Clinical trial NCT02666911: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Carpal Tunnel
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
timeFrame: 1 year
Secondary outcomes:
measure: motion of the median nerve
timeFrame: 1 year
measure: shape of median nerve
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Peter C. Amadio, M.D.
role: PRINCIPAL_INVESTIGATOR
References: