Carpal Tunnel SyndromeCTS-US-WEIGHTNCT07508397
Median Nerve Cross-Sectional Area and Body Weight in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome and Entrapment Neuropathies, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the diagnostic accuracy of ultrasonographic measurements of the median nerve in patients with Carpal Tunnel Syndrome (CTS). While ultrasound is a common diagnostic tool, various physical factors can influence its results. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Entrapment Neuropathies, Median Nerve Compression
- What is being tested?
- High-Resolution Ultrasonography and Electrophysiological Evaluation
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2025to 11 Jun 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients who were admitted to the Physical and Rehabilitation Medicine (PMR) outpatient clinic with complaints of hand numbness and tingling. The cohort includes individuals from a diverse range of occupational backgrounds and body compositions to evaluate the impact of anthropometric measurements on median nerve morphology.
Who may be able to join
- Patients aged between 18 and 75 years.
- Clinical diagnosis of Carpal Tunnel Syndrome (CTS) based on symptoms (numbness, tingling, nocturnal pain in the median nerve distribution).
- Electrophysiological confirmation of CTS according to the American
- Association of Neuromuscular \& Electrodiagnostic Medicine (AAEM) criteria.
- Ability to provide written informed consent.
Who cannot join
- Secondary causes of CTS (e.g., Diabetes Mellitus, Hypothyroidism, Rheumatoid -Arthritis, Chronic Renal Failure).
- Coexisting neurological conditions (e.g., Cervical Radiculopathy,
- Polyneuropathy, Brachial Plexopathy).
- History of previous wrist surgery, trauma, or local corticosteroid injection within the last 6 months.
- Pregnancy or lactation.
- Congenital anatomical variations such as a bifid median nerve or persistent median artery (detected during USG).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Hospital, Department of Physical Medicine and Rehabilitation
Kayseri, 38080
About this study
Official title: The Relationship Between Ultrasonographic Median Nerve Cross-Sectional Area and Electrophysiological Severity in Carpal Tunnel Syndrome Diagnosis: The Masking Role of Body Weight
This study aims to evaluate the diagnostic accuracy of ultrasonographic measurements of the median nerve in patients with Carpal Tunnel Syndrome (CTS). While ultrasound is a common diagnostic tool, various physical factors can influence its results. The researchers will investigate how a patient's absolute body weight and Body Mass Index (BMI) affect the size of the median nerve cross-sectional area across different stages of disease severity. The goal is to determine if absolute body weight plays a 'masking' role that could lead to more precise diagnostic interpretations in clinical practice.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and while electrodiagnostic studies (NCS/EMG) remain the gold standard, ultrasonography (USG) has gained popularity as a non-invasive diagnostic tool. However, the correlation between median nerve cross-sectional area (CSA) and electrophysiological severity can be inconsistent due to anthropometric variations.
In this prospective observational study involving 120 participants, the researchers will perform high-resolution ultrasonographic measurements of the median nerve at the level of the pisiform bone. All patients will undergo standardized nerve conduction studies to be classified into mild, moderate, or severe CTS stages according to AAEM criteria.
The study specifically focuses on the 'masking hypothesis,' which suggests that absolute body weight may have a more significant impact on nerve morphological changes than the ratio-based BMI, particularly during the progression from mild to moderate stages. By analyzing these relationships using non-parametric statistical methods, the study seeks to improve the reliability of USG-based diagnostics in diverse patient populations.
- Being tested
- High-Resolution Ultrasonography and Electrophysiological Evaluation
- Keywords
- Ultrasonography, Median Nerve, Cross-Sectional Area, Body Weight, Body Mass Index (BMI), Electromyography, Diagnostic Accuracy, Physical and Rehabilitation Medicine
- Medical subject headings
- Carpal Tunnel Syndrome, Nerve Compression Syndromes, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Resolution Ultrasonography and Electrophysiological EvaluationDiagnostic test
Also called Ultrasonography, Nerve Conduction Studies (NCS)
Participants underwent a high-resolution ultrasonographic examination using a high-frequency linear probe to measure the median nerve cross-sectional area (CSA) at the level of the pisiform bone. Subsequently, standardized electrophysiological evaluations (motor distal latency and sensory conduction velocity) were performed to classify CTS severity according to AAEM criteria.
| Study group | Role | What they receive |
|---|---|---|
| CTS Patient Cohort | Patients aged 18-75 years who were clinically and electrophysiologically diagnosed with idiopathic Carpal Tunnel Syndrome. This single cohort includes patients across all severity stages (mild, moderate, and severe) to evaluate the relationship between median nerve morphology and anthropometric measurements. Receives: Diagnostic Test: High-Resolution Ultrasonography and Electrophysiological Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Nerve Cross-Sectional Area (CSA)
The cross-sectional area of the median nerve measured in square millimeters using high-resolution ultrasonography at the level of the pisiform bone. This measurement is the primary tool for morphological evaluation of the nerve.
