MR Elastography for the Herniated Intervertebral Disc

NCT03340545 | Completed

• 1 other identifier: STUDY00007840
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Healthy Individuals

OTHER

Healthy individuals will be imaged for comparison purposes

Other: Custom Magnetic Resonance Elastography Device

Disc Herniation

OTHER

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

Other: Custom Magnetic Resonance Elastography Device

Interventions

Custom Magnetic Resonance Elastography Device OTHER

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

Disc Herniation; Healthy Individuals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Penn State University

State College, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel H Cortes, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: December 1, 2017
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: July 5, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)