Trans-arterial embolization to treat lumbar facet joint pain

Trans Arterial Embolization for Facet Arthropathy

This single-site effort will try trans-arterial embolization with Embozene microparticles to see if it reduces lumbar facet (facetogenic) pain in adults with osteoarthritis who have not improved with standard treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (Manhasset, New York)
• Trial ID: NCT06965452 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–85 with MRI/CT-confirmed lumbar facet arthropathy, diagnostic nerve-block–confirmed facetogenic pain lasting at least six months with pain ≥6/10, who have failed conservative care and are limited to a maximum of two affected lumbar/sacral levels.

Not a fit: Patients with more than two affected levels, prior spinal embolization at the target level, significant renal impairment or iodinated contrast allergy, Modified Rankin Scale >2, or pain from non-facet causes are unlikely to benefit.

Why it matters

Potential benefit: If successful, the procedure could offer a minimally invasive option to reduce chronic lumbar facet pain and improve function in patients with facet arthropathy.

How similar studies have performed: Embolization has shown benefit and acceptable safety for osteoarthritis in other joints and for preoperative spinal tumor embolization, but embolization specifically for facet arthropathy is novel and lacks large controlled trials.

Eligibility criteria

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 this trial is running

Manhasset, New York

• North Shore University Hospital — Manhasset, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Betsy Moclair

Conditions: Facet Joint Arthropathy, Pain, Osteoarthritis, Facetogenic pain, Facet pain, Facet joint pain, Low back pain, Back Pain