<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/NCT02988830</url>
  </required_header>
  <id_info>
    <org_study_id>2016/39</org_study_id>
    <secondary_id>2016-A00991-50</secondary_id>
    <nct_id>NCT02988830</nct_id>
  </id_info>
  <brief_title>Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago</brief_title>
  <acronym>IMESCUT</acronym>
  <official_title>Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in&#xD;
      chronic lumbago after 12 months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 29, 2016</start_date>
  <completion_date type="Actual">January 27, 2022</completion_date>
  <primary_completion_date type="Actual">January 27, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average pain per day on visual analogical scale</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Douleur neuropathique 4 (DN4) score</measure>
    <time_frame>12 months</time_frame>
    <description>DN4 is a French neuropathic pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average pain per day on visual analogical scale</measure>
    <time_frame>15 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OSWESTRY DISABILITY INDEX</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-Item Short Form Health Survey score (SF 36)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DALLAS self-questionnaire</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tampa scale</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire Hospital Anxiety and Depression scale (HAD)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping strategies questionnaire (CSQ)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear Avoidance Belief Questionnaire (FABQ)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Chronic lumbar pain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Subcutaneous Electric Lumbar Stimulation</intervention_name>
    <arm_group_label>Chronic lumbar pain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years old&#xD;
&#xD;
          -  Having given their non-opposition&#xD;
&#xD;
          -  Affiliated to a national insurance scheme or beneficiary&#xD;
&#xD;
          -  Suffering for more than a year from a chronic, invalidating lumbago that is refractory&#xD;
             in several lines of treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with lumbago that can be surgically handled or which justified a medullary&#xD;
             stimulation&#xD;
&#xD;
          -  having been operated for the rachis for less than 6 months;&#xD;
&#xD;
          -  which cannot for cognitive or cultural reasons contribute to the planned evaluations&#xD;
             and to the management of the material (remote control);&#xD;
&#xD;
          -  for who the investigator can plan that they cannot be followed during one year from&#xD;
             the date of the setting-up (non-observance, planned moving, etc.);&#xD;
&#xD;
          -  which present psychological, local or general contraindications to the setting-up of a&#xD;
             neurostimulation device (Impossibility to stop anticoagulants or aggregation&#xD;
             inhibitors, disturb of the hemostasis, cutaneous infection change on the site of&#xD;
             setting-up)&#xD;
&#xD;
          -  MRI planned within the next year&#xD;
&#xD;
          -  pregnant or breast-feeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Christine DJIAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bechir Jarraya, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subcutaneous stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02988830
org study id: 2016/39
secondary id: 2016-A00991-50
nct id: NCT02988830
lead sponsor: 
has dmc: No
The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in
      chronic lumbago after 12 months of treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average pain per day on visual analogical scale
time frame: 12 months
measure: Douleur neuropathique 4 (DN4) score
time frame: 12 months
description: DN4 is a French neuropathic pain scale
measure: Average pain per day on visual analogical scale
time frame: 15 days
measure: OSWESTRY DISABILITY INDEX
time frame: 12 months
measure: 36-Item Short Form Health Survey score (SF 36)
time frame: 12 months
measure: DALLAS self-questionnaire
time frame: 12 months
measure: Tampa scale
time frame: 12 months
measure: Questionnaire Hospital Anxiety and Depression scale (HAD)
time frame: 12 months
measure: Pain Catastrophizing Scale (PCS)
time frame: 12 months
measure: Coping strategies questionnaire (CSQ)
time frame: 12 months
measure: Fear Avoidance Belief Questionnaire (FABQ)
time frame: 12 months
arm group label: Chronic lumbar pain
arm group type: Experimental
intervention type: Device
intervention name: Subcutaneous Electric Lumbar Stimulation
arm group label: Chronic lumbar pain
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Christine DJIAN, MD
role: Principal Investigator
affiliation: Hôpital Foch
last name: Bechir Jarraya, MD, PhD
role: Study Chair
affiliation: Hôpital Foch
facility: 
country: France
responsible party type: Sponsor
mesh term: Low Back Pain
sharing ipd: No