CFD Analysis and Risk of TOS in Sport

Sport Injury Clinical Trial

— COFLUTOSPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428125
• Other study ID #: ER.ALL.2018.17
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: June 2020
• Source: University of Catanzaro
• Contact: Raffaele Serra, M.D., Ph.D.
• Phone: +3909613647380
• Email: rserra[@]unicz.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Injuries
• Sport Injury
• Syndrome
• Thoracic Outlet Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	University Magna Graecia of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Chandra V, Little C, Lee JT. Thoracic outlet syndrome in high-performance athletes. J Vasc Surg. 2014 Oct;60(4):1012-7; discussion 1017-8. doi: 10.1016/j.jvs.2014.04.013. Epub 2014 May 14. — View Citation

Duwayri YM, Emery VB, Driskill MR, Earley JA, Wright RW, Paletta GA Jr, Thompson RW. Positional compression of the axillary artery causing upper extremity thrombosis and embolism in the elite overhead throwing athlete. J Vasc Surg. 2011 May;53(5):1329-40. doi: 10.1016/j.jvs.2010.11.031. Epub 2011 Jan 26. — View Citation

Epidemiology, diagnosis and treatment of thoracic outlet syndrome: A systematic review. Acta Phlebol. 2015;16(2):59-68.

Melby SJ, Vedantham S, Narra VR, Paletta GA Jr, Khoo-Summers L, Driskill M, Thompson RW. Comprehensive surgical management of the competitive athlete with effort thrombosis of the subclavian vein (Paget-Schroetter syndrome). J Vasc Surg. 2008 Apr;47(4):809-820; discussion 821. doi: 10.1016/j.jvs.2007.10.057. Epub 2008 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid-structure interaction analysis	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