Comparative Analysis of Median Nerve Parameters for Carpal Tunnel Syndrome (CTS) Diagnosis: Ultrasound Versus Nerve Conduction Studies (NCS)

NCT06926777 | Not Yet Recruiting DMC

• 1 other identifier: E-2005/A/114
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative Analysis of Median Nerve Parameters for Carpal Tunnel Syndrome (CTS) Diagnosis: Ultrasound vs. Nerve Conduction Study (NCS) This clinical study aims to determine whether ultrasound can be as practical as NCS in diagnosing CTS. It will also evaluate the accuracy of different median nerve measurements in both tests. The main questions it aims to answer are: Can ultrasound accurately detect CTS compared to NCS? Which median nerve measurements (such as size, speed, or function) are most useful for diagnosis? Researchers will compare ultrasound and NCS results in patients with CTS symptoms to determine which test is more reliable and patient-friendly. Participants will:

1. 1.Undergo both an ultrasound and a NCS for comparison.
2. 2.Visit the clinic for testing and evaluation as part of the study.
3. 3.Provide information about their symptoms and medical history related to CTS. This study aims to improve diagnosis accuracy and explore whether ultrasound could be a more comfortable and quicker alternative to NCS for detecting CTS.

Conditions

Carpal Tunnel Syndrome (CTS); Nerve Conduction; Ultrasound

Keywords

Carpal Tunnel Syndrome; Numbness; Tingling; Ultrasound; Nerve Conduction Study; Hand Weakness

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Ultrasound Compared to Nerve Conduction Study for Carpal Tunnel Syndrome

  Measuring the sensitivity, specificity, and overall accuracy of ultrasound in diagnosing CTS compared to NCS Parameters, including Median Nerve Latency, Amplitude, and Nerve Conduction Velocity

  Baseline

Study Arms (2)

Ultrasound Diagnostic Arm

OTHER

Participants in this arm will undergo ultrasound imaging of the median nerve at the wrist. Measurements such as CSA and flattening ratio will be recorded. The goal is to evaluate ultrasound's effectiveness in diagnosing CTS compared to NCS.

Diagnostic Test: Nerve Conduction Study

Nerve Conduction Study (NCS) Group (Diagnostic Arm)

OTHER

Participants in this arm will undergo an NCS to assess median nerve function. Parameters such as nerve conduction velocity, latency, and amplitude will be recorded. NCS findings will serve as the gold standard for comparison with ultrasound results.

Diagnostic Test: Nerve Conduction Study

Interventions

Nerve Conduction Study DIAGNOSTIC_TEST

This study involves two diagnostic interventions for evaluating CTS: Ultrasound Examination (Diagnostic Intervention) 1. A high-frequency ultrasound probe will be used to assess the median nerve at the wrist. 2. Parameters measured include cross-sectional area, flattening ratio, and echogenicity. The goal is to determine if ultrasound can accurately diagnose CTS compared to NCS. NCS (Diagnostic Intervention) 1. Surface electrodes will be placed on the skin to stimulate and record median nerve conduction. 2. Parameters such as latency, conduction velocity, and amplitude will be recorded. 3. NCS serves as the gold standard for diagnosing CTS and will be used for comparison with ultrasound results. Each participant will undergo both ultrasound and NCS, allowing researchers to compare their effectiveness in diagnosing CTS.

Nerve Conduction Study (NCS) Group (Diagnostic Arm); Ultrasound Diagnostic Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Patients with clinical symptoms of CTS, including numbness, tingling, pain, or weakness in the hand.
• Positive findings on clinical examination, such as Tinel's sign, Phalen's test, or Durkan's test.
• Willingness to undergo both ultrasound and NCS for diagnostic evaluation.

You may not qualify if:

• Previous surgery for CTS in the affected hand.
• History of peripheral neuropathy such as diabetic neuropathy
• Other neuromuscular disorders affecting the upper limb such as cervical radiculopathy.
• Pregnant women.
• Severe comorbid conditions that may interfere with study participation.
• Inability to provide informed consent.

Sponsors & Collaborators

• Combined Military Hospital Kohat Pakistan: lead

Study Sites (1)

Combined Military Hospital

Kohat, KPK, 26000, Pakistan

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Hypesthesia; Paresthesia

Interventions

Nerve Conduction Studies

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Syed Tameem Ul Hassan, MBBS, FCPS

  Combined Military Hospital Kohat

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syed Tameem Ul Hassan, MBBS, FCPS

CONTACT

00923368885877; drtameem2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: April 15, 2025
• Study Start: May 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the completion of study, data will be provided on demand and will be available for 6 months post completion.
• Access Criteria: Researchers will be given access. Data will be shared via email.

Locations

PA (1)