Carpal Tunnel SyndromeNCT06115187
Correlation of Different Ultrasonographic Indices With Clinical Parameters in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and clinical parameters. The main questions it aims to answer are: To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Nerve ultrasound and Nerve conduction studies
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 1 Mar 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed CTS
Who may be able to join
- Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
- Agreeing to participate in the study
Who cannot join
- Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
- Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
- Not agreeing to participate in the study
- History of surgery due to CTS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi
Istanbul, Uskudar
About this study
The aim of this study is to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and clinical parameters.
The main questions it aims to answer are:
- To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the patient's clinical complaints?
- To what extent are the different ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome correlated with each other?
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. In the diagnosis of CTS, the diagnosis is made electrodiagnostically along with typical clinical findings. However, in recent years, ultrasound has become one of the most preferred methods in the diagnosis of CTS because it is non-invasive, rapid and correlates with electrodiagnostic methods. Diameter, cross-sectional area and echogenicity of the median nerve at the carpal tunnel entrance are the most frequently evaluated parameters in ultrasonographic examination. In different studies, it is aimed to increase the power of ultrasonography in the diagnosis of CTS with various indices created in addition to standardized measurements. The most commonly used ultrasonographic indices, which have been shown to be correlated with electrodiagnostic diagnostic methods, are the wrist-forearm median nerve cross-sectional area ratio, the ratio of median nerve cross-sectional area to carpal tunnel area at the carpal tunnel entry level, and echogenicity assessment. Although the relationship of these indexes, which are reported to have sufficient diagnostic sensitivity and specificity, with the patient's clinical complaints is shown on a measurement basis, there is not enough data on the comparison of different formulas and their correlation with the patient's clinical complaints, including neuropathic pain.Based on this, this study aimed to investigate the relationship between ultrasonographic indices used in patients diagnosed with CTS and clinical parameters.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Nerve ultrasound, Nerve conduction studies
- Keywords
- Carpal tunnel syndrome, Ultrasound, Echogenicity
- 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.
Nerve ultrasoundDiagnostic test
Ultrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels
Nerve conduction studiesDiagnostic test
Upper extremity nerve conduction studies including median-ulnar sensory and motor responses
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients with carpal tunnel syndrome Receives: Diagnostic Test: Nerve ultrasound; Diagnostic Test: Nerve conduction studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the carpal tunnel (mm²)
Measured: 3 months
median nerve ultrasound
Median nerve echogenicity at the level of the carpal tunnel (%)
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)
Measured: 3 months
median nerve ultrasound
Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)
Measured: 3 months
median nerve ultrasound
vertical thickness measurement of the median nerve at the level of the carpal tunnel
Measured: 3 months
Secondary outcomes (8)
Visual analog scale
The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).
Measured: 3 months
Upper extremity nerve conduction studies
Bilateral median and ulnar sensorimotor latency measurement (msec)
Measured: 3 months
Upper extremity nerve conduction studies
Bilateral median and ulnar motor amplitude measurement (mV)
Measured: 3 months
Upper extremity nerve conduction studies
Bilateral median and ulnar sensory amplitude measurement ( µV)
Measured: 3 months
Upper extremity nerve conduction studies
Bilateral median and ulnar sensorimotor conduction velocity measurement (m/sn)
Measured: 3 months
Self Leeds Assessment of Neuropathic Symptoms and Sign
Self Leeds Assessment of Neuropathic Symptoms and Sign is a 7-question scale used to define pain of neuropathic origin and a score of 12 points or more is in favor of the presence of neuropathic pain.The total score ranges from 0 to 24, and higher scores are associated with an increase in neuropathic complaints.
Measured: 3 months
Boston Carpal Tunnel Questionnaire
he Boston Carpal Tunnel Score is a patient-reported questionnaire that examines symptom severity and overall functional status of patients with carpal tunnel syndrome. Two subscores are calculated: Symptom Severity Scale (SSS) and Functional Status Scale (FSS); SSS score range is 11-55, FSS score range is 8-40 and higher scores indicate worse symptoms or function.
