Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorAxon srl
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
nerve root compression, neurogenic claudication, or severe thecal sac effacement correlating with radicular pain, neurologic symptoms, or muscle weakness;
Trial design
Design model
Parallel
Treatments tested in this trial
Single Bipolar Ablation
DeviceSingle 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 Ablation
DeviceDouble 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 Ablation
DeviceDouble 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.
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Single Bipolar AblationExperimental treatment 1 intervention
Group B: Double Parallel Bipolar AblationExperimental treatment 1 intervention
Group C: Double Cross Bipolar AblationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 treatment2
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 treatmentSecondary outcomes
1
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 treatment2
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 treatment3
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 treatment4
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 Source ClinicalTrials.gov
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