Clinical Routine in Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

— SKIPA  

Official title:

Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376177
• Other study ID #: 2020/17
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 2025

Study information

• Verified date: June 2021
• Source: University Hospital, Angers
• Contact: pierre Abraham, MD PhD
• Phone: +33241353689
• Email: piabraham[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

Diagnostic Test:
• Ultrasound
Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.
• angiography
Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.
• questionnaires
Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.
• Transcutaneous oximetry
Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.
• plethysmography
Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis
• 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
• Standard X-Ray
Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	angiography encoding	Retrieval of angiography interpretation as recorded in the patients' file by the physician that performed the test	1 week
Other	Questionnaire scoring	Scoring of the questionnaires according to their respective scoring methods	1 hour
Other	Transcutaneous oximetry	Recording of the decrease from rest of oxygen pressure (DROP) minimal value observed during the provocative maneuvers	1 hour
Other	Plethysmography interpretation	Analysis of the pattern of volume changes observed during provocative maneuvers	1 hour
Primary	ultrasound	Retrieval of ultrasound interpretation as recorded in the patients' file by the physician that performed the test	1 hour