Arthropathy of Lumbar Facet, Pain, Back
Conditions
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.
Interventions
DEVICE18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
PROCEDUREfacet 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
OTHERpain 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.
Sponsors
University of Zurich
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Prospective randomised cohort study, partial blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients over 18 years old with low back pain who have failed conservative management in the primary care setting, namely, analgesia and physical therapy. 2. Imaging evidence (e.g. MRI) of facet joint degeneration, such as facet hypertrophy, subchondral sclerosis, and joint space narrowing. 3. Obtained informed consent
Exclusion criteria
1. had undergone prior spinal surgery or prior facet joint injections or 2. had other spinal abnormalities (benign or malignant tumors, congenital defects, isthmic spondylolisthesis) or 3. are unable to tolerate PET/MRI imaging 4. are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| quantity of uptake in 18F-Fluoride-PET/MRI | 40 +/- 7 days post injection | quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist |
| location of uptake in 18F-Fluoride-PET/MRI | 40 +/- 7 days post injection | location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist |
Countries
Switzerland
Outcome results
None listed