Carpal Tunnel SyndromeNCT05861349
Median Nerve Stenosis in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Jakub Antczak at 1 site in Poland.
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?… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Nerve conduction study and Ultrasound
- How many people
- 84 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2023to 3 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Symptoms of CTS
- Electrophysiologic and/or ultrasonographic confirmation of CTS diagnosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College, Department of Neurology
Krakow, Lesser Poland Voivodeship, 31503
About this study
Official title: Utility of the Measurement of Median Nerve Stenosis for Diagnosis of 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?
Read more
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.
Read the 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
- Being tested
- Nerve conduction study, Ultrasound
- Keywords
- Carpal Tunnel Syndrome, ultrasound, nerve compression
- Medical subject headings
- Carpal Tunnel Syndrome, Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve conduction studyDiagnostic test
Nerve conduction study of median and ulnar nerve together with sensory comparative methods on the affected side (sides).
UltrasoundDiagnostic test
Ultrasound of the median nerve on the affected side (sides).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Ultrasound | |
| 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. Receives: Diagnostic Test: Nerve conduction study; Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
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.
Measured: Through study completion, an average of 1 year.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (6)
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.
Measured: 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
Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.
Measured: Through study completion, an average of 1 year.
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.
Measured: 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
Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.
Measured: 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
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.
Measured: 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
Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Nov 2023
- Primary completion29 Feb 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakub Antczak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Agnieszka M Fryźlewicz, MD, Study director, Jagiellonian University Medical College, Department of NeurologyGabriela G Rusin, MD, Study chair, Jagiellonian University Medical College, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861349
- Sponsor's protocol ID
- JagiellonianU71
- Status last verified
- May 2024
- First submitted
- 3 May 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completing the study, the age and gender of participants as well as the scores of BCTQ, the results of NCS and the US images in .jpg and .dicom will be available to other researchers on request.
Publications
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.
PubMed 9325471
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of the Measurement of Median Nerve Stenosis for Diagnosis of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05861349
- Acronym / sponsor ID
- JagiellonianU71
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, ultrasound, nerve compression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jakub AntczakUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with CTS | – | Diagnostic Test: Nerve conduction study, Diagnostic Test: UltrasoundPatients 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. |
| Healthy controls | – | Diagnostic Test: Nerve conduction study, Diagnostic Test: UltrasoundSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Symptoms of CTS
- Electrophysiologic and/or ultrasonographic confirmation of CTS diagnosis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve conduction studyNerve conduction study of median and ulnar nerve together with sensory comparative methods on the affected side (sides). | Diagnostic test | Healthy controls, Patients with CTS |
| UltrasoundUltrasound of the median nerve on the affected side (sides). | Diagnostic test | Healthy controls, Patients with CTS |
Primary outcome
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.
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.
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.
6 secondary outcomes
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 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 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 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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 9325471Padua 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.
- Individual participant dataSharing planned: Yes. After completing the study, the age and gender of participants as well as the scores of BCTQ, the results of NCS and the US images in .jpg and .dicom will be available to other researchers on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka M Fryźlewicz, MD study director
Jagiellonian University Medical College, Department of Neurology
Gabriela G Rusin, MD study chair
Jagiellonian University Medical College, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Jakub Antczak at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the diameter of median nerve in the site of its maximal compression (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05861349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.