Intervertebral Disc Herniation Clinical Trial
Official title:
Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc
Verified date | January 2019 |
Source | Penn State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 11, 2018 |
Est. primary completion date | December 11, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Penn State University | State College | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Penn State University | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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