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CompletedNCT05441176TEMPUSUpdated Jun 11, 2024

TULIP et MASC : Premiers Usages

An interventional study of Questionnaires in Thoracic Outlet Syndrome, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up.

The TULIP questionnaire aims to characterize the symptoms suggestive of Thoracic Outlet Syndrome (TOS). The MASC questionnaire aims to assess the functional maintenance of TOS in a simpler way (fewer questions) than the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and in a lateralized way.

Read the detailed description

Two questionnaires the TULIP and the MASC are submitted (self completion) to patients suspected of TOS.

02

Conditions studied

  • Thoracic Outlet Syndrome

Keywords

  • suspicion of arterial TOS and/or veinous TOS
  • DASH questionnaire
  • TULIP and MASC questionnaires
03

In context

Thoracic Outlet Syndrome

33 studies on the registry are indexed under Thoracic Outlet Syndrome; 12 are open to participants now.

This study's enrollment of 200 is above the median of 50 across 17 interventional studies indexed under Thoracic Outlet Syndrome.

Browse Thoracic Outlet Syndrome studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Suspicion of Thoracic Outlet Syndrome

Exclusion criteria

Exclusion Criteria:

Non applicable

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Patients with suspicion of TOS

    Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires

    Other: Questionnaires

Interventions

  • OtherQuestionnaires

    Scoring of the DASH is performed according to references.

06

What researchers measure

Primary outcomes

  1. Feasibility of both questionnaires : percentage of questionnaires correctly completed

    Estimation of the percentage of questionnaires correctly completed. "correctly completed" means a questionnaire without physician's correction.

    Time frame: 1 day

Secondary outcomes

  1. TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation

    Determine the diagnostic performance of each response according to the presence or absence of vascular compression of the arm considered. We evaluate the correlation between each response of TULIP's items and vascular investigation results (positive ultrasound or/and angiography)

    Time frame: 1 day

  2. MASC : Concording with DASH questionnaire

    Correlation coefficient with the DASH questionnaire

    Time frame: 1 day

  3. MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH

    Comparison of correlation coefficient with the DASH questionnaire and of correlation coefficient with the Quick-DASH questionnaire.

    Time frame: 1 day

07

Study locations

1 site
  • University Hospital
    Angers, 49933, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05441176
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jul 1, 2022
Start date
Sep 12, 2022
Primary completion
Sep 18, 2023
Completion
Sep 18, 2023
Last update
Jun 11, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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