Ultrasound with Shearwave Elastography for Carpal Tunnel Syndrome

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Prior surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new ultrasound method to check for stiffness and other issues in the wrists of patients, especially after treatments like surgery or injections. The ultrasound uses sound waves to take detailed pictures of the inside of the wrist.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for carpal tunnel syndrome?

Research shows that shear wave elastography (a type of ultrasound that measures tissue stiffness) can help diagnose carpal tunnel syndrome by detecting changes in the median nerve. This suggests it could be useful in assessing the condition and monitoring treatment response. ^{1 2 3 4 5}

Is ultrasound with shear wave elastography generally safe for humans?

The studies reviewed focus on the reliability and diagnostic performance of shear wave elastography (SWE) for carpal tunnel syndrome, but they do not report any safety concerns, suggesting that the technique is generally considered safe for use in humans. ^{2 3 5 6 7}

How is ultrasound with shear wave elastography different from other treatments for carpal tunnel syndrome?

This treatment is unique because it uses a non-invasive ultrasound technique to measure the stiffness and pressure in the carpal tunnel, helping to diagnose and assess the severity of carpal tunnel syndrome without the need for invasive procedures. ^{2 3 6 7 8}

Research Team

Azra Alizad, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I have pain in one of my wrists.

I am either male or female.

I am 18 years old or older.

Exclusion Criteria

People who are considered to be at higher risk or needing extra protection.

I am under 18 years old.

Experiencing symptoms on both sides of the body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Imaging

Participants undergo initial ultrasound imaging to assess wrist tissue stiffness before treatment

1 day

1 visit (in-person)

Treatment

Participants receive either surgical decompression or corticosteroid injection for carpal tunnel syndrome

1 day

1 visit (in-person)

Follow-up Imaging

Participants undergo follow-up ultrasound imaging to assess changes in wrist tissue stiffness

6 months

2 visits (in-person) at 3 and 6 months post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• FDA approved ultrasound system with shear wave elastography capability

Trial Overview 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.

Participant Groups

Group I: Operative treatment (surgical decompression) for carpal tunnel syndrome Experimental Treatment 1 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 syndrome Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Romania pubmed.ncbi.nlm.nih.gov

Carpal tunnel syndrome: elastosonographic strain ratio and cross-sectional area evaluation for the diagnosis and disease severity. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Diagnosis of Carpal Tunnel Syndrome using Shear Wave Elastography and High-frequency Ultrasound Imaging. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A non-invasive technique for evaluating carpal tunnel pressure with ultrasound vibro-elastography for patients with carpal tunnel syndrome: A pilot clinical study. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

The effectiveness of ultrasonography and ultrasonographic elastography in the diagnosis of carpal tunnel syndrome and evaluation of treatment response after steroid injection. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of the Diagnostic Performance of Strain Elastography and Shear Wave Elastography for the Diagnosis of Carpal Tunnel Syndrome. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the healthy median nerve elasticity: Feasibility and reliability of shear wave elastography. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Analysis of the thenar muscles with ultrasound shear wave elastography: Reliability and preliminary findings. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Shear wave elastography is a valuable tool for diagnosing and grading carpal tunnel syndrome. [2022]