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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| injection based on 18F-Fluoride-PET/MRI | Experimental | 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. |
|
| injection based on clinical practise | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluoride-PET/MRI | Device | facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques. |
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| Measure | Description | Time Frame |
|---|---|---|
| pain reduction | reduction of pain after facet joint injection assessed by visual analogue scale (VAS) | VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection |
| Measure | Description | Time Frame |
|---|---|---|
| location of uptake in 18F-Fluoride-PET/MRI | location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist | 40 +/- 7 days post injection |
| quantity of uptake in 18F-Fluoride-PET/MRI | quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mazda Farshad, PD Dr. med. | Balgrist University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Balgrist | Zurich | Canton of Zurich | 8008 | Switzerland |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective randomised cohort study, partial blinded
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| facet injection | Procedure | 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 |
|
| pain assessment by VAS | Other | 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. |
|
| 40 +/- 7 days post injection |