Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2017
CompletedFirst Submitted
Initial submission to the registry
June 7, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2020
CompletedJune 9, 2020
June 1, 2020
2.9 years
June 7, 2017
June 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
location of uptake in 18F-Fluoride-PET/MRI
40 +/- 7 days post injection
quantity of uptake in 18F-Fluoride-PET/MRI
40 +/- 7 days post injection
Study Arms (2)
injection based on 18F-Fluoride-PET/MRI
EXPERIMENTALOne 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 COMPARATORThe 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.
Interventions
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
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
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Balgrist University Hospitallead
- University of Zurichcollaborator
Study Sites (1)
University Clinic Balgrist
Zurich, Canton of Zurich, 8008, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mazda Farshad, PD Dr. med.
Balgrist University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2017
First Posted
October 23, 2017
Study Start
May 26, 2017
Primary Completion
April 24, 2020
Study Completion
April 24, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06