<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/NCT03301428</url>
  </required_header>
  <id_info>
    <org_study_id>CLBP EDUC</org_study_id>
    <nct_id>NCT03301428</nct_id>
  </id_info>
  <brief_title>Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability</brief_title>
  <official_title>Effectiveness of Different Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability in Patients With Chronic Low Back Pain: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Liege</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Liege</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 trial aims at comparing the effectiveness of different didactic tools developed for&#xD;
      patients with chronic pain to correct misbeliefs and improve disability in patients with&#xD;
      chronic low back pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial aims at comparing the effectiveness of different didactic tools (an educational&#xD;
      website vs a booklet) developed for patients with chronic pain to correct misbeliefs and&#xD;
      improve disability in patients with chronic low back pain.&#xD;
&#xD;
      Participants of the 2 experimental groups will be invited to use the tool they receive during&#xD;
      a one-month period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Beliefs Questionnaire</measure>
    <time_frame>Change from baseline to the three-month follow-up</time_frame>
    <description>Questionnaires to test patients' beliefs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Roland-Morris Disability Questionnaire</measure>
    <time_frame>Change from baseline to the three-month follow-up</time_frame>
    <description>Disability questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief-Illness Perception Questionnaire</measure>
    <time_frame>Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up</time_frame>
    <description>Questionnaire about patients' beliefs/representations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Back-PAQ questionnaire</measure>
    <time_frame>Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up</time_frame>
    <description>Questionnaire about patients' beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up</time_frame>
    <description>Pain Numeric rating scale</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Beliefs</condition>
  <condition>Disability Physical</condition>
  <arm_group>
    <arm_group_label>Retrain pain educational website</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be invited to consult an educational website developped for patients with chronic pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Booklet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be invited to read an educational booklet for patients with chronic pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this group will receive the 2 educational tools at the end of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retrain pain educational website</intervention_name>
    <description>Patients in this group will be invited to consult an educational website developped for patients with chronic pain</description>
    <arm_group_label>Retrain pain educational website</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Booklet</intervention_name>
    <description>Patients in this group will be invited toread an educational booklet developped for patients with chronic pain</description>
    <arm_group_label>Booklet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals with non-specific persistent low back pain (pain &gt; 6 months) who had their&#xD;
             pain assessed by their general practitioner or a specialist within the last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  specific low back pain,&#xD;
&#xD;
          -  educational treatment (back school, cognitive-behavioral, pain neurosciences&#xD;
             education) in progress or planned during the study period&#xD;
&#xD;
          -  previous consultation of the didactic tools investigated in the present study&#xD;
&#xD;
          -  nerve root compromise,&#xD;
&#xD;
          -  recent spinal surgery (&lt;3 months)&#xD;
&#xD;
          -  not fluent in French&#xD;
&#xD;
          -  no regular access to a computer and the internet&#xD;
&#xD;
          -  present follow-up by a psychiatrist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe Demoulin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liege University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liege University Hospital</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>March 24, 2020</last_update_submitted>
  <last_update_submitted_qc>March 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Liege</investigator_affiliation>
    <investigator_full_name>Christophe Demoulin</investigator_full_name>
    <investigator_title>Invited Professor</investigator_title>
  </responsible_party>
  <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/NCT03301428
org study id: CLBP EDUC
nct id: NCT03301428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial aims at comparing the effectiveness of different didactic tools developed for
      patients with chronic pain to correct misbeliefs and improve disability in patients with
      chronic low back pain
This trial aims at comparing the effectiveness of different didactic tools (an educational
      website vs a booklet) developed for patients with chronic pain to correct misbeliefs and
      improve disability in patients with chronic low back pain.

      Participants of the 2 experimental groups will be invited to use the tool they receive during
      a one-month period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain Beliefs Questionnaire
time frame: Change from baseline to the three-month follow-up
description: Questionnaires to test patients' beliefs
measure: Roland-Morris Disability Questionnaire
time frame: Change from baseline to the three-month follow-up
description: Disability questionnaire
measure: Brief-Illness Perception Questionnaire
time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
description: Questionnaire about patients' beliefs/representations
measure: Back-PAQ questionnaire
time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
description: Questionnaire about patients' beliefs
measure: Pain intensity
time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
description: Pain Numeric rating scale
arm group label: Retrain pain educational website
arm group type: Experimental
description: Participants will be invited to consult an educational website developped for patients with chronic pain
arm group label: Booklet
arm group type: Experimental
description: Participants will be invited to read an educational booklet for patients with chronic pain
arm group label: Control
arm group type: No Intervention
description: Participants in this group will receive the 2 educational tools at the end of the study
intervention type: Other
intervention name: Retrain pain educational website
description: Patients in this group will be invited to consult an educational website developped for patients with chronic pain
arm group label: Retrain pain educational website
intervention type: Other
intervention name: Booklet
description: Patients in this group will be invited toread an educational booklet developped for patients with chronic pain
arm group label: Booklet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Christophe Demoulin
role: Principal Investigator
affiliation: Liege University Hospital
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University of Liege
investigator full name: Christophe Demoulin
investigator title: Invited Professor
sharing ipd: No