Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

Mayo Clinic

Status: Invitation-only

Conditions: Carpal Tunnel Syndrome

Treatments: Device: FDA approved ultrasound system with shear wave elastography capability

Study type: Interventional

Funder types: Other

Identifiers

NCT04804293

21-001106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Operative treatment (surgical decompression) for carpal tunnel syndrome

Experimental group

Description:

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.

Treatment:

Device: FDA approved ultrasound system with shear wave elastography capability

Corticosteroid injection treatment for carpal tunnel syndrome

Experimental group

Description:

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.

Treatment:

Device: FDA approved ultrasound system with shear wave elastography capability