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Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work (PROCTB)

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ClinicalTrials.gov Identifier: NCT03780647
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
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

Condition or disease Intervention/treatment
Thoracic Outlet Syndrome Other: questionnaire

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Group/Cohort Intervention/treatment
Patients with suspicion of thoracic outlet syndrome Other: questionnaire
Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis




Primary Outcome Measures :
  1. Frequency of an impairment at work [ Time Frame: Baseline: one session ]

Secondary Outcome Measures :
  1. Frequency of job loss [ Time Frame: Baseline: one session ]
  2. Frequency of income loss [ Time Frame: Baseline: one session ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients sent to the University Hospital radiology department or to an angiologist with private practice for a suspicion of thoracic outlet syndrome, with diagnosis confirmed by Echo-Doppler
Criteria

Inclusion Criteria:

  • A stenosis of at least 80% of arterial stenosis at Echo-Doppler examination during abduction-retropulsion of the arm
  • Actually employed or having been employed

Exclusion Criteria:

  • Cognitive or mental impairment
  • Illiteracy
  • Visual impairment
  • Patients having been diagnosed with fibromyalgia, chronic fatigue syndrome or ehler-Danlos syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780647


Contacts
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Contact: André THEVENON, MD,PhD 03 20 44 58 31 ext +33 andre.thevenon@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: André THEVENON, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03780647     History of Changes
Other Study ID Numbers: 2017_26
2018-A00289-46 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Thoracic outlet syndrome
Performance at work

Additional relevant MeSH terms:
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Syndrome
Thoracic Outlet Syndrome
Disease
Pathologic Processes
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases