Clinical trial NCT05861349: Median Nerve Stenosis in Carpal Tunnel Syndrome
Official title: Utility of the Measurement of Median Nerve Stenosis for Diagnosis of Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
ultrasound
nerve compression
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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. \[1\].

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the diameter of median nerve in the site of its maximal compression
timeFrame: Through study completion, an average of 1 year.
measure: Difference in the cross-sectional area of median nerve in the site of its maximal compression
timeFrame: Through study completion, an average of 1 year.
measure: Difference in the echogenicity of median nerve in the site of its maximal compression
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score
timeFrame: Through study completion, an average of 1 year.
measure: Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score
timeFrame: Through study completion, an average of 1 year.
measure: Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score
timeFrame: Through study completion, an average of 1 year.
measure: Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade
timeFrame: Through study completion, an average of 1 year.
measure: Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity grade
timeFrame: Through study completion, an average of 1 year.
measure: Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College, Department of Neurology
state: Lesser Poland
Study officials:
affiliation: Jagiellonian University Medical College, Department of Neurology
name: Agnieszka M Fryźlewicz, MD
role: STUDY_DIRECTOR
affiliation: Jagiellonian University Medical College, Department of Neurology
name: Gabriela G Rusin, MD
role: STUDY_CHAIR
References:
citation: 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.