<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/NCT02990585</url>
  </required_header>
  <id_info>
    <org_study_id>041016MP4E</org_study_id>
    <nct_id>NCT02990585</nct_id>
  </id_info>
  <brief_title>Back School for Non-specific Low Back Pain (LBP) in an Urban Setting</brief_title>
  <official_title>The Effect of an 8-session Back School Versus a Single, Abbreviated Session When Looking at Non-specific Low Back Pain in an Urban Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a comparative design between 2 groups of subjects attending classes on&#xD;
      back education in an urban setting. Participants will be randomized to either an individual&#xD;
      one-on-one back school session or to the 8 group sessions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Modified Oswestry Disability Index</measure>
    <time_frame>At 4 weeks, 10 weeks, 4 months, and 7 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion</measure>
    <time_frame>At 4 weeks, 10 weeks, 4 months, and 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Numeric pain rating scale</measure>
    <time_frame>At 4 weeks, 10 weeks, 4 months, and 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the International Physical Activity Questionnaire</measure>
    <time_frame>At 4 weeks, 10 weeks, 4 months, and 7 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>One individual back school session</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 1 individual session will consist of a 60 min 1-on-1 education/exercise session with an athletic trainer. Information will be an abbreviated version of the 8-session school and fill focus on the strengthening, stretching, pain control and movement re-education most needed for the individual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8 group session of back school</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All sessions last 45-60 minutes. There will be up to 8 participants in each session which will be led by an athletic trainer or rehabilitation trainer. Pain management, prevention strategies, and active treatment will be covered in the 8 sessions. Active treatment includes strengthening, stretching, pain control, movement re-education, and walking.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Back school</intervention_name>
    <arm_group_label>8 group session of back school</arm_group_label>
    <arm_group_label>One individual back school session</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants 18 years of age or older who have been suffering from non-specific LBP&#xD;
             for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Additional impairments contraindicating their safe participation in the back school&#xD;
             program, such as evidence of spinal cord pathology, cauda equina, progressive&#xD;
             neurological damage, infection, inflammation, malignancy, fracture or a progressive,&#xD;
             neurodegenerative disease as well as back surgery within the past year&#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 Pepin, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Marie-Eve Pepin</investigator_full_name>
    <investigator_title>Assistant Professor</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>
  <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/NCT02990585
org study id: 041016MP4E
nct id: NCT02990585
lead sponsor: 
has dmc: No
This study will be a comparative design between 2 groups of subjects attending classes on
      back education in an urban setting. Participants will be randomized to either an individual
      one-on-one back school session or to the 8 group sessions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the Modified Oswestry Disability Index
time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
measure: Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
measure: Change in the Numeric pain rating scale
time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
measure: Change in the International Physical Activity Questionnaire
time frame: At 4 weeks, 10 weeks, 4 months, and 7 months
arm group label: One individual back school session
arm group type: Active Comparator
description: The 1 individual session will consist of a 60 min 1-on-1 education/exercise session with an athletic trainer. Information will be an abbreviated version of the 8-session school and fill focus on the strengthening, stretching, pain control and movement re-education most needed for the individual.
arm group label: 8 group session of back school
arm group type: Active Comparator
description: All sessions last 45-60 minutes. There will be up to 8 participants in each session which will be led by an athletic trainer or rehabilitation trainer. Pain management, prevention strategies, and active treatment will be covered in the 8 sessions. Active treatment includes strengthening, stretching, pain control, movement re-education, and walking.
intervention type: Other
intervention name: Back school
arm group label: 8 group session of back school
arm group label: One individual back school session
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie Pepin, DPT
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Marie-Eve Pepin
investigator title: Assistant Professor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No