N/A
N=10
FDG PET/MRI Evaluation of Facet Joint Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02921490 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Facet Joint High Grade FDG Activity Concordance to Pain — 0.10 concordance correlation coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FDG PET/MR examination. (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Facet Joint High Grade FDG Activity Concordance to Pain |
0.10 | — |
| PRIMARY Facet Joint All Grades of FDG Activity Concordance to Pain |
12 | — |
| PRIMARY Facet Joint High Grade MRI Signal Change Concordance to Pain |
12 | — |
| PRIMARY Facet Joint Any Grade of MRI Signal Change Concordance to Pain |
12 | — |
| PRIMARY Facet Joint High Grade FDG Activity Potential Effect on Management |
8 | — |
| PRIMARY Facet Joint All Grades of FDG Activity Potential Effect on Management |
8 | — |
| PRIMARY Facet Joint High Grade MRI Signal Change Potential Effect on Management |
8 | — |
| PRIMARY Facet Joint Any Grade MRI Signal Change Potential Effect on Management |
8 | — |
Summary
Chronic pain incurs over half a trillion dollars in lost productivity (healthcare, lost wages, etc) annually. The most common source is low back pain (LBP), often from facet joints. The clinical evaluation of facet joints is challenging and anatomic imaging findings of facet joint; degenerative change; correlate poorly with pain. Therefore, it is difficult to select appropriate candidate patients/facet joints to treat. Misguided percutaneous treatment can cost thousands of dollars per session and delay diagnoses. Very limited retrospective information suggests that high grade peri-facet MRI signal change correlates to the side of LBP. However, this has not fully characterized the imaging findings and has not correlated to expert clinical exam/percutaneous response, precluding robust and meaningful clinical impact. Minimal retrospective data concludes inflammatory changes can be identified on FDG-PET exams, but the evidence of correlation to patient pain is lacking. Limited DWI exists for inflammatory spondyloarthropathies and myopathies, but is also lacking.
This is an exploratory study investigating the utility of FDG PET activity and MRI signal change around facet joints in the clinical management of low back pain. This study will help determine if such imaging biomarkers could change clinical management. Additionally, this will provide data that will be vital to planning a larger prospective study evaluating the ability of imaging biomarkers to predict response to comparison medial branch blocks and RF ablation for treatment of facet joint pain.
Eligibility Criteria
Eligibility criteria - inclusion:
- Male and female patients over the age of 50-100 years with clinically suspected facetogenic low back pain.
- Patients 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.
- All patients will undergo a standardized clinical exam by an experienced physical medicine and rehabilitation clinician to confirm clinical suspicion of axial low back pain.
- Patients with either unilateral or bilateral axial low back pain may be enrolled.
Eligibility criteria - exclusion:
- 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
- Patients who are unable to lay quietly for 60 minutes of imaging
Data sourced from ClinicalTrials.gov (NCT02921490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.