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Clinical Trials/NCT04804293
NCT04804293
Enrolling By Invitation
Not Applicable

Treatment Monitoring of Carpal Tunnel Syndrome Using Shear Wave Elastography: A Pilot in Vivo Study

Mayo Clinic2 sites in 1 country20 target enrollmentMarch 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Mayo Clinic
Enrollment
20
Locations
2
Primary Endpoint
Evaluate the treatment response by shear wave elastography (SWE)
Status
Enrolling By Invitation
Last Updated
3 months ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
December 20, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Azra Alizad

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluate the treatment response by shear wave elastography (SWE)

Time Frame: First 3 months

Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength.

Secondary Outcomes

  • 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(3 to 6 months)

Study Sites (2)

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