<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/NCT01701427</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2012-035</org_study_id>
    <nct_id>NCT01701427</nct_id>
  </id_info>
  <brief_title>Pain After Deep Electrical Stimulation in the Groin in Pain Free Subjects</brief_title>
  <acronym>HADES-1</acronym>
  <official_title>Hyperalgesia After Deep Electrical Stimulation in Pain Free Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper&#xD;
      structures as well as the skin. Whether this is one combined pain syndrome, where for&#xD;
      instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain&#xD;
      conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical&#xD;
      stimulation in deeper tissues in the groin and recording the skin sensory function, this&#xD;
      hypothesis will be tested&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in skin pain detection threshold before and during deep electrical pain stimulation.</measure>
    <time_frame>14 days</time_frame>
    <description>Heat pain detection threshold by use of a Thermotester (Somedic AS Sweden) is assessed before and during deep electrical pain stimulation (6 of 10 point on a NRS scale. Deep pain stimulation is performed by two needle electrodes, placed under ultrasound guidance, 5 mm apart in various tissue and locations in the groin:&#xD;
Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.&#xD;
Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation.&#xD;
External inguinal ring - subcutaneous and funicle stimulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test-retest of primary outcome</measure>
    <time_frame>14 days</time_frame>
    <description>The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>deep electrical and pain detection thresholds</measure>
    <time_frame>14 days</time_frame>
    <description>The detection- and pain detection thresholds to electrical stimulation will be assessed. An up-n-down staircase stimulation of single oulses of 0.04 mSeconds with increasing mA from 0.1 to a maximum of 60 mA is used. A total of 10 thresholds is recorded in the following locations.&#xD;
Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.&#xD;
Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation.&#xD;
External inguinal ring - subcutaneous and funicle stimulation. Musculus rectus abdominis sin. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.</description>
  </other_outcome>
  <other_outcome>
    <measure>warmth and mechanical detection and pain detection thresholds</measure>
    <time_frame>14 days</time_frame>
    <description>warmth and mechanical detection and pain detection thresholds are recorded in the right and left groin and right lower arm. A total of 10 repated mesures for each parameter is recorded.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Persistent Postherniotomy Pain</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy young men.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male, age &gt;18 yr, pain-free, caucasian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous groin surgery, groin hernia, sensory disturbaces, use of painmedication, drug&#xD;
             or alcohol abuse.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Section for Surgical Pathophysiology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>January 4, 2013</last_update_submitted>
  <last_update_submitted_qc>January 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Eske Kvanner Aasvang</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Hyperalgesia</keyword>
  <keyword>Persistent pain</keyword>
  <keyword>deep pain</keyword>
  <keyword>electrical stimulation</keyword>
  <keyword>groin hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperalgesia</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/NCT01701427
org study id: H-1-2012-035
nct id: NCT01701427
lead sponsor: 
has dmc: No
Sensory disturbances in persistent postherniotomy pain, include hyperalgesia from deeper
      structures as well as the skin. Whether this is one combined pain syndrome, where for
      instance deep pain leads to cutaneous hyperalgesia, or two isolated synchronous pain
      conditions, is unknown. By Giving pain free subjects an intense non-harmful electrical
      stimulation in deeper tissues in the groin and recording the skin sensory function, this
      hypothesis will be tested
observational model: Cohort
time perspective: Prospective
measure: Change in skin pain detection threshold before and during deep electrical pain stimulation.
time frame: 14 days
description: Heat pain detection threshold by use of a Thermotester (Somedic AS Sweden) is assessed before and during deep electrical pain stimulation (6 of 10 point on a NRS scale. Deep pain stimulation is performed by two needle electrodes, placed under ultrasound guidance, 5 mm apart in various tissue and locations in the groin:
Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.
Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation.
External inguinal ring - subcutaneous and funicle stimulation.
measure: Test-retest of primary outcome
time frame: 14 days
description: The primay and additional assesments are re-measured 14 days after the primary assemssment to allow evaluation of test-retest reliability.
measure: deep electrical and pain detection thresholds
time frame: 14 days
description: The detection- and pain detection thresholds to electrical stimulation will be assessed. An up-n-down staircase stimulation of single oulses of 0.04 mSeconds with increasing mA from 0.1 to a maximum of 60 mA is used. A total of 10 thresholds is recorded in the following locations.
Musculus rectus abdominis dxt. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.
Spina iliaca anterior superior dxt. ( 2 cm lateral to the ilica spine) - subcutaneous, m obliquus externus and nervns ilioinguinalis stimulation.
External inguinal ring - subcutaneous and funicle stimulation. Musculus rectus abdominis sin. ( 10 cm craniel to the external inguinal ring) - Subcutaneous, and muscular stimulation.
measure: warmth and mechanical detection and pain detection thresholds
time frame: 14 days
description: warmth and mechanical detection and pain detection thresholds are recorded in the right and left groin and right lower arm. A total of 10 repated mesures for each parameter is recorded.
arm group label: 1
description: 1. Healthy, un-operated, groin-hernia free, pain-free and medicinal free males
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Eske Kvanner Aasvang
investigator title: M.D.
mesh term: Hyperalgesia