Ultrasound with Shearwave Elastography for Carpal Tunnel Syndrome

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound method to detect stiffness issues in the wrist for individuals with carpal tunnel syndrome. The study compares two treatments: surgery to relieve nerve pressure and corticosteroid injections. An FDA-approved ultrasound system with shear wave elastography capability will assess the tissue before and after these treatments. Individuals with wrist pain in only one hand who are already scheduled for either a corticosteroid injection or surgery may be suitable for this trial. Participants will have their wrists scanned before and several weeks after treatment to evaluate progress. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options for carpal tunnel syndrome.

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 prior data suggests that this ultrasound method is safe for detecting stiffness in wrists?

Research has shown that using ultrasound with shear wave elastography (SWE) is safe for diagnosing and monitoring carpal tunnel syndrome. This non-invasive method does not involve surgery or entering the body. Studies indicate that SWE is highly sensitive and provides detailed information about tissue stiffness without causing discomfort. No reports of negative effects have emerged from using this type of ultrasound.

Corticosteroid injections for carpal tunnel syndrome are also generally well-tolerated. These injections are common and have been used for many years to reduce inflammation and pain. While some individuals might experience temporary soreness or swelling at the injection site, serious side effects are rare.

Both treatments offer safe options for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how shear wave elastography (SWE) can provide detailed insight into tissue stiffness in patients with carpal tunnel syndrome. Unlike traditional diagnostic methods, SWE offers a non-invasive way to visualize changes in the wrist before and after treatments like surgical decompression or corticosteroid injections. This new technique might help doctors monitor recovery more precisely and tailor treatments for better outcomes. By potentially offering quicker and more accurate assessments, SWE could revolutionize how we understand and approach carpal tunnel syndrome.

What evidence suggests that this ultrasound method is effective for detecting stiffness in carpal tunnel syndrome?

Research has shown that a special type of ultrasound called shear wave elastography (SWE) holds promise for examining carpal tunnel syndrome (CTS). This trial will use SWE to assess tissue stiffness in participants receiving different treatments. For instance, participants in the corticosteroid injection arm will undergo SWE measurements to evaluate changes in stiffness six weeks after the injection, indicating treatment effectiveness. Participants undergoing operative treatment will have SWE assessments before surgery and at 3 and 6 months post-surgery. Additionally, combining SWE with other ultrasound methods has resulted in high accuracy for diagnosing CTS. Overall, SWE is becoming a valuable tool for both diagnosing CTS and tracking treatment progress. ^{1 2 5 6 7}

Who Is on the Research Team?

Azra Alizad, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 scheduled for a corticosteroid injection or surgery.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090190/

Diagnostic Accuracy of Integrating Ultrasound and Shear ... More recently, shear wave elastography (SWE), an ultrasound-based elasticity imaging technique, has demonstrated potential for evaluating CTS.

2. academicradiology.org academicradiology.org/article/S1076-6332(25)00208-9/fulltext

Ultrasound and Shear Wave Elastography From Diagnosis ... In this study, the use of US in CTS is very valuable in both guiding treatment and assessing response to treatment. There was a quantitative improvement in the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633224010328

The Efficacy of Shear Wave Elastography in Evaluating ... In conclusion, a significant decrease in SWE values was observed at the 6-week follow-up after US-guided local steroid injection in CTS patients. Therefore, SWE ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932468/

Enhanced diagnosis and severity assessment of carpal tunnel ... This study found that integrating SWE elasticity measurements with median nerve CSA achieved the highest diagnostic accuracy, with an AUC of ...

5. ejrnm.springeropen.com ejrnm.springeropen.com/articles/10.1186/s43055-024-01215-0

Role of conventional ultrasound and shear wave ... Shear wave at the wrist can significantly predict carpal tunnel syndrome with p value of 0.001 using a cutoff of 51 Kpa, sensitivity of 100%, ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jum.16450

Median Nerve Shear Wave Elastography Is Associated ... This study examines the associations between the median nerve (MN) shear wave elastography (SWE), the MN cross-sectional area (CSA), patient's symptoms, and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107663322030492X

Diagnosis of Carpal Tunnel Syndrome using Shear Wave ... The performance of ultrasound features from shear wave elastography (SWE) and high-frequency ultrasound imaging was evaluated independently and in combination ...