What side effects are associated with this type of intervention?

Common treatments for Carpal Tunnel Syndrome include wrist splinting, corticosteroid injections, and surgical intervention. For non-invasive imaging methods like ultrasound, which is used to detect tissue stiffness, the side effects are minimal and primarily involve temporary discomfort or mild skin irritation at the site of the ultrasound probe. In contrast, corticosteroid injections can cause side effects such as pain at the injection site, temporary increase in blood sugar levels, and, rarely, infection. Surgical treatments, while effective, carry risks such as infection, nerve damage, and prolonged recovery time.

What prior FDA approvals exist?

The context does not provide specific details on FDA approvals or related drugs for Carpal Tunnel Syndrome. However, common treatments for CTS typically include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and physical therapy. Surgical options are also available for severe cases. The study mentioned focuses on using a new ultrasound method to detect tissue stiffness, which is an emerging diagnostic tool rather than a treatment.

What other types of research exist?

Promising, novel alternatives to ultrasound methods for detecting tissue stiffness in Carpal Tunnel Syndrome patients include MRI, which has been effective in early rheumatoid arthritis, and Doppler sonography, which is used for imaging hand and finger joints. These methods could provide detailed imaging and assessment of the median nerve and surrounding tissues in CTS patients.

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Diagnostic Device

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

Must not have

Individuals less than 18 years of age

Prior surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 to 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have had surgery before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the treatment response by shear wave elastography (SWE)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Carpal Tunnel Syndrome (CTS) aim to reduce pressure on the median nerve within the carpal tunnel. Splinting keeps the wrist in a neutral position to minimize nerve compression, while corticosteroid injections reduce inflammation and swelling, thereby decreasing pressure on the nerve. Surgical release involves cutting the transverse carpal ligament to enlarge the carpal tunnel and relieve nerve compression. The new ultrasound method being studied focuses on detecting tissue stiffness, which is crucial for diagnosing and monitoring the effectiveness of these treatments. By identifying areas of increased stiffness, healthcare providers can better tailor interventions to reduce nerve compression and improve patient outcomes.