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Clinical Trial

Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

NCT: NCT07696507 · NOT_YET_RECRUITING

NCT IDNCT07696507
StatusNOT_YET_RECRUITING
Start Date2026-09
Completion2028-03
SponsorAxon srl (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain?

Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain is a clinical trial registered under NCT07696507. Current status: NOT_YET_RECRUITING.

What is the status of NCT07696507?

The current status of NCT07696507 (Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain) is: NOT_YET_RECRUITING.

When did Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain start?

Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain started on 2026-09.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.