Carpal Tunnel Syndrome (CTS)UE-CTSNCT07486284
Ultrasound Elastography of Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS), run by Da Nang Family General Hospital at 1 site in Vietnam.
Trial summary
Carpal Tunnel Syndrome (CTS) is the most common peripheral nerve compression disorder in adults. Although electromyography (EMG) is the current gold standard for diagnosis, it is invasive, time-consuming, and may yield false-negative results. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Ultrasound Elastography
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Apr 2025to 15 Apr 2026
- How long will I take part?
- 50 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Clinical suspicion of CTS with at least one sign: numbness/pain in the median nerve distribution (digits 1, 2, 3, and lateral 4), nocturnal symptoms, or positive provocative tests (Tinel, Phalen, Durkan). Confirmed diagnosis of CTS via Electrodiagnostic studies (NCS/EMG) based on American Academy of Neurology (AAN) and AANEM criteria.
Who may be able to join
- Patients >18 years old.
- Clinical suspicion of CTS with at least one sign: numbness/pain in the median nerve distribution (digits 1, 2, 3, and lateral 4), nocturnal symptoms, or positive provocative tests (Tinel, Phalen, Durkan).
- Confirmed diagnosis of CTS via Electrodiagnostic studies (NCS/EMG) based on American Academy of Neurology (AAN) and AANEM criteria.
- Healthy volunteers with no clinical symptoms of CTS.
- Normal electrodiagnostic results.
Who cannot join
- History of prior CTS treatment (steroid injection, surgery).
- Presence of cervical radiculopathy, polyneuropathy, or proximal median nerve entrapment.
- Secondary causes of CTS identified on ultrasound (e.g., gouty tophi, ganglion cysts, tumors, tenosynovitis).
- Anatomical variants such as a bifid median nerve or persistent median artery.
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Characteristics of Ultrasound Elastography in the Evaluation of Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) is the most common peripheral nerve compression disorder in adults. Although electromyography (EMG) is the current gold standard for diagnosis, it is invasive, time-consuming, and may yield false-negative results. Ultrasound elastography, including shear wave elastography and strain elastography, enables non-invasive assessment of median nerve stiffness, reflecting fibrosis and edema. However, data on the combined use of elastography and microvascular imaging in CTS are still limited in Vietnam. This study aims to evaluate the value of advanced ultrasound techniques in diagnosing CTS and grading disease severity, as well as their correlation with clinical symptoms and EMG findings
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Ultrasound Elastography
- Keywords
- Carpal Tunnel Syndrome, Ultrasound Elastography
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ElastographyProcedure or surgery
- Shear Wave Elastography (SWE):
- Performed in the longitudinal plane at the carpal tunnel inlet.
- A Region of Interest (ROI) of 1mm will be placed on the median nerve (excluding epineurium).
- Stiffness will be measured in kilopascals (kPa).
- Three measurements will be taken and averaged.
- Strain Elastography (SE):
- Assessed using a color map overlay (Blue/Green/Red).
- Grading scale (1-4): Grade 1 (Soft/Red) to Grade 4 (Hardest/Blue).
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of shear wave elastography values (kPa) for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.
Measured: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Diagnostic Accuracy of Strain Elastography (SE) for Carpal Tunnel Syndrome
Sensitivity, specificity, and AUC of strain elastography grading for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.
Measured: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Diagnostic Accuracy of Median Nerve Cross-Sectional Area (CSA) for Carpal Tunnel Syndrome
Sensitivity, specificity, and AUC of median nerve cross-sectional area (mm²) measured at the carpal tunnel inlet for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.
Measured: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Secondary outcomes (2)
Correlation
Correlation coefficients (Pearson/Spearman) between ultrasound parameters (Stiffness, CSA) and:
- Electrophysiological severity (DML, SCV, SNAP amplitudes).
- Clinical severity (Boston scores).
Measured: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Cut-off Values
Optimal threshold values for SWE (kPa) and CSA (mm2) to distinguish CTS from controls and to classify severity.
Measured: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start15 Apr 2025
- Primary completion20 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
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 Syndrome (CTS)Studies 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 50 Months
Sponsor and investigators
- Lead sponsor
- Da Nang Family General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nguyen Do Ngoc Linh, MD, Study director, Da Nang Family General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486284
- Sponsor's protocol ID
- 01/2025/BVGĐ-HĐĐĐ
- Other IDs
- 01/2025/BVGĐ-HĐĐĐ
- Acronym
- UE-CTS
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. El-Shewi, Islam El-Hefnawi et al. (2024), "Role of conventional ultrasound and shear wave elastography of median nerve in diagnosis and differentiation of carpal tunnel syndrome severity in correlation with electrodiagnostic studies", Egyptian Journal of Radiology and Nuclear Medicine. 55(1), tr. 53. 2. Joshi, Aditya et al. (2022), "Carpal tunnel syndrome: pathophysiology and comprehensive guidelines for clinical evaluation and treatment", Cureus. 14(7). 3. Schrier, Verena JMM et al. (2020), "Shear wave elastography of the median nerve: a mechanical study", Muscle & Nerve. 61(6), tr. 826-833. 4. Sernik, Renato Antonio et al. (2023), "Shear wave elastography is a valuable tool for diagnosing and grading carpal tunnel syndrome", Skeletal radiology. 52(1), tr. 67-72. 5. Wu, Han et al. (2022), "Ultrasound and elastography role in pre-and post-operative evaluation of median neuropathy in patients with carpal tunnel syndrome", Frontiers in Neurology. 13, tr. 1079737.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Characteristics of Ultrasound Elastography in the Evaluation of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07486284
- Acronym / sponsor ID
- UE-CTS / 01/2025/BVGĐ-HĐĐĐ
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal Tunnel Syndrome, Ultrasound Elastography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Da Nang Family General HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 20 Mar 2026 (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.
