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Completed

NCT Number: NCT03317275

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

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.

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Key information

Conditions

Arthropathy of Lumbar Facet Back Pain Neurologic Manifestations Pain Pain, Back Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

18F-Fluoride-PET/MRI

Device

facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.

facet injection

Procedure

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

Other

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.

Primary outcomes

  1. pain reduction

    Time frame: 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 outcomes

  1. location of uptake in 18F-Fluoride-PET/MRI

    Time frame: 40 +/- 7 days post injection

    location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist

  2. quantity of uptake in 18F-Fluoride-PET/MRI

    Time frame: 40 +/- 7 days post injection

    quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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