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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

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.

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 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.

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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,386 Total Patients Enrolled
9 Trials studying Carpal Tunnel Syndrome
1,016 Patients Enrolled for Carpal Tunnel Syndrome
Azra Alizad, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
2,400 Total Patients Enrolled

Media Library

FDA approved ultrasound system with shear wave elastography capability (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT04804293 — N/A
Carpal Tunnel Syndrome Research Study Groups: Operative treatment (surgical decompression) for carpal tunnel syndrome, Corticosteroid injection treatment for carpal tunnel syndrome
Carpal Tunnel Syndrome Clinical Trial 2023: FDA approved ultrasound system with shear wave elastography capability Highlights & Side Effects. Trial Name: NCT04804293 — N/A
FDA approved ultrasound system with shear wave elastography capability (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804293 — N/A
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