Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.
Primary Purpose
Carpal Tunnel Syndrome, Ulnar Nerve Compression
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Scratch collapse test
Sponsored by
About this trial
This is an interventional diagnostic trial for Carpal Tunnel Syndrome
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Recurrence of nerve compression Any history that may affect arm sensitivity Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)
Sites / Locations
- Clinique St Jean sud de franceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nerve stimulation
Arm Description
The test in currently used to search for a nerv compression
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05989373
First Posted
May 31, 2023
Last Updated
August 9, 2023
Sponsor
Clinique Saint Jean, France
1. Study Identification
Unique Protocol Identification Number
NCT05989373
Brief Title
Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.
Official Title
Scratch Collapse Test: Prospective, Objective, Multi Multicenter
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Saint Jean, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Ulnar Nerve Compression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nerve stimulation
Arm Type
Experimental
Arm Description
The test in currently used to search for a nerv compression
Intervention Type
Diagnostic Test
Intervention Name(s)
Scratch collapse test
Intervention Description
Scratch test performed by the surgeon but with a dynamometer
Primary Outcome Measure Information:
Title
Variation in the force of external rotation of the elbow
Description
measurement taken before the test and the measurement taken immediately after nerve stimulation according to the SCT. The force is measured with a dynamometer.
Time Frame
Inclusion day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Recurrence of nerve compression
Any history that may affect arm sensitivity
Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)
Facility Information:
Facility Name
Clinique St Jean sud de france
City
Saint-Jean-de-Védas
ZIP/Postal Code
34730
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Spirito
Phone
0033688644120
Email
cecile.spirito@capsante.fr
First Name & Middle Initial & Last Name & Degree
Benjamin Degeorge
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.
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