Assessment of the Impact of Thoracic Outlet Syndromes on... | NCT03780647

Studies
Assessment of the Impact of Thoracic Outlet Syndromes on the Performance at Work

NCT03780647

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Apr 21, 2026Actual

Enrollment

101Actual

Phase

Not provided

Conditions

Thoracic Outlet Syndrome

Interventions

questionnaire

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A00289-46	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2018Actual

Primary Completion Date

Feb 16, 2021Actual

Completion Date

Feb 16, 2021Actual

First Submitted Date

Dec 18, 2018

First Submission Date that Met QC Criteria

Dec 18, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 21, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with suspicion of thoracic outlet syndrome			Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis	Patients with suspicion of thoracic outlet syndrome

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
André THEVENON, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Swynghedau, CHU		Lille			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37697402	Result	Logiou C, Demondion X, Tiffreau V, Wieczorek V, Thevenon A. Evaluation of the socioprofessional consequences of thoracic outlet syndrome. BMC Res Notes. 2023 Sep 11;16(1):207. doi: 10.1186/s13104-023-06448-2.

ID	Term
D009408	Nerve Compression Syndromes
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms