Skip to main content
OpenTrials
Completed

NCT Number: NCT05861349

Median Nerve Stenosis in Carpal Tunnel Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jagiellonian University Medical College, Department of Neurology

Krakow, Lesser Poland Voivodeship, 31503, Poland

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nerve Conduction Study

Diagnostic Test

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

Ultrasound

Diagnostic Test

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

Primary outcomes

  1. Difference in the diameter of median nerve in the site of its maximal compression

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jakub Antczak

Other

Registry information

Official study title

Utility of the Measurement of Median Nerve Stenosis for Diagnosis of Carpal Tunnel Syndrome

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.