Thoracic Outlet SyndromeCOFLUTOSPONCT04428125
CFD Analysis and Risk of TOS in Sport
An observational study of Thoracic Outlet Syndrome and Sport Injury, run by University of Catanzaro at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Outlet Syndrome, Sport Injury
- What is being tested?
- Magnetic Resonance Scan of Thoracic outlet region and Duplex Ultrasound assessment of Upper limbs
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 1 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Magna Graecia of Catanzaro
Catanzaro, 88100
Raffaele Serra, M.D., Ph.D., +3909613647380, rserra@unicz.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracic Outlet Syndrome, Sport Injury
- Being tested
- Magnetic Resonance Scan of Thoracic outlet region, Duplex Ultrasound assessment of Upper limbs
- Keywords
- Thoracic Outlet Syndrome, Sports, Computational fluid dynamics
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Scan of Thoracic outlet regionDiagnostic test
Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
Duplex Ultrasound assessment of Upper limbsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy sporty subjects | Healthy sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting. Receives: Diagnostic Test: Magnetic Resonance Scan of Thoracic outlet region; Diagnostic Test: Duplex Ultrasound assessment of Upper limbs | |
| Healthy non-sporty subjects | Healthy subjects that do not partecipate in sport activities. Receives: Diagnostic Test: Magnetic Resonance Scan of Thoracic outlet region; Diagnostic Test: Duplex Ultrasound assessment of Upper limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Mar 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, M.D., Ph.D., Principal investigator, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428125
- Sponsor's protocol ID
- ER.ALL.2018.17
- Acronym
- COFLUTOSPO
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24835692Duwayri 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.
PubMed 21276687Melby 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.
PubMed 18280096Epidemiology, diagnosis and treatment of thoracic outlet syndrome: A systematic review. Acta Phlebol. 2015;16(2):59-68.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Fluid Dynamics Analysis for the Risk of Thoracic Outlet Syndrome in Sporty Subjects
- ClinicalTrials.gov ID
- NCT04428125
- Acronym / sponsor ID
- COFLUTOSPO / ER.ALL.2018.17
- Conditions
- Thoracic Outlet Syndrome, Sport Injury
- Keywords
- Thoracic Outlet Syndrome, Sports, Computational fluid dynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy sporty subjects | – | Diagnostic Test: Magnetic Resonance Scan of Thoracic outlet region, Diagnostic Test: Duplex Ultrasound assessment of Upper limbsHealthy sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting. |
| Healthy non-sporty subjects | – | Diagnostic Test: Magnetic Resonance Scan of Thoracic outlet region, Diagnostic Test: Duplex Ultrasound assessment of Upper limbsHealthy subjects that do not partecipate in sport activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- sporty subjects that participate in the following sports: baseball, tennis, swimming, rowing, volleyball, rugby football, weightlifting
- Subject not involved in sport activities
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Scan of Thoracic outlet regionBoth groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region. | Diagnostic test | Healthy non-sporty subjects, Healthy sporty subjects |
| Duplex Ultrasound assessment of Upper limbsBoth groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs. | Diagnostic test | Healthy non-sporty subjects, Healthy sporty subjects |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Background: PubMed 24835692Chandra 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.
- Background: PubMed 21276687Duwayri 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.
- Background: PubMed 18280096Melby 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.
- BackgroundEpidemiology, diagnosis and treatment of thoracic outlet syndrome: A systematic review. Acta Phlebol. 2015;16(2):59-68.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Serra, M.D., Ph.D. principal investigator
University Magna Graecia of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Outlet Syndrome and Sport Injury, run by University of Catanzaro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Serra, M.D., Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid-structure interaction analysis (time frame: at 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428125, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.