MR Elastography for the Herniated Intervertebral Disc

Not Applicable

Completed

• Conditions: Intervertebral Disc Herniation
• Interventions: Other: Custom Magnetic Resonance Elastography Device

• Registration Number: NCT03340545
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-13
• Study Start: 2017-12-01
• Primary Completion: 2018-12-11
• Study Completion: 2018-12-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disc Herniation	Custom Magnetic Resonance Elastography Device	Subjects diagnosed with Intervertebral Disc Herniation will be imaged to evaluate sensitivity of the proposed method.
Healthy Individuals	Custom Magnetic Resonance Elastography Device	Healthy individuals will be imaged for comparison purposes

Primary Outcome Measures

Name	Time	Method
Changes in mechanical properties of the herniated intervertebral disc	1 week	It is expected that MR Elastography can measure changes in mechanical properties of the herniated intervertebral disc.

Trial Locations

Locations (1)

Penn State University; 🇺🇸 State College, Pennsylvania, United States