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

Not Applicable

Completed

• Conditions: Arthropathy of Lumbar Facet; Pain, Back

• Registration Number: NCT03317275
• Lead Sponsor: Balgrist University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-26
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-23
• Primary Completion: 2020-04-24
• Study Completion: 2020-04-24
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
location of uptake in 18F-Fluoride-PET/MRI	40 +/- 7 days post injection	location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
quantity of uptake in 18F-Fluoride-PET/MRI	40 +/- 7 days post injection	quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist

Trial Locations

Locations (1)

University Clinic Balgrist; 🇨🇭 Zürich, Zurich, Switzerland