Electromyography in Thoracic Outlet Syndrome (ENMG-AFC)

Interest of Electroneuromyography in the Diagnosis of Thoracic Outlet Syndrome

Record the ENMG data carried out systematically in patients treated by rehabilitation for thoracic outlet syndrome in order to assess their characteristics and judge the relevance of these data in the context of the diagnosis and their possible modifications following the rehabilitation treatment.

Study Overview

• Status: Completed
• Conditions: Thoracic Outlet Syndrome

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a thoracic outlet syndrome who will be included during their usual rehabilitation management. They will benefit from the usual Electromyography of stimulodetection with surface electrodes at the beginning of the management. The same examination will be performed at the end of the treatment to evaluate the impact of the rehabilitation on the electrophysiological results and to orientate, if necessary, towards a potential surgery.

Description

Inclusion Criteria:

• Inpatient rehabilitation for thoracic outlet syndrome
• Patients' agreement

Exclusion Criteria:

• < 18 years old
• Not able to consent
• Pregnancy
• Musculoskeletal disorders of the upper limbs
• Acute cardiac, pulmonary, metabolic or neurological diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Trial population; No Intervention but evaluation of the electroneuromyography at the M1 visit for patients with a clinical diagnostic of thoracic outlet syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the presence of ENMG abnormality and in particular on the medial cutaneous nerve of the forearm of patients with a clinical diagnosis of TOS	Conduction abnormality of the medial cutaneous nerve of the forearm	0 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of ENMG changes following rehabilitation treatment of patients	evolution of electrophysiological changes following treatment	1 Month
Evaluation of ENMG changes following rehabilitation treatment of patients	evolution of the Visual Analog Score for pain (scale from 0 to 10 ; 10 being the worst outcome)	1 Month
Evaluation of ENMG changes following rehabilitation treatment of patients	evolution of the Quick Disabilities of the Arm, Shoulder and Hand Score (scale from 0 to 100 ; 100 being the worst outcome)	1 Month

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): March 23, 2024

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; diagnosis; electromyography; neurogenic; Thoracic outlet syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome
• Other Study ID Numbers: RC22_0229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No