Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT04804293
Status
Enrolling By Invitation

Conditions

  • Carpal Tunnel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • FDA approved ultrasound system with shear wave elastography capability — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 15, 2021
Status verified
Jan 2026
Primary completion
Dec 20, 2026
Completion
Dec 20, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Operative treatment (surgical decompression) for carpal tunnel syndrome
    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.
  • Experimental: Corticosteroid injection treatment for carpal tunnel syndrome
    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.

Primary Outcome Measure

Evaluate the treatment response by shear wave elastography (SWE) [ Time Frame: First 3 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in RochesterRochesterMinnesota55905-

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Mayo Clinic in Arizona· Scottsdale, AZMayo Clinic in Rochester· Rochester, MN

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