Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

Study Overview
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Brief Summary
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This study is being done to test a new ultrasound method to detect possible stiffness problems within wrist(s). The purpose of this research is to the test the effectiveness of a new ultrasound method to check the nerve and surrounding tissue in both wrist of patient volunteers before and after treatment.

Detailed Description
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The ultrasound system is FDA approved. The risks associated with this research study are not beyond the normal risk of conventional ultrasound and should not cause you any discomfort. Ultrasound at the intensity levels and duration used in this study has not been shown to present risk to humans. The investigators will conduct the SWE study on the set time point when the patient returns for follow-up after the therapy (surgical decompression or corticosteroid injection). A set of pictures will be taken of patients wrists by the FDA approved ultrasound system. This system uses a special type of ultrasound for imaging your wrists. The ultrasound study will be repeated after 3 and 6 months after the treatments.

Official Title
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Treatment Monitoring of Carpal Tunnel Syndrome Using Shear Wave Elastography: A Pilot in Vivo Study

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: FDA approved ultrasound system with shear wave elastography capability


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female volunteers. Age ≥ 18 years old. Having unilateral symptom of wrist pain Scheduled for corticosteroid injection or surgery Exclusion Criteria: Individuals less than 18 years of age. Prior surgery. People considered in vulnerable populations. Having bilateral symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Central hypothesis is that SWE provides quantitative information about the physical properties of the MN and surrounding tissue that help to identify carpal tunnel syndrome, its severity and response to treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Operative treatment (surgical decompression) for carpal tunnel syndrome<br>Shear wave elastography (SWE) will be used to assess the stiffness of tissue. Patients will be revaluated at 3 and 6 months post-operatively. Patient will sit done in a chair. The investigators will scan the wrist area of both arms to acquire SWE map. This imaging will be done before the treatment. We will repeat the imaging study at 3 and 6 months after the treatment. Each ultrasound imaging session will take about less than 10 min. The investigators do not expect any discomfort during the imaging. | Device: FDA approved ultrasound system with shear wave elastography capability<br>* The investigators will acquire at least 4 acquisitions for each of 2 locations on the wrist. The objective is to correlate SWE measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX). Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength.<br>|
| Experimental: Corticosteroid injection treatment for carpal tunnel syndrome<br>Shear wave elastography (SWE) will be used to assess the stiffness of tissue. Patients will be revaluated after 6 weeks following corticosteroid injection. Patient will sit done in a chair. The investigators will scan the wrist area of both arms to acquire SWE map. The investigators do not expect any discomfort during the imaging. | Device: FDA approved ultrasound system with shear wave elastography capability<br>* The investigators will acquire at least 4 acquisitions for each of 2 locations on the wrist. The objective is to correlate SWE measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX). Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the treatment response by shear wave elastography (SWE) | Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength. | First 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate shear wave elastography (SWE) measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX) elasticity | Determine the severity and patient outcome scores in patients with symptoms of CTS and Correlate the symptom severity and functional status assessed by the Boston Carpal tunnel Questionnaire (CTQ)21 validated patient outcome scoring profile) in patients with diagnosis of carpal tunnel syndrome with SWE determined median nerve (MN) stiffness. | 3 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shear Wave Elastography, Peripheral compression neuropathy, Neuropathy, Demyelination