Actively Recruiting
Trans Arterial Embolization for Facet Arthropathy
Led by Northwell Health · Updated on 2025-08-19
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, tolerability, and effectiveness of trans-arterial embolization (TAE) using Embozene microparticles to treat facetogenic pain caused by facet arthropathy, a type of osteoarthritis affecting the facet joints in the lumbar spine. Facet arthritis is common with age and can cause significant pain and disability. This single-site, single-arm study aims to explore this treatment option as an alternative to current medical management, injections, neurolysis, or surgery. Participants will receive trans-arterial embolization of the dorsal branches of the segmental arteries supplying the spine's bony elements using Embozene microspheres. The procedure will be done once at North Shore University Hospital, followed by a 5-hour recovery monitoring period before discharge. This study focuses on treating facetogenic low back pain at up to two spinal levels in the lumbar and sacral regions. During the study, participants will undergo spinal angiography and embolization, with safety monitored through the number of serious adverse events within one year after the procedure. Pain improvement will be measured using the Visual Analog Scale (VAS), and disability will be assessed by the Oswestry Low Back Pain Disability Questionnaire after one year. The study will also track recovery and tolerability over this time, with total participant involvement lasting at least one year.
CONDITIONS
Brief Title
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Confirmed diagnosis of spinal facet arthropathy on MRI or CT
- Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks
- Persistent back pain for at least 6 months
- Pain rated worse than 6 out of 10 on a visual analog pain scale
- Failed medical management of pain
- Failed at least one of either intra-articular injections of steroids/anesthetics or neuro-ablative procedure
- Maximum of two spinal levels affected by facetogenic pain in the lumbar and sacral spine
- Modified Rankin Scale score between 0 and 2
You will not qualify if you...
- Pregnancy
- History of prior spinal embolization at the target level
- History of surgery or stenting of the aorta at the level of embolization
- Severe allergic reaction to iodinated contrast (such as anaphylaxis)
- Creatinine level greater than 1.5 mg/dl or creatinine clearance less than 60 mL/min unless on hemodialysis
- Modified Rankin Scale score greater than 2
- Vascular supply to the spinal cord from vessels supplying the targeted facet joints for embolization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment including imaging and diagnostic nerve blocks
Duration - 1 day
Participants undergo trans-arterial embolization of the facet joint using Embozene Microspheres to treat facetogenic low back pain.
1 procedure visit followed by 5 hours of monitoring before discharge
Duration - 1 year
Participants are monitored for safety and efficacy outcomes after the embolization procedure.
Periodic follow-up visits to assess pain improvement and adverse events over 1 year
Trial Site Locations
Total: 1 location
1
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
Research Team
B
Betsy Moclair
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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