Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Penn State University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Changes in mechanical properties of the herniated intervertebral disc
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy controls must be generally healthy individuals in the age range of 18-
- •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
Arms & Interventions
Healthy Individuals
Healthy individuals will be imaged for comparison purposes
Intervention: Custom Magnetic Resonance Elastography Device (Other)
Disc Herniation
Subjects diagnosed with Intervertebral Disc Herniation will be imaged to evaluate sensitivity of the proposed method.
Intervention: Custom Magnetic Resonance Elastography Device (Other)
Outcomes
Primary Outcomes
Changes in mechanical properties of the herniated intervertebral disc
Time Frame: 1 week
It is expected that MR Elastography can measure changes in mechanical properties of the herniated intervertebral disc.
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Cortes
Assistant Professor
Penn State University