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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03780647
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : August 5, 2019
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
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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 ]

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT03780647

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Contact: André THEVENON, MD,PhD 03 20 44 58 31 ext +33

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Hôpital Swynghedau, CHU Recruiting
Lille, France
Principal Investigator: André THEVENIN, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: André THEVENON, MD,PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille 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: August 5, 2019
Last Verified: August 2019

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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
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases