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

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.

Conditions4

Locations1 site

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