Median Nerve Stenosis in Carpal Tunnel Syndrome

Sponsor
Jakub Antczak (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05861349
Collaborator
(none)
95
27

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Nerve conduction study
  • Diagnostic Test: Ultrasound

Detailed Description

Carpal tunnel syndrome (CTS) is the most common compression neuropathy. CTS results from the compression of the median nerve in the carpal tunnel. The main symptoms include pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. Nerve conduction studies (NCS) remain the method of choice in diagnosing CTS. However ultrasonography (US) is increasingly used along with or instead of NCS. Most frequently, the increase of the cross-sectional area of the median nerve at the inlet to the carpal tunnel is regarded as the marker of CTS. A number of other measurements such as median nerve mobility, volar bulging of flexor retinaculum and others were also studied to increase diagnostic sensitivity and specificity. In this study the investigators aim to assess the utility of measurements made at the point of the maximal stenosis of the median nerve in the tunnel to diagnose CTS. So far, there were only few studies, which visualized the maximal nerve stenosis, which is the essential pathological feature of CTS. In general, the group of patients with CTS and controls will undergo NCS of symptomatic median and ipsilateral ulnar nerves and US of the symptomatic median nerve with measurements of the cross-sectional area, diameter and echogenicity at various points, including the point of the maximal stenosis. The location of the maximal stenosis with respect to external (distal crease) and internal (wrist and hand bones and thenar musculature) will also be evaluated. Subjects will also be asked to fill out the Boston Carpal Tunnel Questionnaire (BCTQ) and a demographic questionnaire. US measurements will be compared between patients and healthy volunteers. US measurements, especially those made at the point of stenosis will be correlated among patients with clinical severity of CTS, reflected by the score in BCTQ and with the grade of electrophysiological severity as introduced by Padua et al. [1].

Study Design

Study Type:
Observational
Anticipated Enrollment :
95 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Utility of the Measurement of Median Nerve Stenosis for Diagnosis of Carpal Tunnel Syndrome
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Nov 30, 2025

Arms and Interventions

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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Difference in the diameter of median nerve in the site of its maximal compression [Through study completion, an average of 1 year.]

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

  2. Difference in the cross-sectional area of median nerve in the site of its maximal compression [Through study completion, an average of 1 year.]

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

  3. Difference in the echogenicity of median nerve in the site of its maximal compression [Through study completion, an average of 1 year.]

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

Secondary Outcome Measures

  1. 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 diameter of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.

  2. 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 the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.

  3. 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 echogenicity of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.

  4. 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 diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.

  5. 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.]

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

  6. Correlation of echogenicity 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 echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Symptoms of CTS

  • Electrophysiologic and/or ultrasonographic confirmation of CTS diagnosis

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jakub Antczak

Investigators

  • Study Director: Agnieszka M Fry┼║lewicz, MD, Jagiellonian University Medical College, Department of Neurology
  • Study Chair: Gabriela G Rusin, MD, Jagiellonian University Medical College, Department of Neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jakub Antczak, Principal Investigator, Jagiellonian University
ClinicalTrials.gov Identifier:
NCT05861349
Other Study ID Numbers:
  • JagiellonianU71
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jakub Antczak, Principal Investigator, Jagiellonian University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 16, 2023