<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/NCT03761316</url>
  </required_header>
  <id_info>
    <org_study_id>LEISURE</org_study_id>
    <nct_id>NCT03761316</nct_id>
  </id_info>
  <brief_title>Goal Setting in SCS Patients: a Qualitative Review</brief_title>
  <official_title>Goal Setting in SCS Patients: a Qualitative Review (LEISURE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moens Maarten</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study in which the investigators will describe individual goals of&#xD;
      patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Goals and expectations towards spinal cord stimulation</measure>
    <time_frame>Before spinal cord stimulation implantation</time_frame>
    <description>Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <arm_group>
    <arm_group_label>FBSS patients</arm_group_label>
    <description>patients with Failed Back Surgery Syndrome, eligible for SCS</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>interview regarding goals</intervention_name>
    <description>interview regarding goals</description>
    <arm_group_label>FBSS patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with medication-resistant chronic back and leg pain due to Failed Back Surgery&#xD;
        Syndrome who are offered treatment with SCS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic pain as a result of FBSS that exists for at least 6 months with a pain&#xD;
             intensity 5 or higher measured on numeric rating scale (NRS)&#xD;
&#xD;
          -  FBSS patients suitable for SCS&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Native Dutch or French speeking patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Expected inability of patients to receive or properly operate the spinal cord&#xD;
             stimulation system&#xD;
&#xD;
          -  History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid&#xD;
             arthritis or morbus Bechterew&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Addiction to any of the following drugs, alcohol (5E/day) and/or medication&#xD;
&#xD;
          -  Evidence of an active disruptive psychiatric disorder or other known condition&#xD;
             significant enough to impact perception of pain, compliance to intervention and/or&#xD;
             ability to evaluate treatment outcome as determined by investigator&#xD;
&#xD;
          -  Immune deficiency (HIV positive, immunosuppressiva, etc.)&#xD;
&#xD;
          -  Life expectancy &lt; 1 year&#xD;
&#xD;
          -  Local infection or other skin disorder at site of incision&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Other implanted active medical device&#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>Maarten Moens, Prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <state>Brussel</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Moens Maarten</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Spinal cord stimulation</keyword>
  <keyword>interview</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Failed Back Surgery Syndrome</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/NCT03761316
org study id: LEISURE
nct id: NCT03761316
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective study in which the investigators will describe individual goals of
      patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Goals and expectations towards spinal cord stimulation
time frame: Before spinal cord stimulation implantation
description: Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview
arm group label: FBSS patients
description: patients with Failed Back Surgery Syndrome, eligible for SCS
intervention type: Other
intervention name: interview regarding goals
description: interview regarding goals
arm group label: FBSS patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maarten Moens, Prof. dr.
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Moens Maarten
investigator title: Prof. dr.
mesh term: Failed Back Surgery Syndrome