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

Primary Purpose

Arthropathy of Lumbar Facet, Pain, Back

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
18F-Fluoride-PET/MRI
facet injection
pain assessment by VAS
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arthropathy of Lumbar Facet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Clinic Balgrist

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

injection based on 18F-Fluoride-PET/MRI

injection based on clinical practise

Arm 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.

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.

Outcomes

Primary Outcome Measures

pain reduction
reduction of pain after facet joint injection assessed by visual analogue scale (VAS)

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2017
Last Updated
June 8, 2020
Sponsor
Balgrist University Hospital
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03317275
Brief Title
Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy
Official Title
Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy: A Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Lumbar Facet, Pain, Back

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised cohort study, partial blinded
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
injection based on 18F-Fluoride-PET/MRI
Arm Type
Experimental
Arm 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.
Arm Title
injection based on clinical practise
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
18F-Fluoride-PET/MRI
Intervention Description
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
Intervention Type
Procedure
Intervention Name(s)
facet injection
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
pain assessment by VAS
Intervention Description
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 Outcome Measure Information:
Title
pain reduction
Description
reduction of pain after facet joint injection assessed by visual analogue scale (VAS)
Time Frame
VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection
Secondary Outcome Measure Information:
Title
location of uptake in 18F-Fluoride-PET/MRI
Description
location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
Time Frame
40 +/- 7 days post injection
Title
quantity of uptake in 18F-Fluoride-PET/MRI
Description
quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
Time Frame
40 +/- 7 days post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazda Farshad, PD Dr. med.
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Balgrist
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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