<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/NCT03277885</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-347</org_study_id>
    <nct_id>NCT03277885</nct_id>
  </id_info>
  <brief_title>Prevalence of Pain Disorders in Employees of French Furniture Shop.</brief_title>
  <acronym>PREVADouleur</acronym>
  <official_title>Evaluation of the Prevalence of Pain Disorders in a Professional Context Among Employees of French Furniture Shop.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In France, the Direction of Research, Studies, Evaluation and Statistics, in their 2015&#xD;
      report on &quot;Chronic pain: the state of health of the population in France - Indicators&#xD;
      associated with the Public health &quot;, shows that 34.6% of the working population declare&#xD;
      themselves to be facing psycho-social risks, including chronic pain disorders.&#xD;
&#xD;
      The main survey conducted in France on chronic pain showed that 32% of French people&#xD;
      expressed daily pain for more than 3 months, with 20% reporting chronic pain of moderate or&#xD;
      severe intensity. According to a report by the HAS in 2009, about 30% of patients consulting&#xD;
      for pain in pain center (CETD) are working and 20% are on sick leave or work-related&#xD;
      accidents.&#xD;
&#xD;
      Chronic pain would also be responsible in France for the limitation of professional&#xD;
      activities in 6% of 25-64 year olds, 15% job losses, 12% changes in work responsibilities,&#xD;
      12% changes in employment and 18 % of associated depressions. In addition, 40% of chronic&#xD;
      pain patients experienced a direct impact at work: loss, change in responsibilities and&#xD;
      activity.&#xD;
&#xD;
      Combined with the difficulty of understanding and thus treating chronic pain, these data&#xD;
      demonstrate the challenge faced by occupational health services in their preventive, curative&#xD;
      and palliative approach to chronic pathologies. Innovation for any new prevention and therapy&#xD;
      for chronic pain then becomes necessary.&#xD;
&#xD;
      The main objective of this first study will be the evaluation of the prevalence of pain&#xD;
      disorders among the employees of French furniture shop. .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to have the earliest possible representativeness of French furniture shop, a&#xD;
      &quot;virtual&quot; store will be created from 400 volunteer employees from 14 French furniture shop.&#xD;
      Each job will be represented and the number of employees per job will respect the average&#xD;
      proportion observed in the French furniture shop.&#xD;
&#xD;
      Following the on-site presentation of the details of the survey, by a doctor from&#xD;
      Clermont-Ferrand University Hospital, volunteers will be informed within their company of the&#xD;
      start of the survey. Each volunteer employee will have access to the information document&#xD;
      (paper format) explaining in detail the purpose, content and conduct of the survey. If the&#xD;
      voluntary collaborator agrees to participate, he / she will be asked to respond to the survey&#xD;
      via the computer platform of the Clermont-Ferrand University Hospital.&#xD;
&#xD;
      Before completing the questionnaires, the employee will be asked to participate in the&#xD;
      survey, via a YES / NO choice on the computer platform, which will serve as proof of&#xD;
      non-opposition. The employee will be free to reverse his initial decision at any time by&#xD;
      informing the coordinating center.&#xD;
&#xD;
      Volunteers who have agreed to participate in the study will be asked to respond to the survey&#xD;
      questionnaires during each survey. Volunteers will have no obligation to participate in all&#xD;
      investigations.&#xD;
&#xD;
      The data manager of the coordinating center will build a specific and secure platform via the&#xD;
      REDCap website (http://project-redcap.org/). Volunteer collaborators will be provided with&#xD;
      the web link to respond to the survey directly on the REDCap platform at their workplace or&#xD;
      at home.&#xD;
&#xD;
      The deployment of the survey to employees will be carried out over a period of 1 month.&#xD;
&#xD;
      This survey will take place in 4 separate campaigns with a 4-month interval: October /&#xD;
      February / June / October (to give an overview of the season effect on the data, as well as a&#xD;
      longitudinal aspect). During each campaign, employees will be notified and can participate in&#xD;
      the survey. Each employee may participate in one or more investigations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of painful disorders</measure>
    <time_frame>At the end of each survey campaign (a campaign lasts 1 month and is repeated every 4 months for 12 months, a total of 4 campaigns).</time_frame>
    <description>An employee will be considered painful if the pain intensity is greater than 3/10 on a numerical rating scale (0 = no pain at 10 = worst possible pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociodemographic characterization</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of medical and paramedical visits over the past 12 months for a cause of pain.</measure>
    <time_frame>during each survey campaign (4 campaigns over a 12-month period).</time_frame>
    <description>Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression Score</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catastrophism</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire PCS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of pain</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire BPI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of kinesiophobia</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire TSK</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening for neuropathic pain</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire DN4 interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterization of lumbar pain.</measure>
    <time_frame>at day 1</time_frame>
    <description>Questionnaire FABQ</description>
  </secondary_outcome>
  <enrollment type="Actual">400</enrollment>
  <condition>Chronic Pain</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>chronic pain</intervention_name>
    <description>work related chronic pain</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        employees of French furniture shop&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All voluntary employees of French furniture shop&#xD;
&#xD;
          -  Non-opposition to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Employees unable to understand or answer questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian DUALE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Work related chronic pain</keyword>
  <keyword>Preventive care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Somatoform Disorders</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/NCT03277885
org study id: CHU-347
nct id: NCT03277885
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In France, the Direction of Research, Studies, Evaluation and Statistics, in their 2015
      report on "Chronic pain: the state of health of the population in France - Indicators
      associated with the Public health ", shows that 34.6% of the working population declare
      themselves to be facing psycho-social risks, including chronic pain disorders.

