CFD Analysis and Risk of TOS in Sport (COFLUTOSPO)

June 10, 2020 updated by: Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

Computational Fluid Dynamics Analysis for the Risk of Thoracic Outlet Syndrome in Sporty Subjects

Thoracic outlet syndrome (TOS) may complicate the activities of sporty subjects that participate in sports that involves upper extremities activities, such as baseball, tennis, swimming, rowing, volleyball, rugby football, and weightlifting. Disability and postintervention recovery related to TOS treatment and possible surgery may have a significant impact in the overall performance abilities of athletes. This study aims to detect the early predisposition of athletes to TOS onset, by means of computational fluid dynamics (CFD) analysis of thoracic outlet region.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Repetitive upper extremity use in athletes may be associated with the development of neurogenic and vascular thoracic outlet syndrome (TOS) which typically presents as upper extremity symptoms caused by compression of the neurovascular structures in the area of the neck above the first rib. Clinical manifestations can include upper extremity pain, paresthesias, numbness, weakness, fatigability, swelling, discoloration, and Raynaud phenomenon. Vascular TOS can involve the subclavian artery or vein.

Most patients who suffer TOSs have an anatomical predisposition and sport activities of upper limbs may contribute to TOS onset. Disability and postintervention recovery related to TOS treatment and possible surgery can have a significant effect in the overall performance abilities of affected patients, and little has been published specifically about the risk of TOS athletes. Computational fluid dynamics (CFD) analysis is one of the key analysis methods used in bioengineering applications in studying the cardiovascular system. In this context a typical fluid dynamics analysis involves evaluation of basic fluid properties like flow velocity, and pressure, in relation to time and space.

This study aims to study CFD factors in thoracic outlet region (cervicothoracobrachial region) in order to evaluate the fluid - structure interactions between muscles, bones and vessels in this region in sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting.

A cohort of healthy sporty subjects will be recruited and will undergo to diagnostic tests in order to assess the thoracic outlet region. For this reason, a Magnetic Resonance scan of the cervicothoracobrachial region and a duplex ultrasound of the upper limbs will be performed.

COMSOL Multiphysics ® cross-platform will be used for elements analysis, in the simulation study. The simulation will be implemented with FreeCAD 3d modeling in order to 3D geometry of studied elements.

The primary endpoint of this study is to calculate the risk of TOS onset in sporty subjects in order to prevent a disabling disease in this kind of subjects.

Study Type

Observational

Enrollment (Anticipated)

100

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

  • Italy
      • Catanzaro, Italy, 88100
        • Recruiting
        • University Magna Graecia of Catanzaro

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population is represented of healthy sporty and non-sporty people that have no symptoms of thoracic outlet syndrome at the moment of observation.

Description

Inclusion Criteria:

For "Sporty" Group:

sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting

For "Non-Sporty" Group:

Subject not involved in sport activities

For both groups:

Exclusion Criteria:

  • presence of muscular or bone problems,
  • presence of peripheral arterial disease,
  • presence of malignant tumors,
  • presence of serious cardiovascular and cerebrovascular pathologies,
  • presence of renal and hepatic insufficiency
  • subjects diagnosed with thoracic outlet syndrome or with symptoms related to the aforementioned syndrome.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy sporty subjects
Healthy sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting.
Diagnostic test: Magnetic Resonance Scan of Thoracic outlet region
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
Diagnostic test: Duplex Ultrasound assessment of Upper limbs
Both groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs.
Healthy non-sporty subjects
Healthy subjects that do not partecipate in sport activities.
Diagnostic test: Magnetic Resonance Scan of Thoracic outlet region
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
Diagnostic test: Duplex Ultrasound assessment of Upper limbs
Both groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluid-structure interaction analysis
Time Frame: at 9 month
Fluid-structure interaction of the thoracic outlet will be analyzed between sport and non-sporty subjects, in order to calculate the risk of Thoracic outlet syndrome onset.
at 9 month

Collaborators and Investigators

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

Sponsor

University of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ER.ALL.2018.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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