Assessing the Comparability of 2D and 4D Ultrasound Measurements

August 4, 2017 updated by: Peter C. Amadio, M.D., Mayo Clinic

Assessing the Comparability of 2D and 4D Ultrasound Measurements of Human Carpal Tunnel Synovium, Median Nerve and Tendon Displacement

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).

Study Overview

Status

Withdrawn

Conditions

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Healthy Volunteers

Exclusion Criteria:

  • Cervical radiculopathy
  • Rheumatoid arthritis
  • Osteoarthritis
  • Flexor tendinitis
  • Gout
  • Hemodialysis
  • Sarcoidosis
  • Peripheral nerve disease
  • Amyloidosis
  • Traumatic injury - same arm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4D Ultrasound
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.
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.
Active Comparator: 2D ultrasound
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
Time Frame: 1 year
the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
motion of the median nerve
Time Frame: 1 year
on cross sectional images, in mm from starting point, while the wrist is flexed
1 year
shape of median nerve
Time Frame: 1 year
on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Peter C. Amadio, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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