Zapping a nerve inside the spine bone may ease chronic back pain
NCT ID NCT07696507
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This trial tests whether a device that uses controlled heat to target a nerve inside the spine bone can safely reduce disability and pain in adults with long-term low back pain. Participants must have had pain for at least 6 months and have specific changes on MRI. All receive the procedure, with no untreated comparison group, and are followed for 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiofrequency basivertebral nerve ablation device (Spinery® RF Generator and accessories)
- What this could lead to
- If successful, this could offer a new, minimally invasive option for people with chronic low back pain that hasn't improved with other treatments.
- What could go wrong
- This is an early study with no comparison group, so results may not prove the device works better than placebo or other treatments. Risks include procedure-related pain, infection, or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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25 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female skeletally mature participants aged 25 years or older. 2. Chronic low back pain for at least 6 months. 3. Failure to respond to at least 6 months of non-operative conservative care. 4. Oswestry Disability Index (ODI) score at time of evaluation of at least 30 points. 5. Baseline Visual Analogue Scale (VAS) pain score of at least 4 cm on a 10 cm scale. 6. 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. 7. No radiological evidence of impending vertebral fracture or structural instability at the planned treatment level(s). 8. 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: 1. History or evidence within the past 12 months of radicular pain, radiculopathy, or clinically relevant neuropathic deficit. 2. Planned treatment in more than three adjacent vertebrae in the same procedure. 3. Current or history of symptomatic spinal canal stenosis, vertebral cancer, spinal metastasis, or spinal infection. 4. 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. 5. Previous lumbar spine surgery considered by the Investigator to interfere with target interpretation, procedural feasibility, or study endpoint evaluation. 6. Osteoporosis, defined as T-score less than or equal to -2.5. 7. Metabolic bone disease, such as osteogenesis imperfecta. 8. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone. 9. Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection. 10. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise attributable to a cause other than vertebrogenic pain. 11. Body mass index (BMI) greater than or equal to 40. 12. Planned treatment site(s) associated with clinically relevant radicular compression and/or spinal canal compromise requiring surgical decompression. 13. Contraindication to MRI, or known allergy/hypersensitivity to any material or component relevant to the investigational procedure. 14. Pregnant, breastfeeding, or planning to become pregnant during the study duration. 15. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results. 16. Any condition that would interfere with the participant's ability to comply with study instructions or might confound study interpretation. 17. 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. 18. Implantation with a heart pacemaker or another implanted electronic device. 19. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliera Antonio Cardarelli - U.O.C. Neuroradiologia
Naples, 80131, Italy
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Azienda Ospedaliera di Cosenza
Cosenza, Italy
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Ospedale Santissima Trinità
Cagliari, Italy
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