group type: Active Comparator
description: TENS (interactive): frequency (90 and 150 pps) and pulse duration (300 and 400μs)
arm group label: TENS sham
arm group type: Sham Comparator
description: Placebo lasting 35 minutes.
intervention type: Device
intervention name: TENS
description: In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.
arm group label: TENS active
other name: TENS - eletric pulse generator
intervention type: Device
intervention name: TENS (sham)
description: In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.
arm group label: TENS sham
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 36 Years
healthy volunteers: No
last name: Fábio M. Camilo, teacher
role: Principal Investigator
affiliation: Fundação de Educação e Cultura de Santa Fé do Sul
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Sao Carlos
investigator full name: Fabio Mendes Camilo
investigator title: Methodological Proposal of Application of Electrical Neurostimulation Transcutaneous (Comparative Study between Proposed Method of Application Versus Traditional method in patients with Primary Dysmenorrhea).
mesh term: Dysmenorrhea