Measured: 3 months
hand grip strength
Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start10 Oct 2023
- Primary completion15 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Emre Ata, Assoc.Prof, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115187
- Sponsor's protocol ID
- 23-516
- Status last verified
- Sep 2025
- First submitted
- 24 Oct 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Dataset sharing is not planned
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Different Ultrasonographic Indices With Clinical Parameters in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06115187
- Acronym / sponsor ID
- 23-516
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, Ultrasound, Echogenicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 2 Nov 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 aim of this study is to investigate the relationship between different ultrasonographic indices used in patients with carpal tunnel syndrome and clinical parameters.
The main questions it aims to answer are:
- To what extent are the ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome related to the patient's clinical complaints?
- To what extent are the different ultrasonographic parameters used in the diagnosis of carpal tunnel syndrome correlated with each other?
Detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. In the diagnosis of CTS, the diagnosis is made electrodiagnostically along with typical clinical findings. However, in recent years, ultrasound has become one of the most preferred methods in the diagnosis of CTS because it is non-invasive, rapid and correlates with electrodiagnostic methods. Diameter, cross-sectional area and echogenicity of the median nerve at the carpal tunnel entrance are the most frequently evaluated parameters in ultrasonographic examination. In different studies, it is aimed to increase the power of ultrasonography in the diagnosis of CTS with various indices created in addition to standardized measurements. The most commonly used ultrasonographic indices, which have been shown to be correlated with electrodiagnostic diagnostic methods, are the wrist-forearm median nerve cross-sectional area ratio, the ratio of median nerve cross-sectional area to carpal tunnel area at the carpal tunnel entry level, and echogenicity assessment. Although the relationship of these indexes, which are reported to have sufficient diagnostic sensitivity and specificity, with the patient's clinical complaints is shown on a measurement basis, there is not enough data on the comparison of different formulas and their correlation with the patient's clinical complaints, including neuropathic pain.Based on this, this study aimed to investigate the relationship between ultrasonographic indices used in patients diagnosed with CTS and clinical parameters.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: Nerve ultrasound, Diagnostic Test: Nerve conduction studiesPatients with carpal tunnel syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed CTS
Key inclusion criteria (2 listed)
- Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
- Agreeing to participate in the study
Key exclusion criteria (4 listed)
- Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
- Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
- Not agreeing to participate in the study
- History of surgery due to CTS
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 ultrasoundUltrasonographic evaluation of the median nerve at the carpal tunnel and adjacent levels | Diagnostic test | Patient group |
| Nerve conduction studiesUpper extremity nerve conduction studies including median-ulnar sensory and motor responses | Diagnostic test | Patient group |
Primary outcome
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the carpal tunnel (mm²)
median nerve ultrasound
Time frame: 3 months
Median nerve echogenicity at the level of the carpal tunnel (%)
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the carpal tunnel inlet (mm²)
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the carpal tunnel outlet (mm²)
median nerve ultrasound
Time frame: 3 months
Median nerve cross-sectional area measurement at the level of the pronator quadratus (mm²)
median nerve ultrasound
Time frame: 3 months
vertical thickness measurement of the median nerve at the level of the carpal tunnel
8 secondary outcomes
Visual analog scale
Time frame: 3 months
Upper extremity nerve conduction studies
Time frame: 3 months
Upper extremity nerve conduction studies
Time frame: 3 months
Upper extremity nerve conduction studies
Time frame: 3 months
Upper extremity nerve conduction studies
Time frame: 3 months
Self Leeds Assessment of Neuropathic Symptoms and Sign
Time frame: 3 months
Boston Carpal Tunnel Questionnaire
Time frame: 3 months
hand grip strength
Time frame: 3 months
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 12 Sep 2025.
- Individual participant dataSharing planned: No. Dataset sharing is not planned
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
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Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Emre Ata, Assoc.Prof study chair
Saglik Bilimleri Universitesi
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 Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 12 Sep 2025. 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 Turkey (Türkiye). 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?
median nerve ultrasound (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.