Carpal Tunnel Syndrome (CTS)CTS-PDNCT07433166
Ultrasound Evaluation in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome (CTS), run by SB Istanbul Education and Research Hospital.
Trial summary
This prospective cohort study aims to evaluate median nerve cross-sectional area and intraneural vascularity using power Doppler ultrasonography in patients with carpal tunnel syndrome. Ultrasonographic findings will be compared between diabetic and non-diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Doppler ultrasound
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jan 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Carpal Tunnel Syndrome Patients
Who may be able to join
- clinically and electrophysiologically confirmed carpal tunnel syndrome
- symptom duration > 3 months
- written informed consent
Who cannot join
- previous wrist surgery
- cervical radiculopathy
- inflammatory arthritis
- pregnancy
About this study
Official title: Prospective Evaluation of Median Nerve Cross-Sectionall Area and Power Doppler Signal Changes in Patients With Carpal Tunnel Syndrome
This prospective cohort study aims to evaluate median nerve cross-sectional area and intraneural vascularity using power Doppler ultrasonography in patients with carpal tunnel syndrome. Ultrasonographic findings will be compared between diabetic and non-diabetic patients. Clinical severity and electrophysiological findings will be correlated with ultrasonographic parameters.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Doppler ultrasound
- Keywords
- carpal tunnel, ultrasound, power doppler
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDiagnostic test
The predictive power of cross-sectional area and intraneural blood flow measured by ultrasound on surgical outcomes will be tested.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraneural Vascularity
Intraneural blood flow will be evaluated using power Doppler ultrasonography at the level of the carpal tunnel inlet. The presence and degree of intraneural vascularity will be graded using a semi-quantitative scoring system:
0 = No detectable intraneural flow
- = Single vessel signal
- = Multiple vessel signals
- = Marked hypervascularity
The total score ranges from 0 to 3. Higher scores indicate increased intraneural vascularity.
Measured: Baseline
Cross sectional Area
The cross-sectional area of the median nerve will be measured using ultrasonography at the level of the pisiform bone (carpal tunnel inlet) and proximal to transvers carpal ligament. Measurements will be obtained by tracing the inner border of the hyperechoic epineurium.
Values will be recorded in square millimeters (mm²). Higher values indicate greater nerve swelling.
Measured: baseline
Secondary outcomes (1)
Boston Carpal Tunnel Questionnaire
Change in Symptom Severity Score of the Boston Carpal Tunnel Questionnaire The Boston Carpal Tunnel Questionnaire is a patient-reported outcome measure consisting of 11 questions assessing symptom severity. Each item is scored from 1 (no symptoms) to 5 (most severe symptoms). The total score ranges from 11 to 55. Higher scores indicate worse symptom severity.
Measured: Baseline, 3th and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Acar, SB Istanbul Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433166
- Sponsor's protocol ID
- CTS-PD-DM-2026
- Acronym
- CTS-PD
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not planned due to patient confidentially and instutional policy
Publications
Erickson M, Lawrence M, Lucado A. The role of diagnostic ultrasound in the examination of carpal tunnel syndrome: an update and systematic review. J Hand Ther. 2022 Apr-Jun;35(2):215-225. doi: 10.1016/j.jht.2021.04.014. Epub 2021 Apr 14.
PubMed 34261588
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Median Nerve Cross-Sectionall Area and Power Doppler Signal Changes in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07433166
- Acronym / sponsor ID
- CTS-PD / CTS-PD-DM-2026
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- carpal tunnel, ultrasound, power doppler
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Feb 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.
This prospective cohort study aims to evaluate median nerve cross-sectional area and intraneural vascularity using power Doppler ultrasonography in patients with carpal tunnel syndrome. Ultrasonographic findings will be compared between diabetic and non-diabetic patients. Clinical severity and electrophysiological findings will be correlated with ultrasonographic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Carpal Tunnel Syndrome Patients
Key inclusion criteria (3 listed)
- clinically and electrophysiologically confirmed carpal tunnel syndrome
- symptom duration > 3 months
- written informed consent
Key exclusion criteria (4 listed)
- previous wrist surgery
- cervical radiculopathy
- inflammatory arthritis
- pregnancy
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 |
|---|---|---|
| Doppler ultrasoundThe predictive power of cross-sectional area and intraneural blood flow measured by ultrasound on surgical outcomes will be tested. | Diagnostic test | – |
Primary outcome
Intraneural Vascularity
Time frame: Baseline
Intraneural blood flow will be evaluated using power Doppler ultrasonography at the level of the carpal tunnel inlet. The presence and degree of intraneural vascularity will be graded using a semi-quantitative scoring system: 0 = No detectable intraneural flow 1. = Single vessel signal 2. = Multiple vessel signals 3. = Marked hypervascularity The total score ranges from 0 to 3. Higher scores indicate increased intraneural vascularity.
Cross sectional Area
Time frame: baseline
The cross-sectional area of the median nerve will be measured using ultrasonography at the level of the pisiform bone (carpal tunnel inlet) and proximal to transvers carpal ligament. Measurements will be obtained by tracing the inner border of the hyperechoic epineurium. Values will be recorded in square millimeters (mm²). Higher values indicate greater nerve swelling.
1 secondary outcome
Boston Carpal Tunnel Questionnaire
Time frame: Baseline, 3th and 6th months
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 9 Apr 2026.
- Background: PubMed 34261588Erickson M, Lawrence M, Lucado A. The role of diagnostic ultrasound in the examination of carpal tunnel syndrome: an update and systematic review. J Hand Ther. 2022 Apr-Jun;35(2):215-225. doi: 10.1016/j.jht.2021.04.014. Epub 2021 Apr 14.
- Individual participant dataSharing planned: No. Data sharing is not planned due to patient confidentially and instutional policy
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome (CTS), run by SB Istanbul Education and Research Hospital.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Intraneural Vascularity (time frame: Baseline). The study lists 2 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 NCT07433166, 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 9 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.