Assessing the Comparability of 2D and 4D Ultrasound Measurements
Primary Purpose
Carpal Tunnel
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
4D Ultrasound
2D ultrasound
Sponsored by
About this trial
This is an interventional health services research trial for Carpal Tunnel
Eligibility Criteria
Inclusion Criteria:
• Healthy Volunteers
Exclusion Criteria:
- Cervical radiculopathy
- Rheumatoid arthritis
- Osteoarthritis
- Flexor tendinitis
- Gout
- Hemodialysis
- Sarcoidosis
- Peripheral nerve disease
- Amyloidosis
- Traumatic injury - same arm
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
4D Ultrasound
2D ultrasound
Arm Description
4D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. The same patients will be imaged with both 2D and 4D transducers.
2D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury.The same patients will be imaged with both 2D and 4D transducers.
Outcomes
Primary Outcome Measures
shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3
Secondary Outcome Measures
motion of the median nerve
on cross sectional images, in mm from starting point, while the wrist is flexed
shape of median nerve
on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02666911
Brief Title
Assessing the Comparability of 2D and 4D Ultrasound Measurements
Official Title
Assessing the Comparability of 2D and 4D Ultrasound Measurements of Human Carpal Tunnel Synovium, Median Nerve and Tendon Displacement
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Equipment to run the study was not available
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (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
Investigators will recruit 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. Images will be captured twice, first with the 2D transducer and then with the 4D transducer and compared to images captured with the new 4D transducer, using the same movement data analysis protocols. Investigators will also assess the inter and intrarater reliability of the 4D transducer images, by using two different sonographers, both trained in the technique, measuring the same blinded images on separate occasions, at least two weeks apart. The overall goal of this project is to assess the reliability, or reproducibility, of measurements in normal subjects using a novel 4D ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect motion between SSCT, median nerve and tendon motion for the evaluation and diagnosis of patients with disorders affecting the carpal tunnel, especially carpal tunnel syndrome (CTS).
Detailed Description
CTS can be diagnosed in many ways, but there are currently no non-invasive methods to assess the physiology within the carpal tunnel, which may help select treatment and predict treatment outcomes. The investigators have shown in preliminary work that differences in the motion of various structures within the carpal tunnel, including the median nerve, flexor tendons, and SSCT, vary in normal subjects and those with CTS. A clinical trial is already under way to assess conventional ultrasound imaging to predict outcomes of CTS treatments. In this study investigators wish to compare the current ultrasound methods, which involve moving two dimensional images, with a new technology which captures moving images in three dimensions (i.e., four dimensions, or 4D). If successful, a single 4D measurement could replace longitudinal and transverse 2D images, saving time and allowing better understanding of the relationship between displacements in both planes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4D Ultrasound
Arm Type
Experimental
Arm Description
4D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. The same patients will be imaged with both 2D and 4D transducers.
Arm Title
2D ultrasound
Arm Type
Active Comparator
Arm Description
2D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury.The same patients will be imaged with both 2D and 4D transducers.
Intervention Type
Procedure
Intervention Name(s)
4D Ultrasound
Intervention Description
Each subject will be imaged lying supine on imaging table with affected arm outstretched on Plexiglass board. An ultrasound scanner equipped with 15L8 linear array transducer will be set to depth of 20-25 mm with a 15MHz image acquisition frequency (for longitudinal and transverse imaging) and the same ultrasound machine equipped with 4D transducer will be used. Ultrasound evaluation will be performed by a sonographer trained in the pertinent image acquisition procedures. The image acquisition frame rate will be maintained at 70Hz, and the image compression will be set to low.
Intervention Type
Procedure
Intervention Name(s)
2D ultrasound
Intervention Description
Each subject will be imaged lying supine on imaging table with affected arm outstretched on Plexiglass board. An ultrasound scanner equipped with 15L8 linear array transducer will be set to depth of 20-25 mm with a 15MHz image acquisition frequency (for longitudinal and transverse imaging) and the same ultrasound machine equipped with 4D transducer will be used. Ultrasound evaluation will be performed by a sonographer trained in the pertinent image acquisition procedures. The image acquisition frame rate will be maintained at 70Hz, and the image compression will be set to low.
Primary Outcome Measure Information:
Title
shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
Description
the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3
Time Frame
1 year
Secondary Outcome Measure Information:
Title
motion of the median nerve
Description
on cross sectional images, in mm from starting point, while the wrist is flexed
Time Frame
1 year
Title
shape of median nerve
Description
on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Healthy Volunteers
Exclusion Criteria:
Cervical radiculopathy
Rheumatoid arthritis
Osteoarthritis
Flexor tendinitis
Gout
Hemodialysis
Sarcoidosis
Peripheral nerve disease
Amyloidosis
Traumatic injury - same arm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C. Amadio, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessing the Comparability of 2D and 4D Ultrasound Measurements
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