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New treatment option for Facet Joint Arthropathy
Official title Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
ClinicalTrials.gov ID: NCT06965452
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join if
- \- 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
See the full eligibility 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
- \- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Manhasset, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manhasset, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.