Assessment of Carpal Tunnel Syndrome by Shearwave Elastography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FDA approved ultrasound system with shear wave elastography capability.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment Monitoring of Carpal Tunnel Syndrome Using Shear Wave Elastography: A Pilot in Vivo Study
Overview
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
- Device FDA 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 impro
Primary outcome measures
- Evaluate the treatment response by shear wave elastography (SWE) [Time frame: First 3 months]
Secondary outcome measures (1)
- 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 [Time frame: 3 to 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04804293 · 21-001106