Trans-arterial embolization to treat lumbar facet joint pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, single-arm study enrolls adults with MRI/CT-confirmed lumbar facet arthropathy and diagnostic-block–confirmed facetogenic pain who have failed conservative and procedural care. Participants undergo spinal angiography and trans-arterial embolization of the dorsal branch arteries supplying the affected facet levels using Embozene microspheres, with up to two lumbar/sacral levels treated. The study tracks feasibility, safety, tolerability, and pain and functional outcomes over follow-up visits to determine whether embolization provides meaningful symptom relief. Embolization of spinal segmental arteries is established for tumor management, but its use for facet joint osteoarthritis is novel and this single-arm design seeks preliminary efficacy and safety data.

Why it matters

Who can join: the full rules

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's running

• North Shore University Hospital
  Manhasset, New York, United States Recruiting

Study contacts

• Principal investigator: Athos Patsalides, MD — Northwell Health
• Study coordinator: Betsy Moclair
• Email: bmoclair@northwell.edu
• Phone: 516-253-7753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.