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Clinical Trials/NCT03340545
NCT03340545
Completed
Not Applicable

Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc

Penn State University1 site in 1 country34 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intervertebral Disc Herniation
Sponsor
Penn State University
Enrollment
34
Locations
1
Primary Endpoint
Changes in mechanical properties of the herniated intervertebral disc
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
December 11, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Cortes

Assistant Professor

Penn State University

Eligibility Criteria

Inclusion Criteria

  • Healthy controls must be generally healthy individuals in the age range of 18-
  • 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

Outcomes

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.

Study Sites (1)

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