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CompletedNCT07508397CTS-US-WEIGHTUpdated Nov 3, 2026

Median Nerve Cross-Sectional Area and Body Weight in Carpal Tunnel Syndrome

An observational study in Carpal Tunnel Syndrome, Entrapment Neuropathies and Median Nerve Compression, sponsored by Kayseri City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Kayseri City Hospital · Observational

Updated Nov 3, 2026Now CompletedFirst site in Turkey (Türkiye)+6 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
119
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Carpal Tunnel Syndrome
  • Entrapment Neuropathies
  • Median Nerve Compression

Keywords

  • Ultrasonography
  • Median Nerve
  • Cross-Sectional Area
  • Body Weight
  • Body Mass Index (BMI)
  • Electromyography
  • Diagnostic Accuracy
  • Physical and Rehabilitation Medicine
03

In context

Carpal Tunnel Syndrome

587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.

This study's enrollment of 119 is above the median of 94 across 130 observational studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

Kayseri City Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
119 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Diagnostic Test: High-Resolution Ultrasonography and Electrophysiological Evaluation

Interventions

  • Diagnostic testHigh-Resolution Ultrasonography and Electrophysiological Evaluation

    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.

    Also known as: Ultrasonography, Nerve Conduction Studies (NCS)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the time of enrollment (single measurement)

Secondary outcomes

  1. 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.

    Time frame: At the time of enrollment (single measurement)

  2. 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.

    Time frame: At the time of enrollment

07

Study locations

1 site
  • Kayseri City Hospital, Department of Physical Medicine and Rehabilitation
    Kayseri, 38080, Turkey (Türkiye)
08

References and documents

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 22806381 ↗
  • Jablecki 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Nov 3, 2026
Sites
1 site added — first site in Turkey (Türkiye)
Show site
  • Kayseri City Hospital, Department of Physical Medicine and Rehabilitation · Kayseri, Turkey (Türkiye)
Nov 3, 2026
Start date
Apr 1, 2026→Apr 29, 2025 (actual)
Nov 3, 2026
Primary completion
Jul 1, 2026→Jun 11, 2026 (actual)
Nov 3, 2026
Study completion
Sep 1, 2026→Jun 11, 2026 (actual)
Nov 3, 2026
Enrollment
120 (estimated)→119 (actual)
Nov 3, 2026
Eligibility
Revised
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Not yet recruiting→Completed
    1 site added — first site in Turkey (Türkiye)
    Show site
    • Kayseri City Hospital, Department of Physical Medicine and Rehabilitation · Kayseri, Turkey (Türkiye)
    Start date Apr 1, 2026→Apr 29, 2025 (now actual)
    Primary completion Jul 1, 2026→Jun 11, 2026 (now actual)
    Study completion Sep 1, 2026→Jun 11, 2026 (now actual)
    Enrollment 120 (estimated)→119 (actual)
    Eligibility Revised
    + 3 other changes: verification date, arm descriptions and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07508397
Lead sponsor
Kayseri City Hospital
Responsible party
Abdullah Goktug Yazar (Dr. Abdullah Goktug Yazar, Kayseri City Hospital) — Principal investigator
First posted
Apr 2, 2026
Start date
Apr 29, 2025
Primary completion
Jun 11, 2026
Completion
Jun 11, 2026
Last update
Nov 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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