<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/NCT01662934</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH_GO_004</org_study_id>
    <nct_id>NCT01662934</nct_id>
  </id_info>
  <brief_title>A Randomized, Sham Device Controlled, Single Blinded Trial of Portable Transcutaneous Electrical Nerve Stimulation and Heat Therapy Machine in Women With Dysmenorrhea</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine&#xD;
      could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score&#xD;
      before and after use of TENS and heat therapy machine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">April 2013</primary_completion_date>
  <phase>Phase 3</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of VAS before and after application of machine</measure>
    <time_frame>Immediately before application of machine and 20minutes after application of machine</time_frame>
    <description>Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BPI score</measure>
    <time_frame>2nd day of menstrual cycle</time_frame>
    <description>Brief Pain Inventory score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">118</enrollment>
  <condition>Dysmenorrhea</condition>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Using not functioning device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using functioning device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I RUNE</intervention_name>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Transcutaneous electrical nerve stimulation and heat therapy machine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham</intervention_name>
    <arm_group_label>Sham</arm_group_label>
    <other_name>sham device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion&#xD;
&#xD;
          -  Age&gt;19&#xD;
&#xD;
          -  Premenopausal&#xD;
&#xD;
          -  Moderate or severe dysmenorrhea, mainly in low abdomen area&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Surgery history on lower abdomen&#xD;
&#xD;
          -  Recent history of cancer&#xD;
&#xD;
          -  TENS device use is contraindicated&#xD;
&#xD;
          -  Ibuprofen use is contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam Si</city>
        <state>Gyenggi Do</state>
        <zip>463707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <last_update_submitted>March 14, 2013</last_update_submitted>
  <last_update_submitted_qc>March 14, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dysmenorrhea</keyword>
  <keyword>transcutaneous electrical nerve stimulation</keyword>
  <keyword>heat therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>May 14, 2013</submitted>
    <returned>July 1, 2013</returned>
    <submitted>October 29, 2017</submitted>
    <returned>August 1, 2018</returned>
  </pending_results>
  <!-- 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/NCT01662934
org study id: SNUBH_GO_004
nct id: NCT01662934
lead sponsor: 
has dmc: Yes
The hypothesis is that a transcutaneous electrical nerve stimulation and heat therapy machine
      could reduce dysmenorrhea in women with primary or secondary dysmenorrhea.
Inclusion/Exclusion: Described in Eligibility section. Outcome measures: Change of VAS score
      before and after use of TENS and heat therapy machine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change of VAS before and after application of machine
time frame: Immediately before application of machine and 20minutes after application of machine
description: Measure the change% of VAS between before application of machine (T0) and 20 minutes after application of machine (T20) in every episode of dysmenorrhea during 1 menstrual cycle The mean of change% of VAS is primary outcome measure
measure: BPI score
time frame: 2nd day of menstrual cycle
description: Brief Pain Inventory score
arm group label: Sham
arm group type: Sham Comparator
description: Using not functioning device
arm group label: Experimental
arm group type: Experimental
description: Using functioning device
intervention type: Device
intervention name: I RUNE
arm group label: Experimental
other name: Transcutaneous electrical nerve stimulation and heat therapy machine
intervention type: Device
intervention name: sham
arm group label: Sham
other name: sham device
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dysmenorrhea
submitted: May 14, 2013
returned: July 1, 2013
submitted: October 29, 2017
returned: August 1, 2018