An observational study in Thoracic Outlet Syndrome and Sport Injury, sponsored by University of Catanzaro. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by University of Catanzaro · Observational
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.
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.
33 studies on the registry are indexed under Thoracic Outlet Syndrome; 12 are open to participants now.
This study's planned enrollment of 100 is above the median of 84 across 16 observational studies indexed under Thoracic Outlet Syndrome.
Browse Thoracic Outlet Syndrome studies →University of Catanzaro is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
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The population is represented of healthy sporty and non-sporty people that have no symptoms of thoracic outlet syndrome at the moment of observation.
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:
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 · Diagnostic Test: Duplex Ultrasound assessment of Upper limbs
Healthy subjects that do not partecipate in sport activities.
Diagnostic Test: Magnetic Resonance Scan of Thoracic outlet region · Diagnostic Test: Duplex Ultrasound assessment of Upper limbs
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
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.
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.
Time frame: at 9 month
Plan to share: No
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Catanzaro