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

Pain, Back Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317275
• Other study ID #: PET/MRI
• Status: Completed
• Phase: N/A
• Start date: May 26, 2017
• Est. completion date: April 24, 2020

Study information

• Verified date: June 2020
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Lumbar Facet
• Back Pain
• Joint Diseases
• Pain, Back

Intervention

Device:
• 18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.

Procedure:
• 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

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	University Clinic Balgrist	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Balgrist University Hospital	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	location of uptake in 18F-Fluoride-PET/MRI	location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist	40 +/- 7 days post injection
Secondary	quantity of uptake in 18F-Fluoride-PET/MRI	quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist	40 +/- 7 days post injection