[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646125":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":52,"locations":59,"responsibleParty":99,"collaborators":57,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":57,"enrollmentInfo":111,"targetDuration":57,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":129,"whyStopped":57,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Axon srl","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002For 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.",[13],"Device: Single Bipolar Ablation",{"label":15,"type":10,"description":16,"interventionNames":17},"Double Parallel Bipolar Ablation","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\u002For 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.",[18],"Device: Double Parallel Bipolar Ablation",{"label":20,"type":10,"description":21,"interventionNames":22},"Double Cross Bipolar Ablation","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\u002For 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.",[23],"Device: Double Cross Bipolar Ablation",[25,33,37],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"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\u002For CT. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region according to the protocol-defined parameters.",[9],[30,31,32],"Spinery® RF Generator","Spinery® Kit","Spinery® Cooling Connection",{"type":26,"name":15,"description":34,"armGroupLabels":35,"otherNames":36},"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\u002For CT, and positioned according to the protocol-defined parallel configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.",[15],[30,31,32],{"type":26,"name":20,"description":38,"armGroupLabels":39,"otherNames":40},"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\u002For CT, and positioned according to the protocol-defined cross configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.",[20],[30,31,32],[42,46,49],{"name":43,"affiliation":44,"role":45},"Mario Muto, MD","Azienda Ospedaliera Antonio Cardarelli","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":48,"role":45},"Pierluca Rocca, MD","Azienda Ospedaliera di Cosenza",{"name":50,"affiliation":51,"role":45},"Emanuele Piras, MD","Ospedale Santissima Trinità",[53],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Francesco Lucarelli","CONTACT","+390812290044",null,"f.lucarelli@axon.productions",[60,74,85],{"facility":51,"status":57,"city":61,"state":57,"zip":57,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Cagliari","Italy","IT",{"type":65,"coordinates":66},"Point",[67,68],9.11917,39.23054,{"lat":68,"lon":67},[71],{"name":50,"role":55,"phone":72,"phoneExt":57,"email":73},"+393929420140","emanuele.piras@aslcagliari.it",{"facility":48,"status":57,"city":75,"state":57,"zip":57,"country":62,"countryCode":63,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Cosenza",{"type":65,"coordinates":77},[78,79],16.25307,39.2989,{"lat":79,"lon":78},[82],{"name":47,"role":55,"phone":83,"phoneExt":57,"email":84},"+393488931895","pierluca.rocca@icloud.com",{"facility":86,"status":57,"city":87,"state":57,"zip":88,"country":62,"countryCode":63,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Azienda Ospedaliera Antonio Cardarelli - U.O.C. Neuroradiologia","Naples","80131",{"type":65,"coordinates":90},[91,92],14.26811,40.85216,{"lat":92,"lon":91},[95,98],{"name":43,"role":55,"phone":96,"phoneExt":57,"email":97},"+393357562320","mario.muto@aocardarelli.it",{"name":43,"role":45,"phone":57,"phoneExt":57,"email":57},{"type":100,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100646125","spinery-basivertebral-nerve-ablation-for-vertebrogenic-chronic-low-back-pain-100646125",false,"NCT07696507","Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain","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","BASILEA","Inclusion Criteria:\n\n1. Male or female skeletally mature participants aged 25 years or older.\n2. Chronic low back pain for at least 6 months.\n3. Failure to respond to at least 6 months of non-operative conservative care.\n4. Oswestry Disability Index (ODI) score at time of evaluation of at least 30 points.\n5. Baseline Visual Analogue Scale (VAS) pain score of at least 4 cm on a 10 cm scale.\n6. Modic type 1 changes, or Modic type 2 changes only when associated with edema-like signal changes on T2\u002FSTIR 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.\n7. No radiological evidence of impending vertebral fracture or structural instability at the planned treatment level(s).\n8. 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.\n\nExclusion Criteria:\n\n1. History or evidence within the past 12 months of radicular pain, radiculopathy, or clinically relevant neuropathic deficit.\n2. Planned treatment in more than three adjacent vertebrae in the same procedure.\n3. Current or history of symptomatic spinal canal stenosis, vertebral cancer, spinal metastasis, or spinal infection.\n4. 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:\n\n   * nerve root compression, neurogenic claudication, or severe thecal sac effacement correlating with radicular pain, neurologic symptoms, or muscle weakness;\n   * disc herniation, protrusion, extrusion, or other disc pathology at any lumbar level when clinically correlated with radicular pain or neurologic findings;\n   * facet arthrosis or facet effusion at any lumbar level correlating with clinical evidence of facet-mediated low back pain;\n   * spondylolisthesis greater than or equal to 2 mm at any lumbar level;\n   * spondylolysis at any level.\n5. Previous lumbar spine surgery considered by the Investigator to interfere with target interpretation, procedural feasibility, or study endpoint evaluation.\n6. Osteoporosis, defined as T-score less than or equal to -2.5.\n7. Metabolic bone disease, such as osteogenesis imperfecta.\n8. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.\n9. Active or incompletely treated local infection at the planned treatment site(s) and\u002For systemic infection.\n10. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise attributable to a cause other than vertebrogenic pain.\n11. Body mass index (BMI) greater than or equal to 40.\n12. Planned treatment site(s) associated with clinically relevant radicular compression and\u002For spinal canal compromise requiring surgical decompression.\n13. Contraindication to MRI, or known allergy\u002Fhypersensitivity to any material or component relevant to the investigational procedure.\n14. Pregnant, breastfeeding, or planning to become pregnant during the study duration.\n15. Concurrent participation in another clinical study that may add additional safety risks and\u002For confound study results.\n16. Any condition that would interfere with the participant's ability to comply with study instructions or might confound study interpretation.\n17. 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.\n18. Implantation with a heart pacemaker or another implanted electronic device.\n19. 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.","ALL","25 Years",{"count":112,"type":113},69,"ESTIMATED","INTERVENTIONAL",[116],"NA","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.\n\nThe 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.\n\nThe main questions this study aims to answer are:\n\n* Does the treatment improve daily function 3 months after the procedure?\n* Does the treatment lower low back pain?\n* Does the treatment improve quality of life?\n* What medical problems happen during or after the procedure?\n* Does the 6-week MRI show that the treatment reached the intended area inside the vertebra?\n\nAll 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.\n\nParticipants will:\n\n* have screening tests, including spine MRI;\n* complete questionnaires about pain, daily function, and quality of life;\n* undergo the radiofrequency ablation procedure with the Spinery® RF Generator and accessories;\n* have an MRI about 6 weeks after treatment;\n* attend follow-up visits at 3 months and 6 months;\n* report any medical problems or changes in pain treatment during the study.",[119,120],"Low Back Pain","Chronic Low Back Pain (CLBP)",[122,123,124,125,126,127,107,128],"Basivertebral Nerve Ablation","Radiofrequency Ablation","Vertebrogenic Pain","Modic Changes","Oswestry Disability Index","Spinery","Minimally Invasive Spine Procedure","NOT_YET_RECRUITING","2026-07-09",{"date":132,"type":133},"2026-07-10","ACTUAL",{"date":135,"type":113},"2026-09",{"date":137,"type":113},"2028-03",{"name":5,"class":6},3]