MR Elastography for 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.

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Key information

Conditions

Intervertebral Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

State College, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Custom Magnetic Resonance Elastography Device

Other

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

Primary outcomes

Changes in mechanical properties of the herniated intervertebral disc

Time frame: 1 week

It is expected that MR Elastography can measure changes in mechanical properties of the herniated intervertebral disc.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Official study title

Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Nov 13, 2017
Registry last updated: Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed