NCT05441176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 23, 2022

Last Update Submit

June 10, 2024

Conditions

Keywords

suspicion of arterial TOS and/or veinous TOSDASH questionnaireTULIP and MASC questionnaires

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation

    1 day

  • MASC : Concording with DASH questionnaire

    1 day

  • MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH

    1 day

Study Arms (1)

Patients with suspicion of TOS

EXPERIMENTAL

Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires

Other: Questionnaires

Interventions

Scoring of the DASH is performed according to references.

Patients with suspicion of TOS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspicion of Thoracic Outlet Syndrome

You may not qualify if:

  • Non applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2022

First Posted

July 1, 2022

Study Start

September 12, 2022

Primary Completion

September 18, 2023

Study Completion

September 18, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations