Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Recruiting · NCT06965452 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
Spinal angiography and embolization/ Embozene Microspheres
What this trial is about
This single-site, single-arm study evaluates the feasibility, safety, tolerability, and efficacy of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 18-85
- Confirmed diagnosis of spinal facet arthropathy on MRI OR CT
- Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks.
- Failed medical management of pain.
- Back pain persistent for at least 6 months
- Pain worse than at least 6/10 on a visual analog pain scale
- Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure.
- Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1).
- Modified Rankin Scale 0-2
Exclusion criteria
- \- Pregnancy
- History of prior spinal embolization at the target level.
- History of surgery/ stenting of the aorta at the level of embolization.
- Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)
- Creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min (except if patients is already on hemodialysis).
- Modified Rankin Scale \>2
- Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization.
Where it is running
1 location listed across 1 US state.
- North Shore University Hospital - Manhasset, New York, United States