Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain treatment, including the method optimization.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Axial low back pain (with or without lateral component).
* Presence of Modic type I or II changes at ≥ 1 level.
* Age over 18 years.
* Duration of pain ≥ 6 months.
* Completion of full conservative management for ≥ 3 months.
* Medial Branch Block (MBB) test performed with negative results/ or Facet Denervation done with unsatisfactory outcome (less than 50% improvement) after positive MBB test.
Exclusion Criteria:
* Coagulation disorders.
* Platelet abnormalities.
* Lack of informed consent.
* Generalized solid tumor.
* Hematopoietic malignancy.
* Radicular pain.
* Alternative primary pain generators other than axial low back pain.
* Previous spinal surgery.
* Targeted level located above L3/L4
* Osteoporosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing monopolar basivertebral nerve ablation specifically for axial low back pain — how confident are you that my pain is actually coming from the basivertebral nerve, and does my diagnosis fit the type this procedure is designed to treat?
2Since this trial is listed as Phase NA, what does that mean for how much is already known about the safety and effectiveness of this particular monopolar approach compared to versions of basivertebral nerve ablation that have already been studied?
3The main thing this trial is measuring is the Oswestry Disability Index — can you walk me through what that score means for someone like me, and how big an improvement would actually make a noticeable difference in my day-to-day life?
4Are there standard non-surgical treatments I haven't fully tried yet that might help my axial low back pain before considering an ablation procedure in a research setting?
5What does the ablation procedure actually involve physically, and are there any risks specific to the monopolar technique being tested here that I should weigh against my other options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.