Carpal Tunnel Syndrome
Conditions
Keywords
Shear Wave Elastography, Peripheral compression neuropathy, Neuropathy, Demyelination
Brief summary
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
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.
Interventions
DEVICEFDA approved ultrasound system with shear wave elastography capability
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the treatment response by shear wave elastography (SWE) | First 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 to 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAzra Alizad, MD
Mayo Clinic
Outcome results
None listed