Assessing the Comparability of 2D and 4D Ultrasound Measurements



Status:Not yet recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 80
Updated:8/4/2017
Start Date:January 2018
End Date:January 2019
Contact:Orthopedic Research Clinical Unit none
Email:ORCU@mayo.edu
Phone:(507) 284-1175

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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).

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.

Inclusion Criteria:

• Healthy Volunteers

Exclusion Criteria:

- Cervical radiculopathy

- Rheumatoid arthritis

- Osteoarthritis

- Flexor tendinitis

- Gout

- Hemodialysis

- Sarcoidosis

- Peripheral nerve disease

- Amyloidosis

- Traumatic injury - same arm
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Rochester, Minnesota 55905
Phone: 507-285-1175
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