ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing the Comparability of 2D and 4D Ultrasound Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02666911
Recruitment Status : Withdrawn (Equipment to run the study was not available)
First Posted : January 28, 2016
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Peter C. Amadio, M.D., Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Carpal Tunnel Procedure: 4D Ultrasound Procedure: 2D ultrasound Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing the Comparability of 2D and 4D Ultrasound Measurements of Human Carpal Tunnel Synovium, Median Nerve and Tendon Displacement
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


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.
Procedure: 4D Ultrasound
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.
Procedure: 2D ultrasound
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. motion of the median nerve [ Time Frame: 1 year ]
    on cross sectional images, in mm from starting point, while the wrist is flexed

  2. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666911


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Peter C. Amadio, M.D. Mayo Clinic

Responsible Party: Peter C. Amadio, M.D., Consultant - Hand Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02666911     History of Changes
Other Study ID Numbers: 15-008487
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries