"Ultrasound Measures and Clinical Outcomes in Healthy Individuals, Mild and Moderate Carpal Tunnel Syndrome Patients"

NCT07408596 | Completed FDA Device

• 1 other identifier: E-29624016-050.99-3483029
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

"This study aims to investigate ultrasonographic parameters of the median nerve in healthy individuals and patients with mild and moderate carpal tunnel syndrome (CTS). Specifically, investigator will assess the cross-sectional area (CSA) at the proximal carpal tunnel and the wrist/forearm ratio (WFR), and determine their diagnostic thresholds. İnvestigators will also evaluate correlations between these ultrasound measures and clinical and electrophysiological findings, including pain, symptom severity, functional status, and quality of life (Visual Analog Scale, Boston Carpal Tunnel Questionnaire, SF-36).

Conditions

Carpal Tunnel Syndrome (CTS); Median Nerve Entrapment; Electrophysiologic Study; Ultrasound; Ultrasound Diagnostics; Peripheral Nerve Disease; Peripheral Nerve Disorder; Entrapment Neuropathy, Carpal Tunnel; Entrapment Neuropathy

Keywords

Carpal tunnel syndrome; Ultrasound; nerve conduction study; median nerve entrapment; Sonographic examination; Cross sectional area(CSA); wrist to forearm ratio(WFR); Median nerve ultrasound; hand function; diagnostic imagining; pain assessment; Electrophysiologic examination; Boston Carpal Tunnel Questionnaire (BCTQ); Visual Analog Scale (VAS); Short Form(SF) -36; Hand ability; Mild-Moderate Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

• 1. Median Nerve Cross-Sectional Area (CSA)

  The cross-sectional area (mm²) of the median nerve will be measured using high-resolution ultrasonography at the carpal tunnel inlet (scaphoid-pisiform level). Measurements will be obtained in the transverse plane by tracing the inner border of the nerve. These values will be used to determine diagnostic cutoff thresholds differentiating healthy individuals from patients with mild or moderate carpal tunnel syndrome (CTS), as defined by clinical and electrodiagnostic findings. Unit of Measure: mm²

  17 July 2025- 30 December 2025

• 2. Wrist-to-Forearm Ratio (WFR)

  The wrist-to-forearm ratio will be calculated by dividing the median nerve CSA measured at the carpal tunnel inlet by the CSA measured approximately 12 cm proximal to the distal wrist crease. The result will be reported as a unitless ratio. This parameter will be analyzed to establish diagnostic threshold values distinguishing healthy participants from CTS patients. Unit of Measure: Unitless ratio

  17 July 2025-30 December 2025

Secondary Outcomes (3)

• 1. Pain Severity (Visual Analog Scale)

  17 July 2025- 30 December 2025

• 2. Symptom Severity and Functional Status (Boston Carpal Tunnel Questionnaire)

  17 July 2025- 30 December 2025

• 3. Quality of Life (Short Form-36)

  17 July 2025- 30 December 2025

Study Arms (3)

Healthy Participants

Healthy Participants: INCLUSION CRITERIA: Absence of any clinical symptoms related to CTS. Normal evaluation according to electrophysiological criteria for CTS. EXCLUSION CRITERIA: Participants will be excluded if they meet any of the following criteria: Age \< 18 or \> 60 years. Cognitive or mental incapacity preventing understanding or completion of questionnaires. Presence of any clinical symptoms potentially related to CTS based on established clinical criteria. Electrophysiological findings consistent with CTS, based on defined diagnostic thresholds.

