CFD Analysis and Risk of TOS in Sport

• Conditions: Thoracic Outlet Syndrome; Sport Injury
• Interventions: Diagnostic Test: Magnetic Resonance Scan of Thoracic outlet region; Diagnostic Test: Duplex Ultrasound assessment of Upper limbs

• Registration Number: NCT04428125
• Lead Sponsor: University of Catanzaro

Brief Summary

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.

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 Timeline

• Study Start: 2020-03-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy sporty subjects	Magnetic Resonance Scan of Thoracic outlet region	Healthy sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting.
Healthy non-sporty subjects	Duplex Ultrasound assessment of Upper limbs	Healthy subjects that do not partecipate in sport activities.
Healthy sporty subjects	Duplex Ultrasound assessment of Upper limbs	Healthy sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting.
Healthy non-sporty subjects	Magnetic Resonance Scan of Thoracic outlet region	Healthy subjects that do not partecipate in sport activities.

Primary Outcome Measures

Name	Time	Method
Fluid-structure interaction analysis	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.

Trial Locations

Locations (1)

University Magna Graecia of Catanzaro; 🇮🇹 Catanzaro, Italy