Median Nerve Stenosis in Carpal Tunnel Syndrome

NCT ID: NCT05861349

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-05-03

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].

Conditions

Carpal Tunnel Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Nerve conduction study

Intervention Type: DIAGNOSTIC_TEST

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

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Nerve conduction study

Intervention Type: DIAGNOSTIC_TEST

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

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Nerve conduction study

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

Intervention Type: DIAGNOSTIC_TEST

Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jakub Antczak

OTHER

Sponsor Role: lead

Responsible Party

Jakub Antczak

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Agnieszka M Fryźlewicz, MD

Role: STUDY_DIRECTOR

Jagiellonian University Medical College, Department of Neurology

Gabriela G Rusin, MD

Role: STUDY_CHAIR

Jagiellonian University Medical College, Department of Neurology

Locations

Jagiellonian University Medical College, Department of Neurology

Krakow, Lesser Poland Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 9325471 (View on PubMed)

Other Identifiers

JagiellonianU71

Identifier Type: -

Identifier Source: org_study_id