Comparative Analysis of Median Nerve Parameters for Carpal Tunnel Syndrome (CTS) Diagnosis: Ultrasound Versus Nerve Conduction Studies (NCS)
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:
- Undergo both an ultrasound and a NCS for comparison.
- Visit the clinic for testing and evaluation as part of the study.
- 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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Syed Tameem Ul Hassan, MBBS, FCPS
- Phone Number: 00923368885877
- Email: drtameem2@gmail.com
Study Locations
-
-
KPK
-
Kohat, KPK, Pakistan, 26000
- Combined Military Hospital
-
Contact:
- Syed Tameem Ul Hassan, MBBS, FCPS
- Phone Number: 00923368885877
- Email: drtameem2@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
This study involves two diagnostic interventions for evaluating CTS: Ultrasound Examination (Diagnostic Intervention)
The goal is to determine if ultrasound can accurately diagnose CTS compared to NCS. NCS (Diagnostic Intervention)
Each participant will undergo both ultrasound and NCS, allowing researchers to compare their effectiveness in diagnosing CTS. |
|
Other: 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.
|
This study involves two diagnostic interventions for evaluating CTS: Ultrasound Examination (Diagnostic Intervention)
The goal is to determine if ultrasound can accurately diagnose CTS compared to NCS. NCS (Diagnostic Intervention)
Each participant will undergo both ultrasound and NCS, allowing researchers to compare their effectiveness in diagnosing CTS. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Accuracy of Ultrasound Compared to Nerve Conduction Study for Carpal Tunnel Syndrome
Time Frame: Baseline
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Syed Tameem Ul Hassan, MBBS, FCPS, Combined Military Hospital Kohat
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-2005/A/114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Following IPD will be shared
- De-identified demographic data that is age, gender, relevant medical history.
- Ultrasound measurements of the median nerve such as CSA and flattening ratio.
- NCS results such as latency, conduction velocity and amplitude.
- Clinical assessment findings such as Tinel's sign, Phalen's test results.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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