Measured: At the time of enrollment (single measurement)
Secondary outcomes (2)
Electrophysiological Severity Grading
The reported outcome is a single categorical variable representing CTS severity (Mild, Moderate, or Severe). This severity grade is determined by aggregating multiple standard Nerve Conduction Study (NCS) parameters (such as motor distal latency and sensory conduction velocity) into a single classification based on the established AAEM criteria.
Measured: At the time of enrollment (single measurement)
Anthropometric Measurements (Absolute Body Weight and BMI)
Measurement of the participant's absolute body weight (kg) and Body Mass Index to analyze their respective correlations with median nerve CSA and disease severity stages.
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start29 Apr 2025
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Other
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Goktug Yazar, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508397
- Sponsor's protocol ID
- 2025-427
- Acronym
- CTS-US-WEIGHT
- Status last verified
- Nov 2026
- First submitted
- 24 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers to ensure the confidentiality and privacy of the study participants in accordance with local ethical guidelines and national data protection laws (KVKK). The aggregated results and statistical analyses will be made available through the final publication. Specific requests for data may be evaluated by the Principal Investigator upon reasonable request and institutional approval.
Publications
Cartwright MS, Hobson-Webb LD, Boon AJ, Alter KE, Hunt CH, Flores VH, Werner RA, Shook SJ, Thomas TD, Primack SJ, Walker FO; American Association of Neuromuscular and Electrodiagnostic Medicine. Evidence-based guideline: neuromuscular ultrasound for the diagnosis of carpal tunnel syndrome. Muscle Nerve. 2012 Aug;46(2):287-93. doi: 10.1002/mus.23389.
PubMed 22806381Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome [RETIRED]. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2002 Jun 11;58(11):1589-92. doi: 10.1212/wnl.58.11.1589. No abstract available.
PubMed 12058083
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Ultrasonographic Median Nerve Cross-Sectional Area and Electrophysiological Severity in Carpal Tunnel Syndrome Diagnosis: The Masking Role of Body Weight
- ClinicalTrials.gov ID
- NCT07508397
- Acronym / sponsor ID
- CTS-US-WEIGHT / 2025-427
- Keywords
- Ultrasonography, Median Nerve, Cross-Sectional Area, Body Weight, Body Mass Index (BMI), Electromyography, Diagnostic Accuracy, Physical and Rehabilitation Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 2 Apr 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 study aims to evaluate the diagnostic accuracy of ultrasonographic measurements of the median nerve in patients with Carpal Tunnel Syndrome (CTS). While ultrasound is a common diagnostic tool, various physical factors can influence its results. The researchers will investigate how a patient's absolute body weight and Body Mass Index (BMI) affect the size of the median nerve cross-sectional area across different stages of disease severity. The goal is to determine if absolute body weight plays a 'masking' role that could lead to more precise diagnostic interpretations in clinical practice.
Detailed description
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy, and while electrodiagnostic studies (NCS/EMG) remain the gold standard, ultrasonography (USG) has gained popularity as a non-invasive diagnostic tool. However, the correlation between median nerve cross-sectional area (CSA) and electrophysiological severity can be inconsistent due to anthropometric variations.
In this prospective observational study involving 120 participants, the researchers will perform high-resolution ultrasonographic measurements of the median nerve at the level of the pisiform bone. All patients will undergo standardized nerve conduction studies to be classified into mild, moderate, or severe CTS stages according to AAEM criteria.
