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Completed

NCT Number: NCT05441176

TULIP et MASC : Premiers Usages

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.

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Key information

Conditions

Thoracic Outlet Syndrome Cardiovascular Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Angers, 49933, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspicion of Thoracic Outlet Syndrome

Exclusion criteria

Non applicable

Treatment and study plan

questionnaires

Other

Scoring of the DASH is performed according to references.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. MASC : Concording with DASH questionnaire

    Time frame: 1 day

    Correlation coefficient with the DASH questionnaire

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: TEMPUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2022
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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