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

NCT ID: NCT06926777

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-07-01

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. Undergo both an ultrasound and a NCS for comparison.

2. Visit the clinic for testing and evaluation as part of the study.

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.

Detailed Description

This study aims to compare ultrasound and NCS for diagnosing CTS by analyzing key median nerve parameters in both tests. CTS is a common condition caused by compression of the median nerve at the wrist, leading to symptoms such as numbness, tingling, and weakness in the hand. Accurate diagnosis is essential to ensure appropriate treatment.

Currently, NCS is considered the standard test for CTS diagnosis, measuring nerve function by assessing conduction velocity and latency. However, ultrasound has emerged as a potential alternative by providing structural imaging of the median nerve, including parameters like cross-sectional area (CSA), echogenicity, and flattening ratio.

The primary objective of this study is to determine whether ultrasound can be a reliable, non-invasive, and patient-friendly alternative to NCS for CTS diagnosis. By comparing nerve measurements obtained from both methods, researchers aim to evaluate their diagnostic accuracy, sensitivity, and specificity.

Participants with suspected CTS will undergo both ultrasound and NCS for comparison. Data will be analyzed to determine which test provides the most precise and clinically useful information. The findings of this study may help refine diagnostic protocols, potentially reducing the need for NCS in certain cases and offering a faster, more comfortable option for patients.

Conditions

Carpal Tunnel Syndrome (CTS); Nerve Conduction; Ultrasound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrasound Diagnostic Arm

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.

Group Type: OTHER

Nerve Conduction Study

Intervention Type: 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)

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.

Group Type: OTHER

Nerve Conduction Study

Intervention Type: 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.

Interventions

Nerve Conduction Study

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Adults aged 18 years or older.

2. Patients with clinical symptoms of CTS, including numbness, tingling, pain, or weakness in the hand.

3. Positive findings on clinical examination, such as Tinel's sign, Phalen's test, or Durkan's test.

4. Willingness to undergo both ultrasound and NCS for diagnostic evaluation.

Exclusion Criteria

1. Previous surgery for CTS in the affected hand.

2. History of peripheral neuropathy such as diabetic neuropathy

3. Other neuromuscular disorders affecting the upper limb such as cervical radiculopathy.

4. Pregnant women.

5. Severe comorbid conditions that may interfere with study participation.

6. Inability to provide informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Combined Military Hospital Kohat Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Syed Tameem Ul Hassan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Syed Tameem Ul Hassan, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Combined Military Hospital Kohat

Locations

Combined Military Hospital

Kohat, KPK, Pakistan

Countries

Pakistan

Central Contacts

Syed Tameem Ul Hassan, MBBS, FCPS

Role: CONTACT

drtameem2@gmail.com

00923368885877

Facility Contacts

Syed Tameem Ul Hassan, MBBS, FCPS

Role: primary

drtameem2@gmail.com

00923368885877

Other Identifiers

E-2005/A/114

Identifier Type: -

Identifier Source: org_study_id