Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

N/ANot Yet RecruitingNCT07696507

Axon srl69 enrolled

Overview

The goal of this clinical trial is to learn whether the Spinery® RF Generator and its sterile single-use accessories can safely lower disability and pain in adults with long-term low back pain that is thought to come from changes inside the vertebral bones of the lower spine. This type of pain is called vertebrogenic chronic low back pain. The study will include adults whose low back pain has lasted for at least 6 months and has not improved enough with non-surgical care. Participants must also have specific changes on spine magnetic resonance imaging (MRI), called Modic type 1 changes or selected Modic type 2 changes, at one or more levels between L3 and S1. The main questions this study aims to answer are: * Does the treatment improve daily function 3 months after the procedure? * Does the treatment lower low back pain? * Does the treatment improve quality of life? * What medical problems happen during or after the procedure? * Does the 6-week MRI show that the treatment reached the intended area inside the vertebra? All participants will receive treatment with the Spinery® RF Generator and accessories. There is no untreated comparison group. Participants will be assigned by chance to one of three ways of performing the radiofrequency ablation procedure. Radiofrequency ablation uses controlled heat to treat a small target area. In this study, the target is the basivertebral nerve, a nerve inside the vertebral body that may contribute to low back pain in some people. Participants will: * have screening tests, including spine MRI; * complete questionnaires about pain, daily function, and quality of life; * undergo the radiofrequency ablation procedure with the Spinery® RF Generator and accessories; * have an MRI about 6 weeks after treatment; * attend follow-up visits at 3 months and 6 months; * report any medical problems or changes in pain treatment during the study.

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.

Interventions

Single Bipolar AblationDEVICE

Single bipolar ablation is performed using the Spinery® RF Generator and its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. In this modality, one cooled bipolar radiofrequency probe is introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region according to the protocol-defined parameters.

Double Parallel Bipolar AblationDEVICE

Double parallel bipolar ablation is performed using the Spinery® RF Generator and its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. In this modality, two cooled bipolar radiofrequency probes are introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, and positioned according to the protocol-defined parallel configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.

Double Cross Bipolar AblationDEVICE

Double cross bipolar ablation is performed using the Spinery® RF Generator and its dedicated sterile single-use accessories, including the Spinery® Kit and the Spinery® Cooling Connection. In this modality, two cooled bipolar radiofrequency probes are introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, and positioned according to the protocol-defined cross configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mean Change in Oswestry Disability Index Score From Baseline to 3 Months

The Oswestry Disability Index is used to assess disability related to low back pain. The score ranges from 0 to 100, where 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse disability. The change will be calculated as the Oswestry Disability Index score at 3 months minus the Oswestry Disability Index score at baseline. A negative change indicates improvement, while a positive change indicates worsening.

Time frame: Baseline and 3 months after treatment

Completion of the Ablation Procedure Without Device-Related Adverse Events

This outcome evaluates whether the ablation procedure is completed without adverse events related to the investigational device. Device-related adverse events will be assessed by the investigator according to the protocol.

Time frame: During the procedure and through completion of the post-procedure assessment on the day of treatment

Secondary Outcomes

Mean Change in Oswestry Disability Index Score From Baseline to 6 Months

The Oswestry Disability Index is used to assess disability related to low back pain. The score ranges from 0 to 100, where 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse disability. The change will be calculated as the Oswestry Disability Index score at 6 months minus the Oswestry Disability Index score at baseline. A negative change indicates improvement, while a positive change indicates worsening.

Time frame: Baseline and 6 months after treatment

Mean Change in Visual Analogue Scale Pain Score From Baseline to 3 and 6 Months

The Visual Analogue Scale is used to assess low back pain intensity. The score ranges from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain. The change will be calculated as the Visual Analogue Scale score at each follow-up visit minus the Visual Analogue Scale score at baseline. A negative change indicates improvement, while a positive change indicates worsening.

Time frame: Baseline, 3 months, and 6 months after treatment

Mean Change in EQ-5D-5L Index Score From Baseline to 3 and 6 Months

The EuroQol 5-Dimension 5-Level index score is used to assess health-related quality of life. In this study, the index score will be calculated using the Italian EQ-5D-5L value set. Scores range from -0.571 to 1, where -0.571 represents the worst health state and 1 represents full health. Higher scores indicate better health-related quality of life. The change will be calculated at 3 months and 6 months compared with baseline. A positive change indicates improvement, while a negative change indicates worsening.

Time frame: Baseline, 3 months, and 6 months after treatment

Technical Success of the Ablation Procedure

Technical successTechnical success is defined as the ability to access the treatment site and complete the ablation procedure according to the protocol-defined procedure. is defined as the ability to access the treatment site and complete the ablation procedure according to the protocol-defined procedure.

Time frame: During the procedure

Targeting Success Confirmed by 6-Week MRI

Targeting success is defined as successful targeting of the intended basivertebral region, confirmed by magnetic resonance imaging performed approximately 6 weeks after treatment according to the protocol-defined imaging criteria.

Time frame: 6 weeks after treatment

Procedural Success

Procedural success is defined as successful completion of the procedure with achievement of both technical success and targeting success according to the protocol-defined criteria.

Time frame: During the procedure and 6 weeks after treatment