The study specifically focuses on the 'masking hypothesis,' which suggests that absolute body weight may have a more significant impact on nerve morphological changes than the ratio-based BMI, particularly during the progression from mild to moderate stages. By analyzing these relationships using non-parametric statistical methods, the study seeks to improve the reliability of USG-based diagnostics in diverse patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTS Patient Cohort | – | Diagnostic Test: High-Resolution Ultrasonography and Electrophysiological EvaluationPatients aged 18-75 years who were clinically and electrophysiologically diagnosed with idiopathic Carpal Tunnel Syndrome. This single cohort includes patients across all severity stages (mild, moderate, and severe) to evaluate the relationship between median nerve morphology and anthropometric measurements. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients who were admitted to the Physical and Rehabilitation Medicine (PMR) outpatient clinic with complaints of hand numbness and tingling. The cohort includes individuals from a diverse range of occupational backgrounds and body compositions to evaluate the impact of anthropometric measurements on median nerve morphology.
Key inclusion criteria (5 listed)
- Patients aged between 18 and 75 years.
- Clinical diagnosis of Carpal Tunnel Syndrome (CTS) based on symptoms (numbness, tingling, nocturnal pain in the median nerve distribution).
- Electrophysiological confirmation of CTS according to the American
- Association of Neuromuscular \& Electrodiagnostic Medicine (AAEM) criteria.
- Ability to provide written informed consent.
Key exclusion criteria (6 listed)
- Secondary causes of CTS (e.g., Diabetes Mellitus, Hypothyroidism, Rheumatoid -Arthritis, Chronic Renal Failure).
- Coexisting neurological conditions (e.g., Cervical Radiculopathy,
- Polyneuropathy, Brachial Plexopathy).
- History of previous wrist surgery, trauma, or local corticosteroid injection within the last 6 months.
- Pregnancy or lactation.
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 |
|---|---|---|
| High-Resolution Ultrasonography and Electrophysiological EvaluationAlso: Ultrasonography, Nerve Conduction Studies (NCS)Participants underwent a high-resolution ultrasonographic examination using a high-frequency linear probe to measure the median nerve cross-sectional area (CSA) at the level of the pisiform bone. Subsequently, standardized electrophysiological evaluations (motor distal latency and sensory conduction velocity) were performed to classify CTS severity according to AAEM criteria. | Diagnostic test | CTS Patient Cohort |
Primary outcome
Median Nerve Cross-Sectional Area (CSA)
Time frame: At the time of enrollment (single measurement)
The cross-sectional area of the median nerve measured in square millimeters using high-resolution ultrasonography at the level of the pisiform bone. This measurement is the primary tool for morphological evaluation of the nerve.
2 secondary outcomes
Electrophysiological Severity Grading
Time frame: At the time of enrollment (single measurement)
Anthropometric Measurements (Absolute Body Weight and BMI)
Time frame: At the time of enrollment
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 3 Nov 2026.
- Background: PubMed 22806381Cartwright MS, Hobson-Webb LD, Boon AJ, Alter KE, Hunt CH, Flores VH, Werner RA, Shook SJ, Thomas TD, Primack SJ, Walker FO; American Association of Neuromuscular and Electrodiagnostic Medicine. Evidence-based guideline: neuromuscular ultrasound for the diagnosis of carpal tunnel syndrome. Muscle Nerve. 2012 Aug;46(2):287-93. doi: 10.1002/mus.23389.
- Background: PubMed 12058083Jablecki CK, Andary MT, Floeter MK, Miller RG, Quartly CA, Vennix MJ, Wilson JR; American Association of Electrodiagnostic Medicine; American Academy of Neurology; American Academy of Physical Medicine and Rehabilitation. Practice parameter: Electrodiagnostic studies in carpal tunnel syndrome [RETIRED]. Report of the American Association of Electrodiagnostic Medicine, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation. Neurology. 2002 Jun 11;58(11):1589-92. doi: 10.1212/wnl.58.11.1589. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers to ensure the confidentiality and privacy of the study participants in accordance with local ethical guidelines and national data protection laws (KVKK). The aggregated results and statistical analyses will be made available through the final publication. Specific requests for data may be evaluated by the Principal Investigator upon reasonable request and institutional approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Entrapment Neuropathies, run by Kayseri City Hospital 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 5 inclusion and 6 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 3 Nov 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 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 Cross-Sectional Area (CSA) (time frame: At the time of enrollment (single measurement)). 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 NCT07508397, which also lists 2 linked publications.
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 3 Nov 2026.