Dataset Information

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

ABSTRACT:

Background

Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation, visible as types 1 or 2 Modic changes. A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showed significant differences between arms at 3 and 6-months. At 12-months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24-months.

Methods

Prospective, open label, single-arm follow-up of the BVNA treatment arm of a RCT in 20 US sites with visits at 6-weeks, and 3, 6, 9, 12 and 24-months. Paired comparisons to baseline were made for the BVNA arm at each timepoint for Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Short Form Health Survey (SF-36), EQ-5D-5L, and responder rates.

Results

140 patients were randomized, 66 to BVNA. In the 58 BVNA patients completing a 24-month visit, 67% had back pain for >5 years, 36% were actively taking opioids at baseline, 50% had prior epidural steroid injections, and 12% had prior low back surgery. Improvements in ODI, VAS, SF-36 PCS, and EQ-5D-5L were statistically significant at all timepoints through 2 years. At 24 months, ODI and VAS improved 28.5±16.2 points (from baseline 44.5; p < 0.001) and 4.1±2.7 cm (from baseline 6.6; p < 0.001), respectively. A combined responder rate of ODI≥15 and VAS≥2 was 73.7%. A ≥50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years. At 24 months, only 3(5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids. There were no serious device or device-procedure related adverse events reported through 24 months.

Conclusion

Intraosseous BVNA demonstrates an excellent safety profile and significant improvements in pain, function, and quality of life that are sustained through 24 months in patients with chronic vertebrogenic low back pain.

SUBMITTER: Koreckij T

PROVIDER: S-EPMC8820067 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

Koreckij Theodore T Kreiner Scott S Khalil Jad G JG Smuck M M Markman J J Garfin Steven S

North American Spine Society journal 20211026

<h4>Background</h4>Vertebral endplates, innervated by the basivertebral nerve, can be a source of vertebrogenic low back pain when damaged with inflammation, visible as types 1 or 2 Modic changes. A randomized controlled trial (RCT) compared basivertebral nerve ablation (BVNA) to standard care (SC) showed significant differences between arms at 3 and 6-months. At 12-months, significant improvements were sustained for BVNA. We report results of the BVNA arm at 24-months.<h4>Methods</h4>Prospectiv ...[more]

PMID: 35141653

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Project description:IntroductionVertebral endplates, innervated by the basivertebral nerve (BVN), are a source of chronic low back pain correlated with Modic changes. A randomized trial comparing BVN ablation to standard care (SC) recently reported results of an interim analysis. Here, we report the results of the full randomized trial, including the 3-month and 6-month between-arm comparisons, 12-month treatment arm results, and 6-month outcomes of BVN ablation in the former SC arm.MethodsProspective, open label, 1:1 randomized controlled trial of BVN ablation versus SC in 23 US sites with follow-up at 6 weeks, 3, 6, 9, and 12 months. SC patients were re-baselined and followed up for 6 months post BVN ablation. The primary endpoint was the between-arm comparison of mean Oswestry Disability Index (ODI) change from baseline. Secondary endpoints were Visual Analog Scale (VAS), Short Form (SF-36), EuroQual Group 5 Dimension 5-Level Quality of Life (EQ-5D-5L), responder rates, and rates of continued opioid use.Results140 were randomized. Results from BVN ablation (n=66) were superior to SC (n=74) at 3 months for the primary endpoint (mean ODI reduction, difference between arms of -20.3 (CI -25.9 to -14.7 points; p<0.001)), VAS pain improvement (difference of -2.5 cm between arms (CI -3.37 to -1.64, p<0.001)) and quality of life outcomes. At 12 months, basivertebral ablation demonstrated a 25.7±18.5 point reduction in mean ODI (p<0.001), and a 3.8±2.7 cm VAS reduction (p<0.001) from baseline, with 64% demonstrating ≥50% reduction and 29% pain free. Similarly, the former SC patients who elected BVN ablation (92%) demonstrated a 25.9±15.5 point mean ODI reduction (p<0.001) from baseline. The proportion of opioid use did not change in either group (p=0.56).Discussion/conclusionBVN ablation demonstrates significant improvements in pain and function over SC, with treatment results sustained through 12 months in patients with chronic low back pain of vertebrogenic origin.

Project description:BackgroundVertebrogenic pain is an established source of anterior column chronic low back pain (CLBP) resulting from damaged vertebral endplates with pain signals transmitted by the basivertebral nerve (BVN). Type 1 or Type 2 Modic changes on magnetic resonance imaging (MRI) are objective biomarkers for vertebrogenic pain. Radiofrequency ablation of the BVN (BVNA) has demonstrated both efficacy and effectiveness for the treatment of vertebrogenic pain in two randomized trials. Here, we report 3-year aggregate results from two prospective studies of BVNA-treated patients.MethodsPooled results at 3 years post-BVNA are reported for two studies with similar inclusion/exclusion criteria and outcomes measurements: 1) a prospective, open label, single-arm follow-up of the treatment arm of a randomized controlled trial (RCT) comparing BVNA to standard care (INTRACEPT Trial), and 2) a prospective, open label, single cohort long-term follow-up study of BVNA-treated patients. Paired datasets (baseline and 3-years) for mean changes in Oswestry disability index (ODI) and numeric pain scores (NPS) were analyzed using a two-sided t-test with a 0.05 level of significance.ResultsThere were 95/113 (84%) BVNA patients who completed a 3-year visit across 22 study sites. At baseline, 71% of patients reported back pain for ≥5 years, 28% were taking opioids, 34% had spinal injections in the prior 12 months, and 14% had prior low back surgery. Pain and functional improvements were significant at 3 years with a mean reduction in NPS of 4.3 points from 6.7 at baseline (95% CI 3.8, 4.8; p<0.0001) and a mean reduction in ODI of 31.2 points from 46.1 at baseline (95% CI 28.4, 34.0; p<0.0001). Responder rates, using minimal clinically important differences of ≥15-points for ODI and ≥50% reduction in NPS from baseline to three years, were 85.3% and 72.6%, respectively (combined response 69.5%), with 26.3% of patients reporting 100% pain relief at 3 years. There was a 74% reduction in the use of opioids and 84% reduction in the use of therapeutic spinal interventions from baseline to 3 years. There were no serious device or device-procedure related adverse events reported through three years.ConclusionIntraosseous BVNA demonstrates statistically significant, clinically meaningful, and durable improvements in pain and function through 3 years in patients with primary vertebrogenic low back pain. BVNA-treated patients significantly reduced opioid use and interventions for low back pain.

Dataset Information

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

Background

Methods

Results

Conclusion

Publications

Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results.

Similar Datasets

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