RecruitingNot ApplicableNCT06965452

Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy

Trans Arterial Embolization for Facet Arthropathy

Sponsor

Northwell Health

Enrollment

40 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Osteoarthritis Facet Joint Arthropathy

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria9

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 Criteria7

\- 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.

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Interventions

DEVICESpinal angiography and embolization/ Embozene Microspheres

Once consent is obtained the patient will be scheduled for spinal angiography and embolization. The patient will undergo the procedure at North Shore University Hospital. After embolization the patient will be monitored in recovery for 5 hours and then discharged to home. The primary objective of this study is to examine the safety and feasibility of trans arterial embolization of the facet joint using Embozene Microspheres for the treatment of back pain from facet arthropathy and osteoarthritis.