<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/NCT03780647</url>
  </required_header>
  <id_info>
    <org_study_id>2017_26</org_study_id>
    <secondary_id>2018-A00289-46</secondary_id>
    <nct_id>NCT03780647</nct_id>
  </id_info>
  <brief_title>Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work</brief_title>
  <acronym>PROCTB</acronym>
  <official_title>Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The&#xD;
      responsibility of repetitive movements and postural factors has been mentioned for long. Some&#xD;
      tasks are hard to perform, and it seemed interesting to assess the consequences of this&#xD;
      syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    due to Covid19 pandemic , the inclusions slow down , and the rate of occupational problems&#xD;
    exceeding by more than 300% changing the objective and the size of the study&#xD;
  </why_stopped>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">February 16, 2021</completion_date>
  <primary_completion_date type="Actual">February 16, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of an impairment at work</measure>
    <time_frame>Baseline: one session</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of job loss</measure>
    <time_frame>Baseline: one session</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of income loss</measure>
    <time_frame>Baseline: one session</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Thoracic Outlet Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients with suspicion of thoracic outlet syndrome</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis</description>
    <arm_group_label>Patients with suspicion of thoracic outlet syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients sent to the University Hospital radiology department or to an angiologist with&#xD;
        private practice for a suspicion of thoracic outlet syndrome, with diagnosis confirmed by&#xD;
        Echo-Doppler&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A stenosis of at least 80% of arterial stenosis at Echo-Doppler examination during&#xD;
             abduction-retropulsion of the arm&#xD;
&#xD;
          -  Actually employed or having been employed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive or mental impairment&#xD;
&#xD;
          -  Illiteracy&#xD;
&#xD;
          -  Visual impairment&#xD;
&#xD;
          -  Patients having been diagnosed with fibromyalgia, chronic fatigue syndrome or&#xD;
             ehler-Danlos syndrome&#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>André THEVENON, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Swynghedau, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thoracic outlet syndrome</keyword>
  <keyword>Performance at work</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Outlet Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03780647
org study id: 2017_26
secondary id: 2018-A00289-46
nct id: NCT03780647
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thoracic outlet syndrome may associate neurologic, arterial and venous symptoms. The
      responsibility of repetitive movements and postural factors has been mentioned for long. Some
      tasks are hard to perform, and it seemed interesting to assess the consequences of this
      syndrome on the work capacity by a questionnaire, at the moment of diagnosis by Echo-Doppler
observational model: Cohort
time perspective: Cross-Sectional
measure: Frequency of an impairment at work
time frame: Baseline: one session
measure: Frequency of job loss
time frame: Baseline: one session
measure: Frequency of income loss
time frame: Baseline: one session
arm group label: Patients with suspicion of thoracic outlet syndrome
intervention type: Other
intervention name: questionnaire
description: Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis
arm group label: Patients with suspicion of thoracic outlet syndrome
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: André THEVENON, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Thoracic Outlet Syndrome
mesh term: Syndrome