Clinical Routine in Thoracic Outlet Syndrome

NCT ID: NCT04376177

Last Updated: 2021-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will have recording on a database of all investigations that were eventually performed for the diagnosis or follow up of their disease, among which:

* Characteristics (Age, Gender height, weight, ongoing treatment ,
* professional activity, sports activity,
* Symptoms.
* Forearm and finger photoplethysmography (PPG) during provocative maneuvers of the upper limb
* Transcutaneous oxymetry (Tcpo2) recording
* Standard questionnaires (MASC, DASH, FS36)
* Doppler and ultrasound during provocative maneuvers of the upper limb
* Angiography during provocative maneuvers of the upper limb
* Electromyogram
* Standard X-ray

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Outlet Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Thoracic outlet syndrome

Patients referred to the University Hospital of Angers for the diagnostis or follow-up of thoracic outlet syndrome

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.

angiography

Intervention Type DIAGNOSTIC_TEST

Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.

questionnaires

Intervention Type DIAGNOSTIC_TEST

Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.

Transcutaneous oximetry

Intervention Type DIAGNOSTIC_TEST

Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.

plethysmography

Intervention Type DIAGNOSTIC_TEST

Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis

Electromyogram

Intervention Type DIAGNOSTIC_TEST

Electromyography of the upper limbs with encoding of the physician for the presence or abnsence of signs of plexis compression (impairment of the response on C8 T1 erea

Standard X-Ray

Intervention Type DIAGNOSTIC_TEST

Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound

Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.

Intervention Type DIAGNOSTIC_TEST

angiography

Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.

Intervention Type DIAGNOSTIC_TEST

questionnaires

Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.

Intervention Type DIAGNOSTIC_TEST

Transcutaneous oximetry

Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.

Intervention Type DIAGNOSTIC_TEST

plethysmography

Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis

Intervention Type DIAGNOSTIC_TEST

Electromyogram

Electromyography of the upper limbs with encoding of the physician for the presence or abnsence of signs of plexis compression (impairment of the response on C8 T1 erea

Intervention Type DIAGNOSTIC_TEST

Standard X-Ray

Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Absence of deny for the use of medical filesfor research purposes

Exclusion Criteria

* Inability to understand the purpose of the database.
* Patient protected by law.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pierre ABRAHAM, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University and univerity hospital in Angers, FRANCE

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Angers, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

pierre Abraham, MD PhD

Role: CONTACT

+33241353689

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pierre ABRAHAM, MD PhD

Role: primary

+33241353689

References

Explore related publications, articles, or registry entries linked to this study.

Hersant J, Lecoq S, Ramondou P, Feuilloy M, Abraham P, Henni S. Upper arm versus forearm transcutaneous oximetry during upper limb abduction in patients with suspected thoracic outlet syndrome. Front Physiol. 2022 Nov 8;13:1033137. doi: 10.3389/fphys.2022.1033137. eCollection 2022.

Reference Type DERIVED
PMID: 36425296 (View on PubMed)

Hersant J, Ramondou P, Josse C, Lecoq S, Henni S, Abraham P. Quantitative analysis of venous outflow with photo-plethysmography in patients with suspected thoracic outlet syndrome. Front Cardiovasc Med. 2022 Oct 28;9:803919. doi: 10.3389/fcvm.2022.803919. eCollection 2022.

Reference Type DERIVED
PMID: 36386307 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020/17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TULIP et MASC : Premiers Usages
NCT05441176 COMPLETED NA