Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy
NCT ID: NCT03317275
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2017-05-26
2020-04-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
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
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.
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.
18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
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
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.
Interventions
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18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Balgrist University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mazda Farshad, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Balgrist University Hospital
Locations
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University Clinic Balgrist
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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PET/MRI
Identifier Type: -
Identifier Source: org_study_id
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