MR Elastography for the Herniated Intervertebral Disc

Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc

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 Overview

• Status: Completed
• Conditions: Intervertebral Disc Herniation
• Intervention / Treatment: Other: Custom Magnetic Resonance Elastography Device

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • State College, Pennsylvania, United States, 16802
      • Penn State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Daniel H Cortes, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 11, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: STUDY00007840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No