      The main survey conducted in France on chronic pain showed that 32% of French people
      expressed daily pain for more than 3 months, with 20% reporting chronic pain of moderate or
      severe intensity. According to a report by the HAS in 2009, about 30% of patients consulting
      for pain in pain center (CETD) are working and 20% are on sick leave or work-related
      accidents.

      Chronic pain would also be responsible in France for the limitation of professional
      activities in 6% of 25-64 year olds, 15% job losses, 12% changes in work responsibilities,
      12% changes in employment and 18 % of associated depressions. In addition, 40% of chronic
      pain patients experienced a direct impact at work: loss, change in responsibilities and
      activity.

      Combined with the difficulty of understanding and thus treating chronic pain, these data
      demonstrate the challenge faced by occupational health services in their preventive, curative
      and palliative approach to chronic pathologies. Innovation for any new prevention and therapy
      for chronic pain then becomes necessary.

      The main objective of this first study will be the evaluation of the prevalence of pain
      disorders among the employees of French furniture shop. .
In order to have the earliest possible representativeness of French furniture shop, a
      "virtual" store will be created from 400 volunteer employees from 14 French furniture shop.
      Each job will be represented and the number of employees per job will respect the average
      proportion observed in the French furniture shop.

      Following the on-site presentation of the details of the survey, by a doctor from
      Clermont-Ferrand University Hospital, volunteers will be informed within their company of the
      start of the survey. Each volunteer employee will have access to the information document
      (paper format) explaining in detail the purpose, content and conduct of the survey. If the
      voluntary collaborator agrees to participate, he / she will be asked to respond to the survey
      via the computer platform of the Clermont-Ferrand University Hospital.

      Before completing the questionnaires, the employee will be asked to participate in the
      survey, via a YES / NO choice on the computer platform, which will serve as proof of
      non-opposition. The employee will be free to reverse his initial decision at any time by
      informing the coordinating center.

      Volunteers who have agreed to participate in the study will be asked to respond to the survey
      questionnaires during each survey. Volunteers will have no obligation to participate in all
      investigations.

      The data manager of the coordinating center will build a specific and secure platform via the
      REDCap website (http://project-redcap.org/). Volunteer collaborators will be provided with
      the web link to respond to the survey directly on the REDCap platform at their workplace or
      at home.

      The deployment of the survey to employees will be carried out over a period of 1 month.

      This survey will take place in 4 separate campaigns with a 4-month interval: October /
      February / June / October (to give an overview of the season effect on the data, as well as a
      longitudinal aspect). During each campaign, employees will be notified and can participate in
      the survey. Each employee may participate in one or more investigations.
observational model: Cohort
time perspective: Retrospective
measure: Prevalence of painful disorders
time frame: At the end of each survey campaign (a campaign lasts 1 month and is repeated every 4 months for 12 months, a total of 4 campaigns).
description: An employee will be considered painful if the pain intensity is greater than 3/10 on a numerical rating scale (0 = no pain at 10 = worst possible pain).
measure: Sociodemographic characterization
time frame: at day 1
description: Questionnaires
measure: Number of medical and paramedical visits over the past 12 months for a cause of pain.
time frame: during each survey campaign (4 campaigns over a 12-month period).
description: Questionnaires
measure: Anxiety and Depression Score
time frame: at day 1
description: Questionnaire HADS
measure: Quality of life
time frame: at day 1
description: Questionnaire SF-12
measure: Catastrophism
time frame: at day 1
description: Questionnaire PCS
measure: Characterization of pain
time frame: at day 1
description: Questionnaire BPI
measure: Characterization of kinesiophobia
time frame: at day 1
description: Questionnaire TSK
measure: Screening for neuropathic pain
time frame: at day 1
description: Questionnaire DN4 interview
measure: Characterization of lumbar pain.
time frame: at day 1
description: Questionnaire FABQ
intervention type: Other
intervention name: chronic pain
description: work related chronic pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian DUALE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Somatoform Disorders