A Study to Determine the Value of Combining PET and MRI Evaluations of Spinal Joint Pain in the Lower Back
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-001228
NCT ID: NCT02921490
Sponsor Protocol Number: 15-001228
About this study
The purpose of this study is to determine the usefulness of combining PET scan activity and MRI image biomarkers for the clinical management of spinal joint low back pain.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Male or female patient
- 50-100 years of age
- Has clinically suspected facetogenic low back pain
- Must be considered to have at least a 60% chance of having facet joints as the major source of low back pain based on overall clinical impression
- Will undergo a standardized clinical exam by an experienced physical medicine and rehabilitation clinician to confirm clinical suspicion of axial low back pain
- Either unilateral or bilateral axial low back pain
Exclusion Criteria
- Pregnancy
- Prior lumbar back surgery
- History of endovascular repair of abdominal aortic aneurysm or other postoperative change likely to introduce imaging artifact to the lumbar spine
- Suspected spine infection
- Known osseous metastatic or other osseous malignancy
- Facet joint percutaneous treatment within the past 2 months
- History of major lumbar spine trauma
- Inability to provide own consent
- Claustrophobia, cardiac pacemaker/wires in place, any absolute contraindication to MRI
- Impaired renal function indicated by a GFR less than 30
- Gadolinium allergy
- Highly radiosensitive medical conditions
- Unable to lay quietly for 60 minutes of imaging
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Vance Lehman, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available