<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/NCT03763994</url>
  </required_header>
  <id_info>
    <org_study_id>4385-12</org_study_id>
    <nct_id>NCT03763994</nct_id>
  </id_info>
  <brief_title>Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients</brief_title>
  <official_title>Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Main of the study is to assess the reliability of a new objective tool to measure lumbar&#xD;
      spine motion. The data will be collected from healthy subjects and subjects with frequent or&#xD;
      daily low back pain in the last three months. In addition we compare the results of the&#xD;
      motion measurements with disability and pain questionnaires such as the Roland Morris,&#xD;
      Oswestry Disability Index and the Brief Pain Inventory.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>reliability of measurement tool</measure>
    <time_frame>February 2012-February 2013</time_frame>
    <description>reliability of measurement tool</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Reliability, Validity of Measurement to Assess Lumbar Spine Motion</condition>
  <condition>Comparison of Healthy Subjects and Low Back Pain Patients</condition>
  <arm_group>
    <arm_group_label>Control group 1</arm_group_label>
    <description>Never low back pain in the last 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group 2</arm_group_label>
    <description>occasionally (1-30days) low back pain in the last 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low back pain group 3</arm_group_label>
    <description>frequently (31-60days) low back pain in the last 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low back pain group 4</arm_group_label>
    <description>daily (61-90days) low back pain in the last 3 months</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Low back pain patients were recruited among in-and outpatients of the Department of Pain&#xD;
        Medicine at the Bergmannsheil, Bochum. The subjects of the control groups were recruited by&#xD;
        distributing flyers in sport groups and among hospital staff and friends.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years, informed consent, sufficient German skills &lt;30 days low back pain&#xD;
             in the last 90 days (control group) &gt;31days of low back pain in the last 90 days (low&#xD;
             back pain group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurological disorder (including multiple sclerosis, Stroke, Parkinson´s disease),&#xD;
             Current pain &gt;= 4 (NSR)/intake of analgesic in the last 24h/ previous low back surgery&#xD;
             (control group), inability to perform choreography (LBP group)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Berufsgenossenschaftliches Universitätklinikum Bergmannsheil</name>
      <address>
        <city>Bochum</city>
        <state>Northrine-Westfalia</state>
        <zip>44789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 20, 2012</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Christoph Maier, Prof. Dr.</investigator_full_name>
    <investigator_title>Prof. Dr. Christoph Maier, Pain Medicine</investigator_title>
  </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>
  <!-- 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/NCT03763994
org study id: 4385-12
nct id: NCT03763994
lead sponsor: 
has dmc: No
Main of the study is to assess the reliability of a new objective tool to measure lumbar
      spine motion. The data will be collected from healthy subjects and subjects with frequent or
      daily low back pain in the last three months. In addition we compare the results of the
      motion measurements with disability and pain questionnaires such as the Roland Morris,
      Oswestry Disability Index and the Brief Pain Inventory.
observational model: Case-Control
time perspective: Prospective
measure: reliability of measurement tool
time frame: February 2012-February 2013
description: reliability of measurement tool
arm group label: Control group 1
description: Never low back pain in the last 3 months
arm group label: Control group 2
description: occasionally (1-30days) low back pain in the last 3 months
arm group label: Low back pain group 3
description: frequently (31-60days) low back pain in the last 3 months
arm group label: Low back pain group 4
description: daily (61-90days) low back pain in the last 3 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Christoph Maier, Prof. Dr.
investigator title: Prof. Dr. Christoph Maier, Pain Medicine
mesh term: Back Pain
mesh term: Low Back Pain