Thoracic Outlet SyndromeENMG-AFCNCT05360303
Electromyography in Thoracic Outlet Syndrome
An observational study of Thoracic Outlet Syndrome, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Outlet Syndrome
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2022to 23 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Inpatient rehabilitation for thoracic outlet syndrome
- Patients' agreement
Who cannot join
- < 18 years old
- Not able to consent
- Pregnancy
- Musculoskeletal disorders of the upper limbs
- Acute cardiac, pulmonary, metabolic or neurological diseases
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Physical Medicine and Locomotive Rehabilitation (Nantes University Hospital)
Nantes
About this study
Official title: 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.
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Thoracic outlet syndrome, electromyography, neurogenic, rehabilitation, diagnosis
- Medical subject headings
- Thoracic Outlet Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 Month
Secondary outcomes (3)
Evaluation of ENMG changes following rehabilitation treatment of patients
evolution of electrophysiological changes following treatment
Measured: 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)
Measured: 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)
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start9 Nov 2022
- Primary completion23 Feb 2024
- Study completion23 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360303
- Sponsor's protocol ID
- RC22_0229
- Acronym
- ENMG-AFC
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Electroneuromyography in the Diagnosis of Thoracic Outlet Syndrome
- ClinicalTrials.gov ID
- NCT05360303
- Acronym / sponsor ID
- ENMG-AFC / RC22_0229
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Thoracic outlet syndrome, electromyography, neurogenic, rehabilitation, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Mar 2024 (actual)
- First posted
- 4 May 2022 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial population | – | –No Intervention but evaluation of the electroneuromyography at the M1 visit for patients with a clinical diagnostic of thoracic outlet syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Inpatient rehabilitation for thoracic outlet syndrome
- Patients' agreement
Key exclusion criteria (5 listed)
- < 18 years old
- Not able to consent
- Pregnancy
- Musculoskeletal disorders of the upper limbs
- Acute cardiac, pulmonary, metabolic or neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 0 Month
Conduction abnormality of the medial cutaneous nerve of the forearm
3 secondary outcomes
Evaluation of ENMG changes following rehabilitation treatment of patients
Time frame: 1 Month
Evaluation of ENMG changes following rehabilitation treatment of patients
Time frame: 1 Month
Evaluation of ENMG changes following rehabilitation treatment of patients
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Thoracic Outlet Syndrome
Recruiting
Motivational Interviewing in Thoracic Outlet Syndrome
Thoracic Outlet Syndrome
Recruiting
Immediate Effects of Kinesio Taping on Thoracic Outlet Syndrome
Thoracic Outlet Syndrome
Not yet recruiting
Effect of Mechanically Loaded Neuro-dynamics in Subjects With Thoracic Outlet Syndrome
Thoracic Outlet Syndrome, Mechanically Loaded Neuro-dynamics
Not yet recruiting
Effect of Low-Power Laser Therapy on Pain and Functional Outcomes in Patients With Thoracic Outlet Syndrome
Thoracic Outlet Syndrome
RecruitingObservational study
Vascular Lab Resource (VLR) Biorepository
Cardiovascular Diseases, Metabolic Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 Apr 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 0 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2024.