Back to resultsMR Elastography for the Herniated Intervertebral Disc
Primary Purpose
Intervertebral Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom Magnetic Resonance Elastography Device
Sponsored by
About this trial
This is an interventional diagnostic trial for Intervertebral Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- Healthy controls must be generally healthy individuals in the age range of 18-65.
- Patients, 18 to 65 years old, who have undergone or will undergo MRI as part of the diagnosis of back pain and are diagnosed with one or more herniated discs in the lumbar spine (aka, disc rupture).
Exclusion Criteria:
- Participants with a history of neurological injury or disease will be excluded.
- Participants with contraindications to MRI scanning will be excluded (e.g., electric/mechanical implant, device such as a pacemaker).
- Participants who are claustrophobic will be excluded.
- Participants who are >250 lbs will be excluded (due to weight and physical constraints of - the scanner, i.e., 55 cm bore).
- Those unable to consent, pregnant women, children, and prisoners will be excluded.
- People under the age of 18 will be excluded as well.
- Individuals who do not understand English (written or spoken) will be excluded
Sites / Locations
- Penn State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Healthy Individuals
Disc Herniation
Arm Description
Healthy individuals will be imaged for comparison purposes
Subjects diagnosed with Intervertebral Disc Herniation will be imaged to evaluate sensitivity of the proposed method.
Outcomes
Primary Outcome Measures
Changes in mechanical properties of the herniated intervertebral disc
It is expected that MR Elastography can measure changes in mechanical properties of the herniated intervertebral disc.
Secondary Outcome Measures
Full Information
NCT ID
NCT03340545
First Posted
November 8, 2017
Last Updated
July 2, 2019
Sponsor
Penn State University
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03340545
Brief Title
MR Elastography for the Herniated Intervertebral Disc
Official Title
Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Low back pain is a major cause of disability, especially in the working-age population. A total of 149 million working days are lost every year as a consequence of back pain. Intervertebral disc (IVD) degeneration is thought to play a major role in chronic back and neck pain. Decades of bench-top research in tissue mechanics have shown clear relationships between changes in mechanical properties and abnormal changes IVD structure and composition. Our overall hypothesis is that measurements of IVD mechanical properties can provide valuable information about its structure and composition for early diagnosis of degeneration, quantification of degeneration progress, and evaluation of treatment strategies. Magnetic Resonance Elastography (MRE) is an imaging method to quantify mechanical properties from soft tissues. The objectives of this study are to evaluating repeatability and collecting base line data from healthy individuals; and to apply MRE to patients with disc herniation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Herniation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Individuals
Arm Type
Other
Arm Description
Healthy individuals will be imaged for comparison purposes
Arm Title
Disc Herniation
Arm Type
Other
Arm Description
Subjects diagnosed with Intervertebral Disc Herniation will be imaged to evaluate sensitivity of the proposed method.
Intervention Type
Other
Intervention Name(s)
Custom Magnetic Resonance Elastography Device
Intervention Description
Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.
Primary Outcome Measure Information:
Title
Changes in mechanical properties of the herniated intervertebral disc
Description
It is expected that MR Elastography can measure changes in mechanical properties of the herniated intervertebral disc.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy controls must be generally healthy individuals in the age range of 18-65.
Patients, 18 to 65 years old, who have undergone or will undergo MRI as part of the diagnosis of back pain and are diagnosed with one or more herniated discs in the lumbar spine (aka, disc rupture).
Exclusion Criteria:
Participants with a history of neurological injury or disease will be excluded.
Participants with contraindications to MRI scanning will be excluded (e.g., electric/mechanical implant, device such as a pacemaker).
Participants who are claustrophobic will be excluded.
Participants who are >250 lbs will be excluded (due to weight and physical constraints of - the scanner, i.e., 55 cm bore).
Those unable to consent, pregnant women, children, and prisoners will be excluded.
People under the age of 18 will be excluded as well.
Individuals who do not understand English (written or spoken) will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel H Cortes, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MR Elastography for the Herniated Intervertebral Disc
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