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Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

Primary Purpose

Carpal Tunnel Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDA approved ultrasound system with shear wave elastography capability
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carpal Tunnel Syndrome focused on measuring Shear Wave Elastography, Peripheral compression neuropathy, Neuropathy, Demyelination

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Arizona
  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Operative treatment (surgical decompression) for carpal tunnel syndrome

Corticosteroid injection treatment for carpal tunnel syndrome

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Evaluate the treatment response by shear wave elastography (SWE)
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 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
Determine the severity and patient outcome scores in patients with symptoms of CTS and Correlate the symptom severity and functional status assessed by the Boston Carpal tunnel Questionnaire (CTQ)21 validated patient outcome scoring profile) in patients with diagnosis of carpal tunnel syndrome with SWE determined median nerve (MN) stiffness.

Full Information

First Posted
March 16, 2021
Last Updated
January 10, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04804293
Brief Title
Assessment of Carpal Tunnel Syndrome by Shearwave Elastography
Official Title
Treatment Monitoring of Carpal Tunnel Syndrome Using Shear Wave Elastography: A Pilot in Vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Shear Wave Elastography, Peripheral compression neuropathy, Neuropathy, Demyelination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Central hypothesis is that SWE provides quantitative information about the physical properties of the MN and surrounding tissue that help to identify carpal tunnel syndrome, its severity and response to treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operative treatment (surgical decompression) for carpal tunnel syndrome
Arm Type
Experimental
Arm Description
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.
Arm Title
Corticosteroid injection treatment for carpal tunnel syndrome
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FDA approved ultrasound system with shear wave elastography capability
Intervention Description
The investigators will acquire at least 4 acquisitions for each of 2 locations on the wrist. The objective is to correlate SWE measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX). 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.
Primary Outcome Measure Information:
Title
Evaluate the treatment response by shear wave elastography (SWE)
Description
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.
Time Frame
First 3 months
Secondary Outcome Measure Information:
Title
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
Description
Determine the severity and patient outcome scores in patients with symptoms of CTS and Correlate the symptom severity and functional status assessed by the Boston Carpal tunnel Questionnaire (CTQ)21 validated patient outcome scoring profile) in patients with diagnosis of carpal tunnel syndrome with SWE determined median nerve (MN) stiffness.
Time Frame
3 to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azra Alizad, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Assessment of Carpal Tunnel Syndrome by Shearwave Elastography

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