Intraosseous basivertebral nerve ablation: A 5-year pooled analysis from three prospective clinical trials

Area of Science:

• Pain Management
• Interventional Radiology
• Spinal Surgery

Background:

• Vertebrogenic pain, a cause of chronic low back pain (CLBP), originates from damaged vertebral endplates and is transmitted by the basivertebral nerve (BVN).
• Modic changes (MC) on MRI indicate endplate damage, classifying it as Type 1 or Type 2.
• Intraosseous radiofrequency ablation of the BVN (BVNA) is a treatment for vertebrogenic pain, with its clinical impact and safety previously shown in prospective trials.

Purpose of the Study:

• To report aggregate five-year outcomes of basivertebral nerve ablation (BVNA) from three distinct clinical trials.
• To assess the long-term safety and efficacy of BVNA in patients suffering from vertebrogenic pain.

Main Methods:

• Pooled data from three prospective, open-label, single-arm follow-up studies of BVNA treatment.
• Analysis included 249 participants with baseline and five-year follow-up data, assessing Oswestry disability index (ODI) and numeric pain scores (NPS).
• Statistical analysis utilized paired t-tests, with secondary outcomes including responder rates, patient satisfaction, adverse events, and healthcare utilization.

Main Results:

• At five years, significant improvements were observed in NPS (mean decrease of 4.32) and ODI (mean decrease of 28.0) compared to baseline.
• 32.1% of patients reported being pain-free (NPS=0), 72.7% experienced overall improvement, and 68.7% resumed pre-CLBP activity levels.
• Opioid use decreased by 65.2%, spinal injections by 58.1%, and serious device-related adverse events were not reported.

Conclusions:

• Intraosseous BVNA is a safe and effective treatment for vertebrogenic pain, offering significant and durable improvements in pain and function up to five years.
• BVNA leads to substantial reductions in opioid consumption and the need for further spinal interventions.
• The procedure exhibits a strong safety profile with low healthcare utilization for the treated pain source, supporting its long-term viability.