Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

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.

Conditions

• Low Back Pain
• Chronic Low Back Pain (CLBP)

Interventions

DEVICE

Single Bipolar Ablation

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/or CT. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region according to the protocol-defined parameters.

DEVICE

Double Parallel Bipolar Ablation

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/or CT, and positioned according to the protocol-defined parallel configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.

DEVICE

Double Cross Bipolar Ablation

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/or CT, and positioned according to the protocol-defined cross configuration. Controlled bipolar radiofrequency energy is delivered to the intended basivertebral nerve target region.

Sponsors & Collaborators

• Axon srl

  lead INDUSTRY

Principal Investigators

• Mario Muto, MD · Azienda Ospedaliera Antonio Cardarelli

• Pierluca Rocca, MD · Azienda Ospedaliera di Cosenza

• Emanuele Piras, MD · Ospedale Santissima Trinità

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-01-31

Completion

2028-03-31

Countries

• Italy

Study Locations