Ultrasound with Shearwave Elastography for Carpal Tunnel Syndrome

N/A

Waitlist Available

Led By Azra Alizad, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Scheduled for corticosteroid injection or surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 to 6 months

Awards & highlights

Study Summary

This trial is testing a new ultrasound method to detect possible stiffness problems in the wrist(s). The purpose is to test the effectiveness of the new ultrasound method to check the nerve and surrounding tissue before and after treatment.

Who is the study for?

This trial is for adults over 18 with wrist pain from Carpal Tunnel Syndrome in one wrist, who are scheduled for a corticosteroid injection or surgery. It's not suitable for those under 18, anyone who has had previous wrist surgery, or individuals with symptoms in both wrists.Check my eligibility

What is being tested?

The study tests a new ultrasound technique using shear wave elastography to detect stiffness in the nerve and tissues of the affected wrist before and after treatment.See study design

What are the potential side effects?

Since this trial involves an ultrasound system which is non-invasive, there are minimal risks involved. However, some discomfort during the imaging process due to pressure on the sensitive area may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a corticosteroid injection or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the treatment response by shear wave elastography (SWE)

Secondary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Operative treatment (surgical decompression) for carpal tunnel syndromeExperimental Treatment1 Intervention

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.

Group II: Corticosteroid injection treatment for carpal tunnel syndromeExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met