Skip to content

Median Nerve Stenosis in Carpal Tunnel Syndrome

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05861349
Enrollment
84
Registered
2023-05-16
Start date
2023-11-01
Completion date
2024-05-03
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome, ultrasound, nerve compression

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.

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. \[1\].

Interventions

DIAGNOSTIC_TESTNerve conduction study

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

DIAGNOSTIC_TESTUltrasound

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

Sponsors

Jakub Antczak
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Difference in the diameter of median nerve in the site of its maximal compressionThrough 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.
Difference in the cross-sectional area of median nerve in the site of its maximal compressionThrough 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.
Difference in the echogenicity of median nerve in the site of its maximal compressionThrough 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

MeasureTime frameDescription
Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity gradeThrough 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.
Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ scoreThrough 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.
Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity gradeThrough 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.
Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity gradeThrough 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.
Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ scoreThrough 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.
Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ scoreThrough 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026