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

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.

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 Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Ulnar Nerve Compression
• Intervention / Treatment: Diagnostic test: Scratch collapse test

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Jean-de-Védas, France, 34730
    • Clinique St Jean Sud de france

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion day

Collaborators and Investigators

• Sponsor: Clinique Saint Jean, France

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Neuropathies; Carpal Tunnel Syndrome; Ulnar Nerve Compression Syndromes
• Other Study ID Numbers: 2022-A01972-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No