NCT07752797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

September 16, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

July 29, 2026

Last Update Submit

September 13, 2026

Conditions

Keywords

Median NerveUltrasonographyHand Grip Strength

Outcome Measures

Primary Outcomes (1)

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

    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).

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

Secondary Outcomes (4)

  • Boston Carpal Tunnel Questionnaire Symptom Severity Score

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

  • Boston Carpal Tunnel Questionnaire Functional Status Score

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

  • Hand Grip Strength Measured Using a Jamar Dynamometer (kg)

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

  • Pressure Pain Threshold Measured Using a Digital Algometer (kPa)

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

Study Arms (3)

Mild Carpal Tunnel Syndrome

Diagnostic Test: Ultrasonographic and Clinical Assessment

Moderate Carpal Tunnel Syndrome

Diagnostic Test: Ultrasonographic and Clinical Assessment

Severe Carpal Tunnel Syndrome

Diagnostic Test: Ultrasonographic and Clinical Assessment

Interventions

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.

Mild Carpal Tunnel SyndromeModerate Carpal Tunnel SyndromeSevere Carpal Tunnel Syndrome

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of adult patients (≥18 years) with clinically suspected and electrophysiologically confirmed carpal tunnel syndrome who are evaluated in the Physical Medicine and Rehabilitation outpatient clinic. Participants will be classified into mild, moderate, and severe groups according to electrophysiological severity.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Education and Research Hospital

Küçükçekmece, Istanbul, 34307, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 7, 2026

Study Start

June 1, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

September 16, 2026

Record last verified: 2026-09

Locations