NCT07508397

Brief 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.

Trial Health

65
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Trial Health Score

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Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 24, 2026

Last Update Submit

March 30, 2026

Conditions

Keywords

UltrasonographyMedian NerveCross-Sectional AreaBody WeightBody Mass Index (BMI)ElectromyographyDiagnostic AccuracyPhysical and Rehabilitation Medicine

Outcome Measures

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.

    At the time of enrollment (single measurement)

Secondary Outcomes (2)

  • Electrophysiological Severity Grading

    At the time of enrollment (single measurement)

  • Anthropometric Measurements (Absolute Body Weight and BMI)

    At the time of enrollment

Study Arms (1)

CTS Patient Cohort

Patients aged 18-65 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

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)
CTS Patient Cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22806381BACKGROUND
  • 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.

    PMID: 12058083BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromeNerve Compression SyndromesBody Weight

Interventions

UltrasonographyNerve Conduction Studies

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalElectrodiagnosis

Central Study Contacts

Abdullah Goktug Yazar, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Abdullah Goktug Yazar

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 2, 2026

Study Start

April 1, 2026

Primary Completion

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.