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MR Elastography for the Herniated Intervertebral Disc

Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03340545
Enrollment
34
Registered
2017-11-13
Start date
2017-12-01
Completion date
2018-12-11
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervertebral Disc Herniation

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.

Interventions

OTHERCustom Magnetic Resonance Elastography Device

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

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Penn State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in mechanical properties of the herniated intervertebral disc1 weekIt is expected that MR Elastography can measure changes in mechanical properties of the herniated intervertebral disc.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026