Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

NCT07696507 | Not Yet Recruiting

• 1 other identifier: 2026-01-EU
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Low Back Pain; Chronic Low Back Pain (CLBP)

Keywords

Basivertebral Nerve Ablation; Radiofrequency Ablation; Vertebrogenic Pain; Modic Changes; Oswestry Disability Index; Spinery; BASILEA; Minimally Invasive Spine Procedure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (6)

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

  Baseline and 6 months after treatment

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

  Baseline, 3 months, and 6 months after treatment

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

  Baseline, 3 months, and 6 months after treatment

• Technical Success of the Ablation Procedure

  During the procedure

• Targeting Success Confirmed by 6-Week MRI

  6 weeks after treatment

Study Arms (3)

Single Bipolar Ablation

EXPERIMENTAL

Participants assigned to this arm will receive active treatment using the Spinery® RF Generator and its sterile single-use accessories with the single bipolar ablation modality. In this approach, one cooled bipolar radiofrequency probe is introduced percutaneously into the target vertebral body under imaging guidance, such as fluoroscopy and/or CT, according to the protocol-defined procedure. Radiofrequency energy is delivered by the Spinery® RF Generator through the dedicated sterile single-use accessories to treat the intended basivertebral nerve target region. The number of treated vertebral bodies is determined according to the protocol-defined affected level(s), from L3 to S1. Participants will undergo the same post-treatment assessments as the other study arms, including MRI at approximately 6 weeks and clinical follow-up at 3 and 6 months.

Device: Single Bipolar Ablation

Double Parallel Bipolar Ablation

EXPERIMENTAL

Participants assigned to this arm will receive active treatment with the Spinery® RF Generator and its sterile single-use accessorie using the double parallel bipolar ablation modality. In this approach, 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. Radiofrequency energy is delivered by the Spinery® RF Generator through the dedicated sterile single-use accessories to treat the intended basivertebral nerve target region. The number of treated vertebral bodies is determined according to the protocol-defined affected level(s), from L3 to S1. Participants will undergo the same post-treatment assessments as the other study arms, including MRI at approximately 6 weeks and clinical follow-up at 3 and 6 months.

Device: Double Parallel Bipolar Ablation

Double Cross Bipolar Ablation

EXPERIMENTAL

Participants assigned to this arm will receive active treatment with the Spinery® RF Generator and its sterile single-use accessorie using the double cross bipolar ablation modality. In this approach, 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. Radiofrequency energy is delivered by the Spinery® RF Generator through the dedicated sterile single-use accessories to treat the intended basivertebral nerve target region. The number of treated vertebral bodies is determined according to the protocol-defined affected level(s), from L3 to S1. Participants will undergo the same post-treatment assessments as the other study arms, including MRI at approximately 6 weeks and clinical follow-up at 3 and 6 months.

Device: Double Cross Bipolar Ablation

Interventions

Single Bipolar Ablation DEVICE

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.

Also known as: Spinery® RF Generator, Spinery® Kit, Spinery® Cooling Connection

Single Bipolar Ablation

Double Parallel Bipolar Ablation DEVICE

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.

Also known as: Spinery® RF Generator, Spinery® Kit, Spinery® Cooling Connection

Double Parallel Bipolar Ablation

Double Cross Bipolar Ablation DEVICE

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.

Also known as: Spinery® RF Generator, Spinery® Kit, Spinery® Cooling Connection

Double Cross Bipolar Ablation

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axon srl: lead

Study Sites (3)

Ospedale Santissima Trinità

Cagliari, Italy

Location

Azienda Ospedaliera di Cosenza

Cosenza, Italy

Location

Azienda Ospedaliera Antonio Cardarelli - U.O.C. Neuroradiologia

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mario Muto, MD

  Azienda Ospedaliera Antonio Cardarelli

  PRINCIPAL INVESTIGATOR

• Pierluca Rocca, MD

  Azienda Ospedaliera di Cosenza

  PRINCIPAL INVESTIGATOR

• Emanuele Piras, MD

  Ospedale Santissima Trinità

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Lucarelli

CONTACT

+390812290044; f.lucarelli@axon.productions

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1:1 ratio to one of three active ablation modalities using the Spinery® RF Generator and its sterile single-use accessories: single bipolar ablation, double parallel bipolar ablation, or double cross bipolar ablation. All participants receive the investigational active treatment. There is no untreated, sham, or concurrent control group. Randomization is used to distribute participants in a balanced manner across the three protocol-defined technical approaches. The study is designed primarily to evaluate the safety, performance, and treatment effect of the Spinery® RF Generator and accessories in the pooled study population. The primary analysis will therefore be performed on the pooled population, with adjustment for investigational center and ablation modality, rather than as a formal head-to-head comparison of the three modalities.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)