Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain (NCT07696507) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Italy69 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Oswestry Disability Index Score From Baseline to 3 Months
Timeframe: Baseline and 3 months after treatment
2
Completion of the Ablation Procedure Without Device-Related Adverse Events
Timeframe: During the procedure and through completion of the post-procedure assessment on the day of treatment
. 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.
Exclusion criteria
. 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.
. 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.