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

NCT05989373 | Completed

• 1 other identifier: 2022-A01972-41
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Ulnar Nerve Compression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

nerve stimulation

EXPERIMENTAL

The test in currently used to search for a nerv compression

Diagnostic Test: Scratch collapse test

Interventions

Scratch collapse test DIAGNOSTIC_TEST

Scratch test performed by the surgeon but with a dynamometer

nerve stimulation

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recurrence of nerve compression
• Any history that may affect arm sensitivity
• Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique St Jean sud de france

Saint-Jean-de-Védas, 34730, France

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Ulnar Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Ulnar Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)