<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/NCT04419675</url>
  </required_header>
  <id_info>
    <org_study_id>109643</org_study_id>
    <nct_id>NCT04419675</nct_id>
  </id_info>
  <brief_title>The Course of Low Back Pain</brief_title>
  <official_title>The Course of Low Back Pain: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</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>
      This study aims to research the possible associations of education level, sedentary&#xD;
      lifestyle, and type of low back pain (radicular vs non-radicular) with the course of low back&#xD;
      pain and recovery rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Functional Limitations</measure>
    <time_frame>Measurement at baseline</time_frame>
    <description>Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Limitations</measure>
    <time_frame>Measurement at 6 weeks</time_frame>
    <description>Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Limitations</measure>
    <time_frame>Measurement at 12 weeks</time_frame>
    <description>Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Limitations</measure>
    <time_frame>Measurement at 26 weeks</time_frame>
    <description>Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional Limitations</measure>
    <time_frame>Measurement at 52 weeks</time_frame>
    <description>Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery rate</measure>
    <time_frame>26 weeks after inclusion</time_frame>
    <description>Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery rate</measure>
    <time_frame>52 weeks after inclusion</time_frame>
    <description>Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain with Numeric Pain Rating Scale</measure>
    <time_frame>measurement at baseline</time_frame>
    <description>Numeric Pain Rating Scale (0= no pain, 10= maximum pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain with Numeric Pain Rating Scale</measure>
    <time_frame>measurement at 6 weeks</time_frame>
    <description>Numeric Pain Rating Scale (0= no pain, 10= maximum pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain with Numeric Pain Rating Scale</measure>
    <time_frame>measurement at 12 weeks</time_frame>
    <description>Numeric Pain Rating Scale (0= no pain, 10= maximum pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain with Numeric Pain Rating Scale</measure>
    <time_frame>measurement at 26 weeks</time_frame>
    <description>Numeric Pain Rating Scale (0= no pain, 10= maximum pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain with Numeric Pain Rating Scale</measure>
    <time_frame>measurement at 52 weeks</time_frame>
    <description>Numeric Pain Rating Scale (0= no pain, 10= maximum pain)</description>
  </primary_outcome>
  <enrollment type="Actual">347</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Type of Leg Pain (Radicular, Non-radicular)</condition>
  <condition>Lifestyle (Sedentary Behavior and Physical Activity)</condition>
  <condition>Start Back Screening Tool</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational Cohort, usual care = physical therapy</intervention_name>
    <description>usual care = physical therapy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People with low back pain contacting physical therapy for treatment of low back pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low back pain&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fysius Amersfoort</name>
      <address>
        <city>Amersfoort</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysius Arnhem</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysius Eindhoven</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysius Nijmegen</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysius Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fysius Winterswijk</name>
      <address>
        <city>Winterswijk</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Storage at central data storage of Radboud University Medical Center</ipd_description>
  </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/NCT04419675
org study id: 109643
nct id: NCT04419675
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to research the possible associations of education level, sedentary
      lifestyle, and type of low back pain (radicular vs non-radicular) with the course of low back
      pain and recovery rate.
observational model: Cohort
time perspective: Prospective
measure: Functional Limitations
time frame: Measurement at baseline
description: Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
measure: Functional Limitations
time frame: Measurement at 6 weeks
description: Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
measure: Functional Limitations
time frame: Measurement at 12 weeks
description: Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
measure: Functional Limitations
time frame: Measurement at 26 weeks
description: Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
measure: Functional Limitations
time frame: Measurement at 52 weeks
description: Measured with Patient Specific Scale (0=no limitation, 100=impossible to perform) and Oswestry Disability Index (0=no limitation, 100=very limited)
measure: Recovery rate
time frame: 26 weeks after inclusion
description: Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)
measure: Recovery rate
time frame: 52 weeks after inclusion
description: Global Perceived Effect (7-point Likert-scale where 0=much worse, 7=completely recovered)
measure: Pain with Numeric Pain Rating Scale
time frame: measurement at baseline
description: Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measure: Pain with Numeric Pain Rating Scale
time frame: measurement at 6 weeks
description: Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measure: Pain with Numeric Pain Rating Scale
time frame: measurement at 12 weeks
description: Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measure: Pain with Numeric Pain Rating Scale
time frame: measurement at 26 weeks
description: Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
measure: Pain with Numeric Pain Rating Scale
time frame: measurement at 52 weeks
description: Numeric Pain Rating Scale (0= no pain, 10= maximum pain)
intervention type: Other
intervention name: Observational Cohort, usual care = physical therapy
description: usual care = physical therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided
ipd description: Storage at central data storage of Radboud University Medical Center