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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 3
- 主要终点
- Mean Change in Oswestry Disability Index Score From Baseline to 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
- •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.
结局指标
主要结局
Mean Change in Oswestry Disability Index Score From Baseline to 3 Months
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Procedural Success(During the procedure and 6 weeks after treatment)