TULIP et MASC : Premiers Usages (TEMPUS)
Primary Purpose
Thoracic Outlet Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
About this trial
This is an interventional other trial for Thoracic Outlet Syndrome focused on measuring suspicion of arterial TOS and/or veinous TOS, DASH questionnaire, TULIP and MASC questionnaires
Eligibility Criteria
Inclusion Criteria:
- Suspicion of Thoracic Outlet Syndrome
Exclusion Criteria:
Non applicable
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with suspicion of TOS
Arm Description
Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
MASC : Concording with DASH questionnaire
Correlation coefficient with the DASH questionnaire
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.
Full Information
NCT ID
NCT05441176
First Posted
June 23, 2022
Last Updated
September 12, 2022
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT05441176
Brief Title
TULIP et MASC : Premiers Usages
Acronym
TEMPUS
Official Title
TULIP et MASC : Premiers Usages
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Two questionnaires the TULIP and the MASC are submitted (self completion) to patients suspected of TOS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Outlet Syndrome
Keywords
suspicion of arterial TOS and/or veinous TOS, DASH questionnaire, TULIP and MASC questionnaires
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with suspicion of TOS
Arm Type
Experimental
Arm Description
Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Scoring of the DASH is performed according to references.
Primary Outcome Measure Information:
Title
Feasibility of both questionnaires : percentage of questionnaires correctly completed
Description
Estimation of the percentage of questionnaires correctly completed. "correctly completed" means a questionnaire without physician's correction.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation
Description
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
Title
MASC : Concording with DASH questionnaire
Description
Correlation coefficient with the DASH questionnaire
Time Frame
1 day
Title
MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH
Description
Comparison of correlation coefficient with the DASH questionnaire and of correlation coefficient with the Quick-DASH questionnaire.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspicion of Thoracic Outlet Syndrome
Exclusion Criteria:
Non applicable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanne HERSANT, PhD
Phone
(0)241353689
Ext
+33
Email
explovasculaire@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marine MAUBOUSSIN
Phone
(0)668047430
Ext
+33
Email
marine.mauboussin@chu-angers.fr
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne HERSANT, PhD
Phone
(0)241353686
Ext
+33
Email
explovasculaire@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Jeanne HERSANT, PhD
12. IPD Sharing Statement
Learn more about this trial
TULIP et MASC : Premiers Usages
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