Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain (BASILEA)

Inclusion Criteria:

1. Male or female skeletally mature participants aged 25 years or older.
2. Chronic low back pain for at least 6 months.
3. Failure to respond to at least 6 months of non-operative conservative care.
4. Oswestry Disability Index (ODI) score at time of evaluation of at least 30 points.
5. Baseline Visual Analogue Scale (VAS) pain score of at least 4 cm on a 10 cm scale.
6. Modic type 1 changes, or Modic type 2 changes only when associated with edema-like signal changes on T2/STIR sequences, in at least one vertebral endplate at one or more levels from L3 to S1, confirmed by MRI and considered clinically concordant with vertebrogenic low back pain.
7. No radiological evidence of impending vertebral fracture or structural instability at the planned treatment level(s).
8. Able to read, write, speak, and understand the Italian language; willing and able to provide signed and dated informed consent; and willing and able to comply with the study plan, follow-up visits, and scheduled study contacts.

Exclusion Criteria:

1. History or evidence within the past 12 months of radicular pain, radiculopathy, or clinically relevant neuropathic deficit.
2. Planned treatment in more than three adjacent vertebrae in the same procedure.
3. Current or history of symptomatic spinal canal stenosis, vertebral cancer, spinal metastasis, or spinal infection.

4. Any MRI or other imaging evidence of alternative or additional clinically relevant lumbar pathology that could explain the participant's pain or confound study outcomes, such as:

   • nerve root compression, neurogenic claudication, or severe thecal sac effacement correlating with radicular pain, neurologic symptoms, or muscle weakness;
   • disc herniation, protrusion, extrusion, or other disc pathology at any lumbar level when clinically correlated with radicular pain or neurologic findings;
   • facet arthrosis or facet effusion at any lumbar level correlating with clinical evidence of facet-mediated low back pain;
   • spondylolisthesis greater than or equal to 2 mm at any lumbar level;
   • spondylolysis at any level.
5. Previous lumbar spine surgery considered by the Investigator to interfere with target interpretation, procedural feasibility, or study endpoint evaluation.
6. Osteoporosis, defined as T-score less than or equal to -2.5.
7. Metabolic bone disease, such as osteogenesis imperfecta.
8. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.
9. Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.
10. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise attributable to a cause other than vertebrogenic pain.
11. Body mass index (BMI) greater than or equal to 40.
12. Planned treatment site(s) associated with clinically relevant radicular compression and/or spinal canal compromise requiring surgical decompression.
13. Contraindication to MRI, or known allergy/hypersensitivity to any material or component relevant to the investigational procedure.
14. Pregnant, breastfeeding, or planning to become pregnant during the study duration.
15. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
16. Any condition that would interfere with the participant's ability to comply with study instructions or might confound study interpretation.
17. Any medical condition that may substantially interfere with follow-up or confound pain and disability assessment, such as fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, or reflex sympathetic dystrophy.
18. Implantation with a heart pacemaker or another implanted electronic device.
19. Evidence of substance abuse or dependence, or use of prescribed extended-release narcotics within the 3 months prior to screening that, in the Investigator's judgment, may interfere with pain assessment, study compliance, or interpretation of study outcomes.