Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.

Sponsor
Clinique Saint Jean, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05989373
Collaborator
(none)
250
1
1
2
124.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Scratch collapse test
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Scratch Collapse Test: Prospective, Objective, Multi Multicenter
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nerve stimulation

The test in currently used to search for a nerv compression

Diagnostic Test: Scratch collapse test
Scratch test performed by the surgeon but with a dynamometer

Outcome Measures

Primary Outcome Measures

  1. Variation in the force of external rotation of the elbow [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique St Jean sud de france Saint-Jean-de-Védas France 34730

Sponsors and Collaborators

  • Clinique Saint Jean, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Benjamin DEGEORGE, Principal investigator, Clinique Saint Jean, France
ClinicalTrials.gov Identifier:
NCT05989373
Other Study ID Numbers:
  • 2022-A01972-41
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023