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

B

Balgrist University Hospital

Status

Completed

Conditions

Pain, Back
Arthropathy of Lumbar Facet

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03317275
PET/MRI

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

injection based on 18F-Fluoride-PET/MRI
Experimental group
Description:
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.
Treatment:
Device: 18F-Fluoride-PET/MRI
Other: pain assessment by VAS
Procedure: facet injection
injection based on clinical practise
Active Comparator group
Description:
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.
Treatment:
Device: 18F-Fluoride-PET/MRI
Other: pain assessment by VAS
Procedure: facet injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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