Arthropathy of Lumbar FacetNCT03317275
Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy
A study testing 18F-Fluoride-PET/MRI, facet injection and pain assessment by VAS in people with Arthropathy of Lumbar Facet and Pain, Back, run by Balgrist University Hospital at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Lumbar Facet, Pain, Back
- What is being tested?
- 18F-Fluoride-PET/MRI, facet injection and pain assessment by VAS
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 May 2017to 24 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University Clinic Balgrist
Zurich, Canton of Zurich, 8008
About this study
Official title: Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy: A Prospective Cohort Study
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.
Read more
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.
- Conditions
- Arthropathy of Lumbar Facet, Pain, Back
- Being tested
- 18F-Fluoride-PET/MRI, facet injection, pain assessment by VAS
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoride-PET/MRIDevice
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
facet injectionProcedure or surgery
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 VASOther
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.
| Study group | Role | What they receive |
|---|---|---|
| injection based on 18F-Fluoride-PET/MRI | Experimental | 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. Receives: Device: 18F-Fluoride-PET/MRI; Procedure: facet injection; Other: pain assessment by VAS |
| injection based on clinical practise | Active comparator | 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. Receives: Device: 18F-Fluoride-PET/MRI; Procedure: facet injection; Other: pain assessment by VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain reduction
reduction of pain after facet joint injection assessed by visual analogue scale (VAS)
Measured: VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection
Secondary outcomes (2)
location of uptake in 18F-Fluoride-PET/MRI
location of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
Measured: 40 +/- 7 days post injection
quantity of uptake in 18F-Fluoride-PET/MRI
quantity of uptake in 18F-Fluoride-PET/MRI assessed by radiologist
Measured: 40 +/- 7 days post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start26 May 2017
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of Lumbar FacetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised cohort study, partial blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Mazda Farshad, PD Dr. med., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317275
- Sponsor's protocol ID
- PET/MRI
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03317275
- Acronym / sponsor ID
- PET/MRI
- Conditions
- Arthropathy of Lumbar Facet, Pain, Back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 26 May 2017 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective randomised cohort study, partial blinded
| Arm | Type | Receives |
|---|---|---|
| injection based on 18F-Fluoride-PET/MRI | Experimental | Device: 18F-Fluoride-PET/MRI, Procedure: facet injection, Other: pain assessment by VASOne 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. |
| injection based on clinical practise | Active comparator | Device: 18F-Fluoride-PET/MRI, Procedure: facet injection, Other: pain assessment by VASThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-Fluoride-PET/MRIfacet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques. | Device | injection based on 18F-Fluoride-PET/MRI, injection based on clinical practise |
| facet injectionfacet 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 | Procedure or surgery | injection based on 18F-Fluoride-PET/MRI, injection based on clinical practise |
| pain assessment by VASVAS 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. | Other | injection based on 18F-Fluoride-PET/MRI, injection based on clinical practise |
Primary outcome
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)
2 secondary outcomes
location of uptake in 18F-Fluoride-PET/MRI
Time frame: 40 +/- 7 days post injection
quantity of uptake in 18F-Fluoride-PET/MRI
Time frame: 40 +/- 7 days post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
Related trials for Arthropathy of Lumbar Facet
RecruitingObservational study
Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
Degenerative Arthropathy of Lumbar Spinal Facet Joint
Recruiting
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
Chronic Low-back Pain
Active, not recruitingPhase 2
Allogeneic BM-MSCs in Patients With Painful Lumbar Facet Arthropathy
Facet-Mediated Low Back Pain, Lumbar Facet Joint Osteoarthritis
Not yet recruitingObservational study
Association Between Trendelenburg Sign and Lumbar MRI Abnormalities
Facet Joint Arthropathy, Lower Back Pain
Not yet recruiting
Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery
Lumbar Fusion Surgery, Fusion of Joint
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazda Farshad, PD Dr. med. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-Fluoride-PET/MRI, facet injection and pain assessment by VAS in people with Arthropathy of Lumbar Facet and Pain, Back, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain reduction (time frame: VAS immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.