Carpal Tunnel SyndromeNCT05989373
Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.
A study testing Scratch collapse test in people with Carpal Tunnel Syndrome and Ulnar Nerve Compression, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common pathologies, which are treated surgically. Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of typical symptoms and an evocative clinical examination. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Ulnar Nerve Compression
- What is being tested?
- Scratch collapse test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2023to 1 May 2024
- Phase
- Interventional
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated or entitled to a social security plan
- Patient who has received informed information about the study
- Patient of legal age
- Patient with ulnar nerve or carpal tunnel compression confirmed by EMG during preoperative consultation
Who cannot join
- Recurrence of nerve compression
- Any history that may affect arm sensitivity
- Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scratch Collapse Test: Prospective, Objective, Multi Multicenter
Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common pathologies, which are treated surgically.
Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of typical symptoms and an evocative clinical examination. Provocative tests performed in consultation include the Tinel and Phalen sign for the carpal tunnel, and the Tinel and prolonged flexion sign for the ulnar nerve at the elbow.
Read more
The Scratch Collapse Test (SCT) has recently emerged as a new provocation test to help diagnose nerve compression in the upper limb.
This non-invasive, pain-free test looks for a reduction in the force of external rotation of the shoulder by applying resistance (the doctor's arm), before and then after a sensory stimulus by "scratching" the area of compression. Nevertheless, this test remains controversial and not based on objective measurements.
Our aim is therefore to assess shoulder external rotation force, and thus TBS, objectively with a dynamometer, before and after stimulation in cases of median nerve compression syndrome at the carpal tunnel and ulnar nerve compression syndrome at the elbow, when these are clinically and electromyographically proven.
This test has already been studied in the literature, but the results in terms of sensitivity and specificity are highly disparate. One study has already published negative results on the subject, with the limitation that the trial was monocentric.
Through this multicenter study, principal investigator wish to highlight the very probable subjectivity of the SCT when it is performed. As the resistance is applied by the physician's arm, the investigator cannot determine the force applied against the patient, unlike with a measurement object. The principal investigator expects this study to refute the notion that external shoulder rotation force decreases after trigger zone stimulation in cases of proven nerve compression syndrome.
The results of this study will thus make it possible to discontinue the use of this technique if it does not help in the diagnosis of compression.
The literature shows a lack of prospective, objective studies involving a large number of patients.
- Conditions
- Carpal Tunnel Syndrome, Ulnar Nerve Compression
- Being tested
- Scratch collapse test
- Medical subject headings
- Carpal Tunnel Syndrome, Ulnar Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scratch collapse testDiagnostic test
Scratch test performed by the surgeon but with a dynamometer
| Study group | Role | What they receive |
|---|---|---|
| nerve stimulation | Experimental | The test in currently used to search for a nerv compression Receives: Diagnostic Test: Scratch collapse test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the force of external rotation of the elbow
measurement taken before the test and the measurement taken immediately after nerve stimulation according to the SCT. The force is measured with a dynamometer.
Measured: Inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin DEGEORGE, Clinique Saint Jean, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989373
- Sponsor's protocol ID
- 2022-A01972-41
- Status last verified
- May 2024
- First submitted
- 31 May 2023
- Last updated
- 29 May 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scratch Collapse Test: Prospective, Objective, Multi Multicenter
- ClinicalTrials.gov ID
- NCT05989373
- Acronym / sponsor ID
- 2022-A01972-41
- Conditions
- Carpal Tunnel Syndrome, Ulnar Nerve Compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 14 Aug 2023 (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.
Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common pathologies, which are treated surgically.
Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of typical symptoms and an evocative clinical examination. Provocative tests performed in consultation include the Tinel and Phalen sign for the carpal tunnel, and the Tinel and prolonged flexion sign for the ulnar nerve at the elbow.
The Scratch Collapse Test (SCT) has recently emerged as a new provocation test to help diagnose nerve compression in the upper limb.
This non-invasive, pain-free test looks for a reduction in the force of external rotation of the shoulder by applying resistance (the doctor's arm), before and then after a sensory stimulus by "scratching" the area of compression. Nevertheless, this test remains controversial and not based on objective measurements.
Our aim is therefore to assess shoulder external rotation force, and thus TBS, objectively with a dynamometer, before and after stimulation in cases of median nerve compression syndrome at the carpal tunnel and ulnar nerve compression syndrome at the elbow, when these are clinically and electromyographically proven.
This test has already been studied in the literature, but the results in terms of sensitivity and specificity are highly disparate. One study has already published negative results on the subject, with the limitation that the trial was monocentric.
Through this multicenter study, principal investigator wish to highlight the very probable subjectivity of the SCT when it is performed. As the resistance is applied by the physician's arm, the investigator cannot determine the force applied against the patient, unlike with a measurement object. The principal investigator expects this study to refute the notion that external shoulder rotation force decreases after trigger zone stimulation in cases of proven nerve compression syndrome.
The results of this study will thus make it possible to discontinue the use of this technique if it does not help in the diagnosis of compression.
The literature shows a lack of prospective, objective studies involving a large number of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nerve stimulation | Experimental | Diagnostic Test: Scratch collapse testThe test in currently used to search for a nerv compression |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated or entitled to a social security plan
- Patient who has received informed information about the study
- Patient of legal age
- Patient with ulnar nerve or carpal tunnel compression confirmed by EMG during preoperative consultation
Key exclusion criteria (3 listed)
- Recurrence of nerve compression
- Any history that may affect arm sensitivity
- Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scratch collapse testScratch test performed by the surgeon but with a dynamometer | Diagnostic test | nerve stimulation |
Primary outcome
Variation in the force of external rotation of the elbow
Time frame: Inclusion day
measurement taken before the test and the measurement taken immediately after nerve stimulation according to the SCT. The force is measured with a dynamometer.
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 29 May 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Scratch collapse test in people with Carpal Tunnel Syndrome and Ulnar Nerve Compression, run by Clinique Saint Jean, France 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 4 inclusion and 3 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 29 May 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?
Variation in the force of external rotation of the elbow (time frame: Inclusion day). 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 29 May 2024.