MR Elastography for the Herniated Intervertebral Disc

Intervertebral Disc Herniation Clinical Trial

Official title:

Evaluating Changes in Mechanical Properties in the Herniated Intervertebral Disc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340545
• Other study ID #: STUDY00007840
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 11, 2018

Study information

• Verified date: January 2019
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Intervertebral Disc Herniation

Intervention

Other:
• Custom Magnetic Resonance Elastography Device
Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.

Locations

Country	Name	City	State
United States	Penn State University	State College	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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