Median Nerve Stenosis in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861349
• Other study ID #: JagiellonianU71
• Status: Completed
• Start date: November 1, 2023
• Est. completion date: May 3, 2024

Study information

• Verified date: May 2024
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 3, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College, Department of Neurology	Kraków	Lesser Poland

Sponsors (1)

Lead Sponsor	Collaborator
Jakub Antczak

Country where clinical trial is conducted

Poland, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score	Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.	Through study completion, an average of 1 year.
Secondary	Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score	Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.	Through study completion, an average of 1 year.
Secondary	Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score	Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.	Through study completion, an average of 1 year.
Secondary	Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade	Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.	Through study completion, an average of 1 year.
Secondary	Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity grade	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.	Through study completion, an average of 1 year.
Secondary	Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade	Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.	Through study completion, an average of 1 year.