Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

BASILEA is a prospective, multicenter, single-arm clinical investigation of the investigational use of the Spinery® RF Generator and its sterile single-use accessories for basivertebral nerve ablation in adults with vertebrogenic chronic low back pain.

Vertebrogenic chronic low back pain is a type of low back pain believed to arise from the vertebral endplates and the vertebral body. In this study, eligible participants must have chronic isolated low back pain that has not responded adequately to at least 6 months of conservative treatment. Participants must also have MRI findings considered consistent with vertebrogenic pain at one or more vertebral levels from L3 to S1. These findings include Modic type 1 changes or Modic type 2 changes only when associated with edema-like signal changes on T2/STIR MRI sequences and considered clinically concordant with the participant's symptoms.

The Spinery® RF Generator is used together with its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. The Spinery® RF Generator is a software-controlled radiofrequency generator designed to deliver controlled bipolar radiofrequency energy. The sterile single-use accessories allow percutaneous vertebral access, positioning of the radiofrequency probe, energy delivery, and probe cooling during the procedure.

The procedure is minimally invasive and percutaneous. During the procedure, the physician introduces one or more radiofrequency probes into the vertebral body under imaging guidance, such as fluoroscopy or computed tomography. The generator then delivers controlled radiofrequency energy to the intended intraosseous target region. The investigational treatment is intended to ablate the basivertebral nerve within the vertebral body.

All participants will receive active treatment. The study does not include a concurrent untreated or sham control group. Participants will be randomized in a 1:1:1 ratio to one of three protocol-defined ablation modalities: single bipolar ablation, double parallel bipolar ablation, or double cross bipolar ablation. This internal randomization is intended to balance the use of the three technical approaches during the study. The main clinical analysis will evaluate the pooled study population rather than formally compare the three ablation modalities as separate treatment groups.

The primary clinical assessment is the change in Oswestry Disability Index score from baseline to 3 months. The Oswestry Disability Index is a questionnaire used to measure how much low back pain affects daily activities. A lower score after treatment indicates improvement in disability.

Safety and performance will also be evaluated. One key safety and performance assessment is the completion of the ablation procedure without device-related adverse events. Additional assessments include pain intensity using the Visual Analogue Scale, quality of life using the EQ-5D-5L questionnaire, technical success, targeting success, procedural success, and adverse events through 6 months of follow-up.

MRI will be performed at baseline and about 6 weeks after treatment. The baseline MRI is used to support participant selection and to document the relevant vertebral findings. The 6-week MRI is used to assess whether the ablation zone reached the intended basivertebral target region inside each treated vertebral body. This MRI assessment supports evaluation of targeting success and is separate from the main clinical effectiveness assessment at 3 months.

Clinical follow-up visits are planned at 3 months and 6 months after treatment. The 3-month visit is used for the primary clinical effectiveness assessment. The 6-month visit is used to evaluate whether any improvement in disability, pain, and quality of life is maintained over time and to continue safety follow-up.

Inclusion criteria

• Male or female skeletally mature participants aged 25 years or older.
• Chronic low back pain for at least 6 months.
• Failure to respond to at least 6 months of non-operative conservative care.
• Oswestry Disability Index (ODI) score at time of evaluation of at least 30 points.
• Baseline Visual Analogue Scale (VAS) pain score of at least 4 cm on a 10 cm scale.
• 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.
• No radiological evidence of impending vertebral fracture or structural instability at the planned treatment level(s).
• 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

• History or evidence within the past 12 months of radicular pain, radiculopathy, or clinically relevant neuropathic deficit.
• Planned treatment in more than three adjacent vertebrae in the same procedure.
• Current or history of symptomatic spinal canal stenosis, vertebral cancer, spinal metastasis, or spinal infection.
• 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.
• Previous lumbar spine surgery considered by the Investigator to interfere with target interpretation, procedural feasibility, or study endpoint evaluation.
• Osteoporosis, defined as T-score less than or equal to -2.5.
• Metabolic bone disease, such as osteogenesis imperfecta.
• Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.
• Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.
• Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise attributable to a cause other than vertebrogenic pain.
• Body mass index (BMI) greater than or equal to 40.
• Planned treatment site(s) associated with clinically relevant radicular compression and/or spinal canal compromise requiring surgical decompression.
• Contraindication to MRI, or known allergy/hypersensitivity to any material or component relevant to the investigational procedure.
• Pregnant, breastfeeding, or planning to become pregnant during the study duration.
• Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.
• Any condition that would interfere with the participant's ability to comply with study instructions or might confound study interpretation.
• 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.
• Implantation with a heart pacemaker or another implanted electronic device.
• 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.