<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/NCT03306784</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0182</org_study_id>
    <nct_id>NCT03306784</nct_id>
  </id_info>
  <brief_title>Pain Catastrophizing and Routine Assessment of Patient Index Data 3(RAPID3) in Ten Categories of Rheumatology Outpatients</brief_title>
  <official_title>Transversal Study of Correlations Between Pain Catastrophizing Scale (PCS) and RAPID3 Score According to Ten Categories of Conditions Seen in an Outpatient Rheumatology Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient&#xD;
      rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including&#xD;
      RAPID3 and pain catastrophizing scales.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology&#xD;
      clinic from a university French hospital in at least one month period) of a set of 6&#xD;
      questionnaires including a RAPID3 score (Routine Assessment of Patient Index Data 3) and pain&#xD;
      catastrophizing scale, as well as Pain detect and Hospital Anxiety and Depression scale&#xD;
      questionnaires (HAD) , in ten predefined categories of disorders: rheumatoid arthritis; any&#xD;
      spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of&#xD;
      the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or&#xD;
      radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue&#xD;
      conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and&#xD;
      related conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ranking of PCS scores according to the underlying disorders (10 predefined categories), and also ranking of RAPID-3 scores according to the underlying disorders (10 predefined categories).</measure>
    <time_frame>At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).</time_frame>
    <description>Composite score: RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ranking of correlations between RAPID3 and Pain catastrophizing scale (PCS) (13 items) scores in the 10 subsets of categories listed above (from the strongest correlation to the lowest correlation)</measure>
    <time_frame>At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).</time_frame>
    <description>RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients</description>
  </secondary_outcome>
  <enrollment type="Actual">572</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <condition>Spondyloarthritis</condition>
  <condition>Inflammatory Rheumatisms</condition>
  <condition>Systemic Disorders</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaires</intervention_name>
    <description>questionnaires, including RAPID3 and pain catastrophizing scales</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        300 Men or women coming to the Rheumatology Department of the Nantes University Hospital&#xD;
        with a senior rheumatologist agreeing to fulfil the set of 6 questionnaires&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any outpatient aged 18 or more, agreeing to fulfil the set of 6 questionnaires&#xD;
&#xD;
          -  Man or woman coming to the Rheumatology Department of the Nantes University Hospital&#xD;
             with a senior rheumatologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not fluent enough in French or suffering from neurological or psychological&#xD;
             disorders making their responses unreliable&#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>Jean-Marie Berthelot, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RAPID3</keyword>
  <keyword>pain catastrophizing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Rheumatic Fever</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
    <mesh_term>Rheumatic Diseases</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/NCT03306784
org study id: RC17_0182
nct id: NCT03306784
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient
      rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including
      RAPID3 and pain catastrophizing scales.
Fulfilling by all patients (seen by 6 rheumatologists in a same outpatient rheumatology
      clinic from a university French hospital in at least one month period) of a set of 6
      questionnaires including a RAPID3 score (Routine Assessment of Patient Index Data 3) and pain
      catastrophizing scale, as well as Pain detect and Hospital Anxiety and Depression scale
      questionnaires (HAD) , in ten predefined categories of disorders: rheumatoid arthritis; any
      spondyloarthritis; other inflammatory rheumatisms or systemic disorders; osteoarthritis of
      the upper part of the body; osteoarthritis of the lower part of the body; back pain and/or
      radiculalgia; bone disorders, including osteoporosis; tendinosis and other soft tissue
      conditions; peripheral neuropathy, including entrapment neuropathies; fibromyalgia and
      related conditions.
observational model: Other
time perspective: Prospective
measure: Ranking of PCS scores according to the underlying disorders (10 predefined categories), and also ranking of RAPID-3 scores according to the underlying disorders (10 predefined categories).
time frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
description: Composite score: RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients.
measure: Ranking of correlations between RAPID3 and Pain catastrophizing scale (PCS) (13 items) scores in the 10 subsets of categories listed above (from the strongest correlation to the lowest correlation)
time frame: At least one month for each physician, and at least 30 patients in each category (whatever the physician seen).
description: RAPID3 (0-30) and PCS (0-52) are widely used scales, suitable for routine fulfillment by outpatients
intervention type: Other
intervention name: questionnaires
description: questionnaires, including RAPID3 and pain catastrophizing scales
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marie Berthelot, Dr
role: Principal Investigator
affiliation: CHU de Nantes
facility: 
country: France
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Rheumatic Fever
mesh term: Spondylarthritis
mesh term: Arthritis, Rheumatoid
mesh term: Rheumatic Diseases