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

NCT ID: NCT05989373

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome Ulnar Nerve Compression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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nerve stimulation

The test in currently used to search for a nerv compression

Group Type EXPERIMENTAL

Scratch collapse test

Intervention Type DIAGNOSTIC_TEST

Scratch test performed by the surgeon but with a dynamometer

Interventions

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Scratch collapse test

Scratch test performed by the surgeon but with a dynamometer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean, France

OTHER

Sponsor Role lead

Responsible Party

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Benjamin DEGEORGE

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinique St Jean sud de france

Saint-Jean-de-Védas, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01972-41

Identifier Type: -

Identifier Source: org_study_id

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