<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/NCT02226692</url>
  </required_header>
  <id_info>
    <org_study_id>UQTR-2011-PFAC</org_study_id>
    <nct_id>NCT02226692</nct_id>
  </id_info>
  <brief_title>Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain</brief_title>
  <official_title>Risk of Poor Prognosis in Patients With Chronic Low Back Pain : Can it be Predicted by Physical Tests and Screening Tools ? - An Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université du Québec à Trois-Rivières</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fonds de la Recherche en Santé du Québec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université du Québec à Trois-Rivières</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to quantify the relative contribution of variables obtained&#xD;
      during a physical fitness evaluation and a short screening questionnaire in determining the&#xD;
      short-term and long term risk of persistent disabling low back pain in patients with chronic&#xD;
      low back pain. It has been hypothesized that patients with higher physical fitness will&#xD;
      present a lower risk of persistent disabling low back pain and so, a lower score on the&#xD;
      questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</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>Disability level</measure>
    <time_frame>2 months</time_frame>
    <description>Oswestry disability index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability level</measure>
    <time_frame>4 months</time_frame>
    <description>Oswestry disability index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability level</measure>
    <time_frame>6 months</time_frame>
    <description>Oswestry disability index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disability level</measure>
    <time_frame>12 months</time_frame>
    <description>Oswestry disability index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in the past 2 months</measure>
    <time_frame>2 months</time_frame>
    <description>101 points numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement level</measure>
    <time_frame>2 months</time_frame>
    <description>Tampa scale for kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's global impression of change from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Patient's global impression of change scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's global impression of change from 6 months</measure>
    <time_frame>12 months</time_frame>
    <description>Patient's global impression of change scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in the past 2 months</measure>
    <time_frame>4 months</time_frame>
    <description>101 points numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in the past 2 months</measure>
    <time_frame>6 months</time_frame>
    <description>101 points numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in the past 6 months</measure>
    <time_frame>12 months</time_frame>
    <description>101 points numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity in the past week</measure>
    <time_frame>12 months</time_frame>
    <description>101 points numerical rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement level</measure>
    <time_frame>4 months</time_frame>
    <description>Tampa scale for kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement level</measure>
    <time_frame>6 months</time_frame>
    <description>Tampa scale for kinesiophobia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement level</measure>
    <time_frame>12 months</time_frame>
    <description>Tampa scale for kinesiophobia</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <condition>Mechanical Low Back Pain</condition>
  <arm_group>
    <arm_group_label>nonspecific chronic low back pain</arm_group_label>
    <description>Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        volunteer with chronic nonspecific low back pain will be recruited among the university's&#xD;
        community, its outpatients' chiropractic clinic and through advertisements in the local&#xD;
        newspaper. They will first be screened by clinicians at the outpatients' chiropractic&#xD;
        clinic in order to assess for the various inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults between 18 and 60 years old&#xD;
&#xD;
          -  nonspecific low back pain : pain located between the twelfth rib and the inferior&#xD;
             gluteal fold for which no specific source of pain could be identified&#xD;
&#xD;
          -  chronic low back pain : pain present for 12 weeks or more, and included both constant&#xD;
             and recurrent patterns of pain&#xD;
&#xD;
          -  able to read and understand French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of surgery or major trauma to the spine&#xD;
&#xD;
          -  Current use of medication known to impair physical effort and pain perception&#xD;
&#xD;
          -  Lumbar scoliosis of more than 20°&#xD;
&#xD;
          -  Collagenosis, severe osteoporosis&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Malignant tumor&#xD;
&#xD;
          -  Non-controlled hypertension&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Radiculopathy&#xD;
&#xD;
          -  Progressive neurologic defect&#xD;
&#xD;
          -  Myelopathy&#xD;
&#xD;
          -  Lumbar disc hernia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active lower body injury and/or severe and disabling pain limiting the capacity to&#xD;
             undergo the evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Descarreaux, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université du Québec à Trois-Rivières</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Université du Québec à Trois-Rivières</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G9A 5H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>May 26, 2015</last_update_submitted>
  <last_update_submitted_qc>May 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université du Québec à Trois-Rivières</investigator_affiliation>
    <investigator_full_name>Martin Descarreaux</investigator_full_name>
    <investigator_title>Dr Martin Descarreaux DC, PhD</investigator_title>
  </responsible_party>
  <keyword>chronic low back pain</keyword>
  <keyword>prognostic factors</keyword>
  <keyword>disabling low back pain</keyword>
  <keyword>lumbar muscle activity</keyword>
  <keyword>start back screening tool</keyword>
  <keyword>physical evaluation</keyword>
  <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/NCT02226692
org study id: UQTR-2011-PFAC
nct id: NCT02226692
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The aim of the present study is to quantify the relative contribution of variables obtained
      during a physical fitness evaluation and a short screening questionnaire in determining the
      short-term and long term risk of persistent disabling low back pain in patients with chronic
      low back pain. It has been hypothesized that patients with higher physical fitness will
      present a lower risk of persistent disabling low back pain and so, a lower score on the
      questionnaire.
observational model: Cohort
time perspective: Prospective
measure: Disability level
time frame: 2 months
description: Oswestry disability index
measure: Disability level
time frame: 4 months
description: Oswestry disability index
measure: Disability level
time frame: 6 months
description: Oswestry disability index
measure: Disability level
time frame: 12 months
description: Oswestry disability index
measure: Pain intensity in the past 2 months
time frame: 2 months
description: 101 points numerical rating scale
measure: Fear of movement level
time frame: 2 months
description: Tampa scale for kinesiophobia
measure: Patient's global impression of change from baseline
time frame: 6 months
description: Patient's global impression of change scale
measure: Patient's global impression of change from 6 months
time frame: 12 months
description: Patient's global impression of change scale
measure: Pain intensity in the past 2 months
time frame: 4 months
description: 101 points numerical rating scale
measure: Pain intensity in the past 2 months
time frame: 6 months
description: 101 points numerical rating scale
measure: Pain intensity in the past 6 months
time frame: 12 months
description: 101 points numerical rating scale
measure: Pain intensity in the past week
time frame: 12 months
description: 101 points numerical rating scale
measure: Fear of movement level
time frame: 4 months
description: Tampa scale for kinesiophobia
measure: Fear of movement level
time frame: 6 months
description: Tampa scale for kinesiophobia
measure: Fear of movement level
time frame: 12 months
description: Tampa scale for kinesiophobia
arm group label: nonspecific chronic low back pain
description: Physical examination and follow-up assessment by questionnaires at 2, 4, 6, and 12 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Martin Descarreaux, PhD
role: Principal Investigator
affiliation: Université du Québec à Trois-Rivières
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université du Québec à Trois-Rivières
investigator full name: Martin Descarreaux
investigator title: Dr Martin Descarreaux DC, PhD
mesh term: Back Pain
mesh term: Low Back Pain