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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780647
Recruitment Status : Terminated (due to Covid19 pandemic , the inclusions slow down , and the rate of occupational problems exceeding by more than 300% changing the objective and the size of the study)
First Posted : December 19, 2018
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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

Study Design
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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : February 16, 2021
Actual Study Completion Date : February 16, 2021

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Groups and Cohorts
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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France
Hôpital Swynghedau, CHU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: André THEVENON, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03780647    
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: May 12, 2021
Last Verified: May 2021

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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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Thoracic Outlet Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases