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NCT Number: NCT07752797

Assessment of Ultrasound Findings, Nerve Test Results, and Hand Function in Patients With Carpal Tunnel Syndrome

Carpal tunnel syndrome is one of the most common conditions caused by compression of a nerve at the wrist. It can lead to numbness, tingling, pain, weakness, and difficulty performing daily activities. Although nerve conduction studies are widely used to confirm the diagnosis and assess disease severity, ultrasonography has become an increasingly important, non-invasive diagnostic tool. However, the relationship between ultrasound findings, nerve conduction study results, hand function, and symptom severity has not been fully clarified.

The purpose of this study is to investigate the relationship between the clinical severity of carpal tunnel syndrome and ultrasonographic, electrophysiological, and functional parameters. Participants with carpal tunnel syndrome will undergo ultrasonographic measurement of the median nerve, nerve conduction studies, hand grip strength assessment, pressure pain threshold measurement, and completion of the Boston Carpal Tunnel Questionnaire.

The investigators hypothesize that greater clinical severity will be associated with larger median nerve cross-sectional area, more severe electrophysiological abnormalities, reduced hand grip strength, lower pressure pain threshold, and poorer functional status. The findings of this study may improve the understanding of the relationship between structural, electrophysiological, and functional changes in carpal tunnel syndrome and contribute to clinical evaluation and patient management.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kanuni Sultan Suleyman Education and Research Hospital

Küçükçekmece, Istanbul, 34307, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hatice Zehra FERHATLAR

CONTACT

[email protected]

05367387869

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Clinical findings consistent with carpal tunnel syndrome
  • Carpal tunnel syndrome confirmed by electroneuromyography
  • Ability to understand and complete the study assessments
  • Provision of written informed consent

Exclusion criteria

  • Previous carpal tunnel release surgery
  • History of fracture, major trauma, or surgery involving the assessed wrist or hand
  • Cervical radiculopathy, brachial plexopathy, or other peripheral neuropathy affecting the upper extremity
  • Polyneuropathy
  • Inflammatory rheumatic disease or active infection involving the assessed upper extremity
  • Severe neurological or musculoskeletal disorder that may affect hand function
  • Inability to complete ultrasonographic, electrophysiological, functional, or questionnaire assessments

Treatment and study plan

Ultrasonographic and Clinical Assessment

Diagnostic Test

Participants will undergo a standardized diagnostic assessment including ultrasonographic measurement of the median nerve cross-sectional area at the carpal tunnel inlet, nerve conduction study evaluation, hand grip strength measurement using a Jamar dynamometer, pressure pain threshold assessment using a digital algometer, and completion of the Boston Carpal Tunnel Questionnaire. All assessments will be performed once during a single study visit. No therapeutic intervention will be administered.

Primary outcomes

  1. Median Nerve Cross-Sectional Area Measured by Ultrasonography (mm²)

    Time frame: Baseline (prior to study assessments, during the single study visit)

    The median nerve cross-sectional area will be measured by high-resolution ultrasonography at the carpal tunnel inlet (pisiform level). The mean of three measurements will be recorded in square millimeters (mm²).

Secondary outcomes

  1. Boston Carpal Tunnel Questionnaire Symptom Severity Score

    Time frame: Baseline (prior to study assessments, during the single study visit)

    Symptom severity will be assessed using the Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale. Scores range from 1 to 5, with higher scores indicating greater symptom severity.

  2. Boston Carpal Tunnel Questionnaire Functional Status Score

    Time frame: Baseline (prior to study assessments, during the single study visit)

    Functional status will be assessed using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-FSS). The questionnaire consists of 8 items evaluating difficulty in performing daily activities. Each item is scored from 1 (no difficulty) to 5 (cannot perform the activity), and the final score is calculated as the mean of all items. Higher scores indicate greater functional impairment.

  3. Hand Grip Strength Measured Using a Jamar Dynamometer (kg)

    Time frame: Baseline (prior to study assessments, during the single study visit)

    Maximum hand grip strength will be measured using a Jamar hydraulic hand dynamometer. The mean of three measurements will be recorded in kilograms (kg).

  4. Pressure Pain Threshold Measured Using a Digital Algometer (kPa)

    Time frame: Baseline (prior to study assessments, during the single study visit)

    Pressure pain threshold will be assessed using a digital pressure algometer. The mean of three measurements will be recorded in kPa

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Zehra FERHATLAR

CONTACT

[email protected]

+905367387869

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

Association of Clinical Severity With Ultrasonographic, Electrophysiological, and Functional Parameters in Patients With Carpal Tunnel Syndrome: A Cross-Sectional Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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