Low Back PainBASILEANCT07696507
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
A study testing Single Bipolar Ablation, Double Parallel Bipolar Ablation and Double Cross Bipolar Ablation in people with Low Back Pain and Chronic Low Back Pain (CLBP), run by Axon srl at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Low Back Pain, Chronic Low Back Pain (CLBP)
- What is being tested?
- Single Bipolar Ablation, Double Parallel Bipolar Ablation and Double Cross Bipolar Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesItaly
- Study dates
- Jan 2027to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 24Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
Ospedale Santissima Trinità
Cagliari
Emanuele Piras, MD, +393929420140, emanuele.piras@aslcagliari.it
Azienda Ospedaliera di Cosenza
Cosenza
Pierluca Rocca, MD, +393488931895, pierluca.rocca@icloud.com
Azienda Ospedaliera Antonio Cardarelli - U.O.C. Neuroradiologia
Naples, 80131
Mario Muto, MD, +393357562320, mario.muto@aocardarelli.it
Mario Muto, MD
About this study
Official title: Clinical Study of a RadioFrequency Basivertebral Nerve Ablation Device (Spinery® RF Generator and Its Sterile Single-use Accessories - the Spinery® Kit and the Spinery® Cooling Connection) for Chronic Low Back Pain (CLBP) Treatments
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Low Back Pain, Chronic Low Back Pain (CLBP)
- Being tested
- Single Bipolar Ablation, Double Parallel Bipolar Ablation, Double Cross Bipolar Ablation
- Keywords
- Basivertebral Nerve Ablation, Radiofrequency Ablation, Vertebrogenic Pain, Modic Changes, Oswestry Disability Index, Spinery, BASILEA, Minimally Invasive Spine Procedure
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Bipolar AblationDevice
Also called Spinery® RF Generator, Spinery® Kit, Spinery® Cooling Connection
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
Also called Spinery® RF Generator, Spinery® Kit, Spinery® Cooling Connection
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
Also called Spinery® RF Generator, Spinery® Kit, Spinery® Cooling Connection
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Double Cross Bipolar Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the procedure and 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axon srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Muto, MD, Principal investigator, Azienda Ospedaliera Antonio CardarelliPierluca Rocca, MD, Principal investigator, Azienda Ospedaliera di CosenzaEmanuele Piras, MD, Principal investigator, Ospedale Santissima Trinità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696507
- Sponsor's protocol ID
- 2026-01-EU
- Acronym
- BASILEA
- Status last verified
- Nov 2026
- First submitted
- 2 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregate study results may be reported in scientific publications, regulatory submissions, and public registry updates.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of a RadioFrequency Basivertebral Nerve Ablation Device (Spinery® RF Generator and Its Sterile Single-use Accessories - the Spinery® Kit and the Spinery® Cooling Connection) for Chronic Low Back Pain (CLBP) Treatments
- ClinicalTrials.gov ID
- NCT07696507
- Acronym / sponsor ID
- BASILEA / 2026-01-EU
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Axon srlIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Bipolar Ablation | Experimental | Device: Single Bipolar AblationParticipants 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. |
| Double Parallel Bipolar Ablation | Experimental | Device: Double Parallel Bipolar AblationParticipants 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. |
| Double Cross Bipolar Ablation | Experimental | Device: Double Cross Bipolar AblationParticipants 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- Previous lumbar spine surgery considered by the Investigator to interfere with target interpretation, procedural feasibility, or study endpoint evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Bipolar AblationAlso: Spinery® RF Generator, Spinery® Kit, Spinery® Cooling ConnectionSingle 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. | Device | Single Bipolar Ablation |
| Double Parallel Bipolar AblationAlso: Spinery® RF Generator, Spinery® Kit, Spinery® Cooling ConnectionDouble 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. | Device | Double Parallel Bipolar Ablation |
| Double Cross Bipolar AblationAlso: Spinery® RF Generator, Spinery® Kit, Spinery® Cooling ConnectionDouble 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. | Device | Double Cross Bipolar Ablation |
Primary outcome
Mean Change in Oswestry Disability Index Score From Baseline to 3 Months
Time frame: Baseline and 3 months after treatment
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.
Completion of the Ablation Procedure Without Device-Related Adverse Events
Time frame: During the procedure and through completion of the post-procedure assessment on the day of treatment
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.
6 secondary outcomes
Mean Change in Oswestry Disability Index Score From Baseline to 6 Months
Time frame: Baseline and 6 months after treatment
Mean Change in Visual Analogue Scale Pain Score From Baseline to 3 and 6 Months
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
Time frame: Baseline, 3 months, and 6 months after treatment
Technical Success of the Ablation Procedure
Time frame: During the procedure
Targeting Success Confirmed by 6-Week MRI
Time frame: 6 weeks after treatment
Procedural Success
Time frame: During the procedure and 6 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregate study results may be reported in scientific publications, regulatory submissions, and public registry updates.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Muto, MD principal investigator
Azienda Ospedaliera Antonio Cardarelli
Pierluca Rocca, MD principal investigator
Azienda Ospedaliera di Cosenza
Emanuele Piras, MD principal investigator
Ospedale Santissima Trinità
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Bipolar Ablation, Double Parallel Bipolar Ablation and Double Cross Bipolar Ablation in people with Low Back Pain and Chronic Low Back Pain (CLBP), run by Axon srl at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Lucarelli (+390812290044, f.lucarelli@axon.productions), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Oswestry Disability Index Score From Baseline to 3 Months (time frame: Baseline and 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.