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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/MR recipients | Experimental | All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET/MR examination. | Device | All recruited patients will undergo an FDG PET examination focused on the lumbar spine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Facet Joint High Grade FDG Activity Concordance to Pain | Concordance of high grade FDG scores with clinical impression | 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 | 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 | 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 | 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 | 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 | 2 years |
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Eligibility criteria - inclusion:
Eligibility criteria - exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Vance T Lehman | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PET/MR Recipients | All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PET/MR Recipients | All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Facet Joint High Grade FDG Activity Concordance to Pain | Concordance of high grade FDG scores with clinical impression | Posted | Number | concordance correlation coefficient | 2 years |
|
|
1 year
No serious adverse events have been reported. No one is suspected to have a serious adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PET/MR Recipients | All recruited patients will undergo FDG PET/MR of the lumbar spine as the single arm of the study. FDG PET/MR examination.: All recruited patients will undergo an FDG PET examination focused on the lumbar spine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV site swelling | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vance Lehman | Mayo Clinic | 1-507-284-2511 | lehman.vance@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2017 | Jan 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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 |
| 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 | 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of patients with back pain | Count of Participants | Participants |
|
|
| Primary | 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 | The measure is best reported in sides, which is 2 sides per patient. 10 patients with 20 sides. | Posted | Number | sides (left or right) | 2 years | sides (left or right) | sides (left or right) |
|
|
|
| Primary | 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 | Two sides for each patient, for a total of 20 sides | Posted | Number | sides (left or right) | 2 years |
|
|
|
| Primary | 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 | two sides for each patient, for a total of 20 sides | Posted | Number | sides (Left or Right) | 2 years |
|
|
|
| Primary | Facet Joint High Grade FDG Activity Potential Effect on Management | Number/percentage of subjects for whom high grade FDG scores would change clinical management | Posted | Count of Participants | Participants | 2 years |
|
|
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| Primary | 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 | Posted | Count of Participants | Participants | 2 years |
|
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| Primary | 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 | Posted | Count of Participants | Participants | 2 years |
|
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|
| Primary | 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 | Posted | Count of Participants | Participants | 2 years |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |