TULIP et MASC : Premiers Usages (TEMPUS)

June 10, 2024 updated by: University Hospital, Angers

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

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Suspicion of Thoracic Outlet Syndrome

Exclusion Criteria:

Non applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

September 18, 2023

Study Completion (Actual)

September 18, 2023

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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