An interventional study of FDG PET/MR examination. in Low Back Pain, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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.
10 patients with a clinical suspicion of at least 60% likelihood that low back pain arises from the lumbar facet joints will be recruited in clinic. The clinicians will rate the likelihood clinically of facet joint origin of pain and will assign a theoretical treatment plan based on initial clinical impression. They will indicate which facet joints, if any, they would refer for percutaneous treatment. The patients will undergo and FDG PET/MRI of the lumbar spine with IV gadolinium. The MRI signal change and enhancement of the lumbar facet joints will be graded by 2 radiologists blinded to the clinical data. The FDG PET scan activity of the facet joints will be graded by two nuclear medicine radiologists blinded to the clinical information. The clinicians will then be segmentally unblended to the imaging data as follows: 1. facet joints with high grade MRI signal change, 2. facet joints with any MRI signal change, 3. facet joints with high grade PET activity, and 4. facet joints with any PET activity. At each of these 4 steps, the clinician will indicate if this information would have the potential to alter clinical care (assuming that the imaging biomarker in question would be a surrogate for inflammation and pain) and if the information is concordant to the clinical impression. The clinical course of each patients will be followed for 1 year after undergoing the PET/MRI examination.
273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.
This study's enrollment of 10 is below the median of 63 across 219 interventional studies indexed under Arthralgia.
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Eligibility criteria - inclusion:
Eligibility criteria - exclusion:
All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study.
Device: FDG PET/MR examination.
All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
Facet Joint High Grade FDG Activity Concordance to Pain
Concordance of high grade FDG scores with clinical impression
Time frame: 2 years
Facet Joint All Grades of FDG Activity Concordance to Pain
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Time frame: 2 years
Facet Joint High Grade MRI Signal Change Concordance to Pain
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Time frame: 2 years
Facet Joint Any Grade of MRI Signal Change Concordance to Pain
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
Time frame: 2 years
Facet Joint High Grade FDG Activity Potential Effect on Management
Number/percentage of subjects for whom high grade FDG scores would change clinical management
Time frame: 2 years
Facet Joint All Grades of FDG Activity Potential Effect on Management
Number/percentage of subjects for whom any grade FDG scores would change clinical management
Time frame: 2 years
Facet Joint High Grade MRI Signal Change Potential Effect on Management
Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management
Time frame: 2 years
Facet Joint Any Grade MRI Signal Change Potential Effect on Management
Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management
Time frame: 2 years
| Milestone | PET/MR Recipients |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Concordance of high grade FDG scores with clinical impression
| concordance correlation coefficient | PET/MR Recipients |
|---|---|
| Facet Joint High Grade FDG Activity Concordance to Pain | 0.10 |
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
| sides (left or right) | PET/MR Recipients |
|---|---|
| Facet Joint All Grades of FDG Activity Concordance to Pain | 12 |
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
| sides (left or right) | PET/MR Recipients |
|---|---|
| Facet Joint High Grade MRI Signal Change Concordance to Pain | 12 |
Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression
| sides (Left or Right) | PET/MR Recipients |
|---|---|
| Facet Joint Any Grade of MRI Signal Change Concordance to Pain | 12 |
Number/percentage of subjects for whom high grade FDG scores would change clinical management
| Participants | PET/MR Recipients |
|---|---|
| Facet Joint High Grade FDG Activity Potential Effect on Management | 8 |
Number/percentage of subjects for whom any grade FDG scores would change clinical management
| Participants | PET/MR Recipients |
|---|---|
| Facet Joint All Grades of FDG Activity Potential Effect on Management | 8 |
Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management
| Participants | PET/MR Recipients |
|---|---|
| Facet Joint High Grade MRI Signal Change Potential Effect on Management | 8 |
Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management
| Participants | PET/MR Recipients |
|---|---|
| Facet Joint Any Grade MRI Signal Change Potential Effect on Management | 8 |
Collected over 1 year. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PET/MR Recipients | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | PET/MR Recipients |
|---|---|
| IV site swellingBlood and lymphatic system disorders | 1/10 |
| Age, Continuous(years) | PET/MR Recipients |
|---|---|
| Mean | 63 (50 to 79) |
| Sex: Female, Male(Participants) | PET/MR Recipients |
|---|---|
| Female | 7 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | PET/MR Recipients |
|---|
| Region of Enrollment(Participants) | PET/MR Recipients |
|---|---|
| United States | 10 |
| Number of patients with back pain(Participants) | PET/MR Recipients |
|---|---|
| Count of participants | 10 |
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