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

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...

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Autores principales:	Theodore Koreckij, Scott Kreiner, Jad G. Khalil, M. Smuck, J. Markman, Steven Garfin
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Chronic low back pain Basivertebral nerve Basivertebral nerve ablation Radiofrequency ablation Modic Vertebrogenic pain Orthopedic surgery RD701-811 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/1667a93b038c4ad4bc0d7f6c6ba9c35b
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spelling	oai:doaj.org-article:1667a93b038c4ad4bc0d7f6c6ba9c35b2021-11-12T04:48:28ZProspective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results2666-548410.1016/j.xnsj.2021.100089https://doaj.org/article/1667a93b038c4ad4bc0d7f6c6ba9c35b2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S266654842100041Xhttps://doaj.org/toc/2666-5484Background: 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.Theodore KoreckijScott KreinerJad G. KhalilM. SmuckJ. MarkmanSteven GarfinElsevierarticleChronic low back painBasivertebral nerveBasivertebral nerve ablationRadiofrequency ablationModicVertebrogenic painOrthopedic surgeryRD701-811Neurology. Diseases of the nervous systemRC346-429ENNorth American Spine Society Journal, Vol 8, Iss , Pp 100089- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Chronic low back pain Basivertebral nerve Basivertebral nerve ablation Radiofrequency ablation Modic Vertebrogenic pain Orthopedic surgery RD701-811 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Chronic low back pain Basivertebral nerve Basivertebral nerve ablation Radiofrequency ablation Modic Vertebrogenic pain Orthopedic surgery RD701-811 Neurology. Diseases of the nervous system RC346-429 Theodore Koreckij Scott Kreiner Jad G. Khalil M. Smuck J. Markman Steven Garfin Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results
description	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.
format	article
author	Theodore Koreckij Scott Kreiner Jad G. Khalil M. Smuck J. Markman Steven Garfin
author_facet	Theodore Koreckij Scott Kreiner Jad G. Khalil M. Smuck J. Markman Steven Garfin
author_sort	Theodore Koreckij
title	Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results
title_short	Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results
title_full	Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results
title_fullStr	Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results
title_full_unstemmed	Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results
title_sort	prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-month treatment arm results
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/1667a93b038c4ad4bc0d7f6c6ba9c35b
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Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results

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