Median Nerve Stenosis in Carpal Tunnel Syndrome

NCT05861349 | Completed

• 1 other identifier: JagiellonianU71
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to test the new kind of ultrasound-based measurements in patients with carpal tunnel syndrome. The main questions it aims to answer are:

• Do the measurements of the size of the median nerve at the point where it is maximally compressed accurately diagnose carpal tunnel syndrome?
• May these measurements accurately tell how severe is the carpal tunnel syndrome? Participants will be asked to:
• Undergo conduction studies of median and ulnar nerve.
• Undergo ultrasound of the median nerve.
• Fill out the Boston carpal tunnel questionnaire and a demographic questionnaire. Researchers will compare the group of patients with carpal tunnel syndrome with healthy volunteers to see if respective measurements differ significantly between groups.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; ultrasound; nerve compression

Outcome Measures

Primary Outcomes (3)

• Difference in the diameter of median nerve in the site of its maximal compression

  Difference in the diameter of median nerve in the site of its maximal compression between patients with CTS and healthy controls.

  Through study completion, an average of 1 year.

• Difference in the cross-sectional area of median nerve in the site of its maximal compression

  Difference in the cross-sectional area of median nerve in the site of its maximal compression between patients with CTS and healthy controls.

  Through study completion, an average of 1 year.

• Difference in the echogenicity of median nerve in the site of its maximal compression

  Difference in the echogenicity of median nerve in the site of its maximal compression between patients with CTS and healthy controls.

  Through study completion, an average of 1 year.

Secondary Outcomes (6)

• Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score

  Through study completion, an average of 1 year.

• Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score

  Through study completion, an average of 1 year.

• Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score

  Through study completion, an average of 1 year.

• Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade

  Through study completion, an average of 1 year.

• Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity grade

  Through study completion, an average of 1 year.

Study Arms (2)

Patients with CTS

Patients referred to the Electromyographic Laboratory of the Department of Neurology at the Jagiellonian University Medical College, Cracow, Poland with symptoms suggestive of CTS (numbness of the hand, present or accentuated in the night, reduced hand dexterity) with CTS confirmed in NCS or US.

Diagnostic Test: Nerve conduction study; Diagnostic Test: Ultrasound

Healthy controls

Subjects referred to the Electromyographic Laboratory of the Department of Neurology at the Jagiellonian University Medical College, Cracow, Poland for investigation towards tetany, with no or only weak signs of tetany in electromyography.

Diagnostic Test: Nerve conduction study; Diagnostic Test: Ultrasound

Interventions

Nerve conduction study DIAGNOSTIC_TEST

Nerve conduction study of median and ulnar nerve together with sensory comparative methods on the affected side (sides).

Healthy controls; Patients with CTS

Ultrasound DIAGNOSTIC_TEST

Ultrasound of the median nerve on the affected side (sides).

Healthy controls; Patients with CTS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the patients referred to the EMG Laboratory of the Department of Neurology at Jagiellonian University Medical College for verification of clinical diagnosis of CTS. After NCS and/or US confirms the CTS, the patient will be asked if she/he would like to take part in the study. Healthy controls will be recruited from the patients referred for verification of clinical diagnosis of tetany, after EMG reveals weak tetany or does not confirm it.

You may qualify if:

• Symptoms of CTS
• Electrophysiologic and/or ultrasonographic confirmation of CTS diagnosis

You may not qualify if:

• Psychiatric or cognitive conditions with may disturb participation in the study
• Peripheral neuropathy in history
• Fractures and severe trauma in the area of the wrist in history

Sponsors & Collaborators

• Jakub Antczak: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Neurology

Krakow, Lesser Poland Voivodeship, 31503, Poland

Location

Related Publications (1)

• Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.

  PMID: 9325471 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Neuroma

Interventions

Nerve Conduction Studies; Ultrasonography

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; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Diagnostic Imaging

Study Officials

• Agnieszka M Fryźlewicz, MD

  Jagiellonian University Medical College, Department of Neurology

  STUDY DIRECTOR

• Gabriela G Rusin, MD

  Jagiellonian University Medical College, Department of Neurology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 16, 2023
• Study Start: November 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: May 3, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available after the study results will be published.
• Access Criteria: On request sent by e-mail to jakub.antczak@uj.edu.pl

Locations

PL (1)