MR Elastography for the Herniated Intervertebral Disc

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc

Conditions
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Intervertebral Disc Herniation

Intervention / Treatment
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* Other: Custom Magnetic Resonance Elastography Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Individuals<br>Healthy individuals will be imaged for comparison purposes | Other: Custom Magnetic Resonance Elastography Device<br>* Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.<br>|
| Other: Disc Herniation<br>Subjects diagnosed with Intervertebral Disc Herniation will be imaged to evaluate sensitivity of the proposed method. | Other: Custom Magnetic Resonance Elastography Device<br>* Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week |