TULIP et MASC : Premiers Usages (TEMPUS)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Angers, France, 49933
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Suspicion of Thoracic Outlet Syndrome
Exclusion Criteria:
Non applicable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with suspicion of TOS
Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires
|
Scoring of the DASH is performed according to references.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of both questionnaires : percentage of questionnaires correctly completed
Time Frame: 1 day
|
Estimation of the percentage of questionnaires correctly completed.
"correctly completed" means a questionnaire without physician's correction.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation
Time Frame: 1 day
|
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) |
1 day
|
|
MASC : Concording with DASH questionnaire
Time Frame: 1 day
|
Correlation coefficient with the DASH questionnaire
|
1 day
|
|
MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH
Time Frame: 1 day
|
Comparison of correlation coefficient with the DASH questionnaire and of correlation coefficient with the Quick-DASH questionnaire.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A01451-42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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