Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy
Study Details
Study Description
Brief Summary
Prior to the injection, the facet joints have to be defined according to standard radiological techniques (e.g. MRI and physical correlation). Patients are then sent to 18F-Fluoride-PET/MRI imaging, in order to localize facet joints with increased uptake. Facet joints to be injected are again defined according to the location(s) of highest uptake as demonstrated by 18F-Fluoride-PET/MRI.
The defined injection sites before and after PET/MRI are compared. In equal defined injection sites, patients are sent for infiltration as scheduled, otherwise patients are randomized into two groups.
One group will undergo facet injection(s) according to the 18F-Fluoride-PET/MRI result, with standard injections performed under CT-guidance by the radiology department of the study site. The control group will undergo facet injections blinded to the 18F-Fluoride-PET/MRI results, but based on current standard clinical practise (MRI and clinical correlation).
The patients are asked to complete a validated pain and function questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
The purpose of this study is to prospectively evaluate the value of 18F-Fluoride-PET/MRI imaging in patients with low back pain with evidence of painful facet joint arthropathy, which would potentially benefit from facet joint injections.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: injection based on 18F-Fluoride-PET/MRI One group will undergo facet injection(s) according to the 18F-Fluoride-PET/MRI result, with standard injections performed under CT-guidance. The Pain assessment by VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution. |
Device: 18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
Procedure: facet injection
facet joint local anesthetic and corticosteroid injection according to the 18F-Fluoride-PET/MRI result or based on current standard clinical practise (MRI and clinical correlation) respectively
Other: pain assessment by VAS
VAS questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
|
| Active Comparator: injection based on clinical practise The control group will undergo facet injections blinded to the 18F-Fluoride-PET/MRI results, but based on current standard clinical practise (MRI and clinical correlation). Pain assessment by VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution. |
Device: 18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
Procedure: facet injection
facet joint local anesthetic and corticosteroid injection according to the 18F-Fluoride-PET/MRI result or based on current standard clinical practise (MRI and clinical correlation) respectively
Other: pain assessment by VAS
VAS questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
|
Outcome Measures
Primary Outcome Measures
- pain reduction [VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection]
reduction of pain after facet joint injection assessed by visual analogue scale (VAS)
Secondary Outcome Measures
- location of uptake in 18F-Fluoride-PET/MRI [40 +/- 7 days post injection]
location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
- quantity of uptake in 18F-Fluoride-PET/MRI [40 +/- 7 days post injection]
quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients over 18 years old with low back pain who have failed conservative management in the primary care setting, namely, analgesia and physical therapy.
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Imaging evidence (e.g. MRI) of facet joint degeneration, such as facet hypertrophy, subchondral sclerosis, and joint space narrowing.
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Obtained informed consent
Exclusion Criteria:
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had undergone prior spinal surgery or prior facet joint injections or
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had other spinal abnormalities (benign or malignant tumors, congenital defects, isthmic spondylolisthesis) or
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are unable to tolerate PET/MRI imaging
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are pregnant or nursing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Clinic Balgrist | Zürich | Zurich | Switzerland | 8008 |
Sponsors and Collaborators
- Balgrist University Hospital
- University of Zurich
Investigators
- Principal Investigator: Mazda Farshad, PD Dr. med., Balgrist University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PET/MRI