Diagnostic Test: ultrasound

Mild CTS

Participants who receive a clinical CTS diagnosis based on the previously specified CTS clinical symptoms and findings, and who meet the EMG criteria outlined below, will be classified as having mild CTS. Clinical CTS Diagnosis: Symptoms must be present for at least three months and at least the presence of sensory symptoms (A) plus at least one of B, C, or D, together with at least one positive diagnostic test/sign, is required for clinical diagnosis. b.2) Electrophysiological Evaluation: Mild CTS: Median-ulnar sensory peak latency difference ≥ 0.4 ms in the 4th finger, and median sensory distal latency of the 2nd finger ≥ 2.8 ms, with conduction velocity \< 50 m/s. Sensory nerve action potential (SNAP) ≥ 12 μV. The inclusion and exclusion criteria required for mild and moderate CTS have been previously specified

Diagnostic Test: ultrasound

Moderate CTS

Participants who receive a clinical CTS diagnosis based on the previously specified CTS clinical symptoms and findings, and who meet the EMG criteria outlined below, will be classified as having moderate CTS. Clinical CTS Diagnosis: Symptoms must be present for at least three months and at least the presence of sensory symptoms (A) plus at least one of B, C, or D, together with at least one positive diagnostic test/sign, is required for clinical diagnosis. b.2) Electrophysiological Evaluation: Moderate CTS: Median distal motor latency of the 2nd finger between 4 ms and 5.5 ms, with conduction velocity \< 50 m/s. Compound muscle action potential (CMAP) ≥ 5 mV. The inclusion and exclusion criteria required for mild and moderate CTS have been previously specified

Diagnostic Test: ultrasound

Interventions

ultrasound DIAGNOSTIC_TEST

"We aim to determine whether carpal tunnel syndrome (CTS) can be accurately diagnosed using ultrasonographic parameters alone, and to what extent ultrasound-based parameters are consistent with electrodiagnostic (EMG) findings. Additionally, we seek to evaluate how the ultrasound parameters correlate with clinical outcomes, including functional status, quality of life, and pain severity."

Healthy Participants; Mild CTS; Moderate CTS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This cross-sectional analytical study is designed to include participants based on a power analysis and results from previous studies. To achieve 80% statistical power at a 95% confidence level, at least 68 participants are required; however, considering that a few participants may be excluded due to not meeting eligibility criteria, a total of 75 participants (150 hands) will be enrolled. The study will target individuals aged 18-60 years who present to the Physical Medicine and Rehabilitation outpatient clinic at İstanbul University, İstanbul Faculty of Medicine, Esnaf Hospital. Participants will include healthy individuals as well as patients diagnosed with mild to moderate carpal tunnel syndrome (CTS) based on clinical findings and electrophysiological evaluation. Before enrollment, all participants will be fully informed about the study, and written informed consent will be obtained. Demographic characteristics, including age, height, weight, will be recorded for all participants.

You may qualify if:

• Participants aged 18-60 years who meet the eligibility criteria as either healthy controls or patients with carpal tunnel syndrome (CTS) are eligible for the study.
• Healthy Participants:
• Absence of any clinical symptoms related to CTS.
• Normal evaluation according to electrophysiological criteria for CTS.
• Participants with CTS:
• Participants must have a diagnosis of mild or moderate CTS based on clinical findings and electrophysiological evaluation.
• b.1) Clinical Findings/Symptoms: b.1.1) Symptoms:
• (A)- Sensory symptoms in the 1st, 2nd, 3rd finger, or lateral half of the 4th finger, or in any combination of these.
• (B)- Symptom relief with hand-shaking or squeezing movements.
• (C)- Pain or paresthesia triggered by hand grip or forceful hand use.
• (D)- Nocturnal paresthesia causing the patient to wake from sleep.
• b.1.2) Diagnostic Tests/Signs:
• Tinel's sign
• Phalen test
• Reverse Phalen test

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul Unıversity, Istanbul Medicine Faculty, Esnaf Hospital

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Peripheral Nervous System Diseases; Neuritis; Charcot-Marie-Tooth Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mononeuropathies; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Demirhan Dıracoglu, Prof Dr

  Istanbul Unıversity Istanbul Medicine Faculty

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: February 13, 2026
• Study Start: July 25, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

TU (1)