Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy: A Prospective Cohort Study

Conditions
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Pain, Back, Arthropathy of Lumbar Facet

Intervention / Treatment
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* Device: 18F-Fluoride-PET/MRI
* Procedure: facet injection
* Other: pain assessment by VAS


Participation Criteria
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Eligibility Criteria
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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. Imaging evidence (e.g. MRI) of facet joint degeneration, such as facet hypertrophy, subchondral sclerosis, and joint space narrowing. Obtained informed consent Exclusion Criteria: had undergone prior spinal surgery or prior facet joint injections or had other spinal abnormalities (benign or malignant tumors, congenital defects, isthmic spondylolisthesis) or are unable to tolerate PET/MRI imaging are pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomised cohort study, partial blinded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: injection based on 18F-Fluoride-PET/MRI<br>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<br>* facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.<br>Procedure: facet injection<br>* 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<br>Other: pain assessment by VAS<br>* 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.<br>|
| Active Comparator: injection based on clinical practise<br>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<br>* facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.<br>Procedure: facet injection<br>* 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<br>Other: pain assessment by VAS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 40 +/- 7 days post injection |