MR Elastography for the Herniated Intervertebral Disc

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Intervertebral Disc Herniation

Treatments: Other: Custom Magnetic Resonance Elastography Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03340545

STUDY00007840

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Healthy Individuals

Other group

Description:

Healthy individuals will be imaged for comparison purposes

Treatment:

Other: Custom Magnetic Resonance Elastography Device

Disc Herniation

Other group

Description:

Subjects diagnosed with Intervertebral Disc Herniation will be imaged to evaluate sensitivity of the proposed method.

Treatment:

Other: Custom Magnetic Resonance Elastography Device