NCT02666911

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

January 15, 2016

Last Update Submit

August 4, 2017

Conditions

Carpal Tunnel

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (2)

  • motion of the median nerve

    1 year

  • shape of median nerve

    1 year

Study Arms (2)

4D Ultrasound

EXPERIMENTAL

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

2D ultrasound

ACTIVE COMPARATOR

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

Interventions

4D UltrasoundPROCEDURE

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.

4D Ultrasound
2D ultrasoundPROCEDURE

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.

2D ultrasound

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Median Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Peter C. Amadio, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant - Hand Surgery

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 28, 2016

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 7, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share