MR Elastography for the Herniated Intervertebral Disc

NCT ID: NCT03340545

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-12-11

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.

Conditions

Intervertebral Disc Herniation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Individuals

Healthy individuals will be imaged for comparison purposes

Group Type: OTHER

Custom Magnetic Resonance Elastography Device

Intervention Type: OTHER

Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.

Disc Herniation

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

Group Type: OTHER

Custom Magnetic Resonance Elastography Device

Intervention Type: OTHER

Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.

Interventions

Custom Magnetic Resonance Elastography Device

Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Daniel Cortes

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel H Cortes, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State University

State College, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00007840

Identifier Type: -

Identifier Source: org_study_id