Carpal Tunnel Syndrome (CTS) is the most common peripheral nerve compression disorder in adults. Although electromyography (EMG) is the current gold standard for diagnosis, it is invasive, time-consuming, and may yield false-negative results. Ultrasound elastography, including shear wave elastography and strain elastography, enables non-invasive assessment of median nerve stiffness, reflecting fibrosis and edema. However, data on the combined use of elastography and microvascular imaging in CTS are still limited in Vietnam. This study aims to evaluate the value of advanced ultrasound techniques in diagnosing CTS and grading disease severity, as well as their correlation with clinical symptoms and EMG findings
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 50 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical suspicion of CTS with at least one sign: numbness/pain in the median nerve distribution (digits 1, 2, 3, and lateral 4), nocturnal symptoms, or positive provocative tests (Tinel, Phalen, Durkan). Confirmed diagnosis of CTS via Electrodiagnostic studies (NCS/EMG) based on American Academy of Neurology (AAN) and AANEM criteria.
Key inclusion criteria (5 listed)
- Patients >18 years old.
- Clinical suspicion of CTS with at least one sign: numbness/pain in the median nerve distribution (digits 1, 2, 3, and lateral 4), nocturnal symptoms, or positive provocative tests (Tinel, Phalen, Durkan).
- Confirmed diagnosis of CTS via Electrodiagnostic studies (NCS/EMG) based on American Academy of Neurology (AAN) and AANEM criteria.
- Healthy volunteers with no clinical symptoms of CTS.
- Normal electrodiagnostic results.
Key exclusion criteria (5 listed)
- History of prior CTS treatment (steroid injection, surgery).
- Presence of cervical radiculopathy, polyneuropathy, or proximal median nerve entrapment.
- Secondary causes of CTS identified on ultrasound (e.g., gouty tophi, ganglion cysts, tumors, tenosynovitis).
- Anatomical variants such as a bifid median nerve or persistent median artery.
- Refusal to participate in the study
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 |
|---|---|---|
| Ultrasound Elastography* Shear Wave Elastography (SWE): * Performed in the longitudinal plane at the carpal tunnel inlet. * A Region of Interest (ROI) of 1mm will be placed on the median nerve (excluding epineurium). * Stiffness will be measured in kilopascals (kPa). * Three measurements will be taken and averaged. * Strain Elastography (SE): * Assessed using a color map overlay (Blue/Green/Red). * Grading scale (1-4): Grade 1 (Soft/Red) to Grade 4 (Hardest/Blue). | Procedure or surgery | – |
Primary outcome
Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome
Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of shear wave elastography values (kPa) for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.
Diagnostic Accuracy of Strain Elastography (SE) for Carpal Tunnel Syndrome
Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Sensitivity, specificity, and AUC of strain elastography grading for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.
Diagnostic Accuracy of Median Nerve Cross-Sectional Area (CSA) for Carpal Tunnel Syndrome
Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Sensitivity, specificity, and AUC of median nerve cross-sectional area (mm²) measured at the carpal tunnel inlet for diagnosing carpal tunnel syndrome using electrodiagnostic testing as the reference standard.
2 secondary outcomes
Correlation
Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Cut-off Values
Time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication1. El-Shewi, Islam El-Hefnawi et al. (2024), "Role of conventional ultrasound and shear wave elastography of median nerve in diagnosis and differentiation of carpal tunnel syndrome severity in correlation with electrodiagnostic studies", Egyptian Journal of Radiology and Nuclear Medicine. 55(1), tr. 53. 2. Joshi, Aditya et al. (2022), "Carpal tunnel syndrome: pathophysiology and comprehensive guidelines for clinical evaluation and treatment", Cureus. 14(7). 3. Schrier, Verena JMM et al. (2020), "Shear wave elastography of the median nerve: a mechanical study", Muscle & Nerve. 61(6), tr. 826-833. 4. Sernik, Renato Antonio et al. (2023), "Shear wave elastography is a valuable tool for diagnosing and grading carpal tunnel syndrome", Skeletal radiology. 52(1), tr. 67-72. 5. Wu, Han et al. (2022), "Ultrasound and elastography role in pre-and post-operative evaluation of median neuropathy in patients with carpal tunnel syndrome", Frontiers in Neurology. 13, tr. 1079737.
- Individual participant dataSharing planned: No
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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.
Nguyen Do Ngoc Linh, MD study director
Da Nang Family General Hospital
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 (CTS), run by Da Nang Family General Hospital at 1 site in Vietnam.
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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Accuracy of Shear Wave Elastography for Carpal Tunnel Syndrome (time frame: At baseline (data collected at the time of retinal examination during the study period from April 2025 to February 2026)). 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 NCT07486284, 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 20 Mar 2026.