NCT05360303

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 9, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

April 25, 2022

Last Update Submit

April 16, 2024

Conditions

Keywords

Thoracic outlet syndromeelectromyographyneurogenicrehabilitationdiagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluation of ENMG changes following rehabilitation treatment of patients

    1 Month

  • Evaluation of ENMG changes following rehabilitation treatment of patients

    1 Month

  • Evaluation of ENMG changes following rehabilitation treatment of patients

    1 Month

Study Arms (1)

Trial population

No Intervention but evaluation of the electroneuromyography at the M1 visit for patients with a clinical diagnostic of thoracic outlet syndrome.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Inpatient rehabilitation for thoracic outlet syndrome
  • Patients' agreement

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nantes, France

Location

MeSH Terms

Conditions

Thoracic Outlet SyndromeDisease

Condition Hierarchy (Ancestors)

Nerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 4, 2022

Study Start

November 9, 2022

Primary Completion

February 23, 2024

Study Completion

March 23, 2024

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations