Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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.
 
ClinicalTrials.gov Identifier: NCT03780647
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date December 18, 2018
First Posted Date December 19, 2018
Last Update Posted Date August 5, 2019
Actual Study Start Date December 17, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2018)
Frequency of an impairment at work [ Time Frame: Baseline: one session ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03780647 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 18, 2018)
  • Frequency of job loss [ Time Frame: Baseline: one session ]
  • Frequency of income loss [ Time Frame: Baseline: one session ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work
Official Title Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Thoracic Outlet Syndrome
Intervention Other: questionnaire
Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis
Study Groups/Cohorts Patients with suspicion of thoracic outlet syndrome
Intervention: Other: questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 18, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: André THEVENON, MD,PhD 03 20 44 58 31 ext +33 andre.thevenon@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03780647
Other Study ID Numbers 2017_26
2018-A00289-46 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: André THEVENON, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date August 2019