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NCT05441176 Clinical Trial

TULIP et MASC : Premiers Usages

Thoracic Outlet Syndrome Clinical Trial

— TEMPUS  

Official title:
TULIP et MASC : Premiers Usages

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05441176
Other study ID # 2022-A01451-42
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2022
Est. completion date September 18, 2023

Study information
Verified date June 2024
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 18, 2023
Est. primary completion date September 18, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Suspicion of Thoracic Outlet Syndrome Exclusion Criteria: Non applicable

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaires
Scoring of the DASH is performed according to references.

Locations
Country Name City State
France University Hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 day
Secondary 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)		 1 day
Secondary MASC : Concording with DASH questionnaire Correlation coefficient with the DASH questionnaire 1 day
Secondary 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. 1 day
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