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

May 11, 2021 updated by: University Hospital, Lille
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Swynghedau, CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of an impairment at work
Time Frame: Baseline: one session
Baseline: one session

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of job loss
Time Frame: Baseline: one session
Baseline: one session
Frequency of income loss
Time Frame: Baseline: one session
Baseline: one session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: André Thevenon, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Actual)

February 16, 2021

Study Completion (Actual)

February 16, 2021

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017_26
  • 2018-A00289-46 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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