<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/NCT03303300</url>
  </required_header>
  <id_info>
    <org_study_id>5RSTS</org_study_id>
    <nct_id>NCT03303300</nct_id>
  </id_info>
  <brief_title>The Five-repetition Sit-to-stand Test for Lower Back Pain or Radiculopathy</brief_title>
  <acronym>5R-STS</acronym>
  <official_title>The Five-repetition Sit-to-stand Test as an Objective Measure of Functional Impairment in Patients With Lower Back Pain or Radiculopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marc Schröder</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bergman Clinics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but&#xD;
      has never been correlated with or validated in regard to degenerative spinal diseases. The&#xD;
      investigators aim to assess the possibility of using the standardized 5R-STS as an objective&#xD;
      measure of functional impairment and pain severity in patients with degenerative lumbar&#xD;
      spinal diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 3, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</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>5R-STS</measure>
    <time_frame>0 weeks</time_frame>
    <description>The result of the standardized 5R-STS in seconds. If the patient is unable to complete the test, the results is noted as &quot;not possible&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS back pain</measure>
    <time_frame>0 weeks</time_frame>
    <description>Validated questionnaire (VAS BP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS leg pain</measure>
    <time_frame>0 weeks</time_frame>
    <description>Validated questionnaire (VAS LP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D-3L</measure>
    <time_frame>0 weeks</time_frame>
    <description>Validated questionnaire (EQ-5D-3L) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index</measure>
    <time_frame>0 weeks</time_frame>
    <description>Validated questionnaire (ODI) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roland-Morris-Disability Questionnaire</measure>
    <time_frame>0 weeks</time_frame>
    <description>Validated questionnaire (RMDBQ) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.</description>
  </secondary_outcome>
  <enrollment type="Actual">237</enrollment>
  <condition>Degenerative Disc Disease</condition>
  <condition>Degenerative Spondylolisthesis</condition>
  <condition>Herniated Disc</condition>
  <condition>Stenosis, Spinal</condition>
  <condition>Nerve Root Compress;Lumbosac</condition>
  <eligibility>
    <study_pop>
      <textblock>
        100 patients with degenerative lumbar spinal diseases that are seen in outpatient&#xD;
        consultations will be recruited. All tests and questionnaires are part of the normal&#xD;
        clinical assessment of the study center; The patients are thus not required to make any&#xD;
        extra efforts.&#xD;
&#xD;
        25 healthy volunteers (the authors and volunteers from the department) will be included to&#xD;
        get baseline data for the 5R-STS in healthy people&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        This study will include 100 Patients:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis,&#xD;
             spondylolisthesis, degenerative disc disease)&#xD;
&#xD;
          -  Symptoms of lower back pain, neurogenic claudication, or radiculopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hip or Knee prosthetics&#xD;
&#xD;
          -  Walking aides&#xD;
&#xD;
        This study will also include 25 healthy volunteers:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - No degenerative spinal or lower extremity complaints&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Back pain, leg pain, other lower extremity-related complaints&#xD;
&#xD;
          -  Knee or hip prosthetics&#xD;
&#xD;
          -  Walking aides&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neurosurgery, Bergman Clinics</name>
      <address>
        <city>Naarden</city>
        <zip>1411 GE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>December 3, 2017</last_update_submitted>
  <last_update_submitted_qc>December 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bergman Clinics</investigator_affiliation>
    <investigator_full_name>Marc Schröder</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    <mesh_term>Spondylolisthesis</mesh_term>
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Radiculopathy</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT03303300
org study id: 5RSTS
nct id: NCT03303300
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The five-repetition sit-to-stand test (5R-STS) has been used in many medical disciplines, but
      has never been correlated with or validated in regard to degenerative spinal diseases. The
      investigators aim to assess the possibility of using the standardized 5R-STS as an objective
      measure of functional impairment and pain severity in patients with degenerative lumbar
      spinal diseases.
observational model: Cohort
time perspective: Prospective
measure: 5R-STS
time frame: 0 weeks
description: The result of the standardized 5R-STS in seconds. If the patient is unable to complete the test, the results is noted as "not possible".
measure: VAS back pain
time frame: 0 weeks
description: Validated questionnaire (VAS BP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
measure: VAS leg pain
time frame: 0 weeks
description: Validated questionnaire (VAS LP) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
measure: EQ-5D-3L
time frame: 0 weeks
description: Validated questionnaire (EQ-5D-3L) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
measure: Oswestry Disability Index
time frame: 0 weeks
description: Validated questionnaire (ODI) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
measure: Roland-Morris-Disability Questionnaire
time frame: 0 weeks
description: Validated questionnaire (RMDBQ) will be used to correlate the 5R-STS results with validated measures of functional impairment and pain severity.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: Bergman Clinics
investigator full name: Marc Schröder
investigator title: MD, PhD
mesh term: Intervertebral Disc Degeneration
mesh term: Spondylolisthesis
mesh term: Intervertebral Disc Displacement
mesh term: Spinal Stenosis
mesh term: Radiculopathy
mesh term: Back Pain
mesh term: Low Back Pain