A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.
Journal
North American Spine Society journal
ISSN: 2666-5484
Titre abrégé: N Am Spine Soc J
Pays: United States
ID NLM: 9918335076906676
Informations de publication
Date de publication:
10 2020
10 2020
Historique:
received:
27
05
2020
revised:
29
07
2020
accepted:
15
09
2020
entrez:
10
2
2022
pubmed:
18
9
2020
medline:
18
9
2020
Statut:
epublish
Résumé
The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria. Prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with BVN ablation. Inclusion criteria required more than 6 months of CLBP and type 1 or 2 Modic changes on MRI to be enrolled. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L and SF-36 patient reported outcome metrics.Results: 47 patients successfully received BVN ablation and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 +/- 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months (p<0.001) and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15 (each p<0.001). This data supports the clinical effectiveness of BVN ablation in the community practice setting, with similar 12 month improvements in patient reported outcomes as seen in previously published randomized control trials.
Sections du résumé
Background
The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria.
Methods
Prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with BVN ablation. Inclusion criteria required more than 6 months of CLBP and type 1 or 2 Modic changes on MRI to be enrolled. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L and SF-36 patient reported outcome metrics.Results: 47 patients successfully received BVN ablation and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 +/- 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months (p<0.001) and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15 (each p<0.001).
Conclusions
This data supports the clinical effectiveness of BVN ablation in the community practice setting, with similar 12 month improvements in patient reported outcomes as seen in previously published randomized control trials.
Identifiants
pubmed: 35141598
doi: 10.1016/j.xnsj.2020.100030
pii: S2666-5484(20)30030-5
pmc: PMC8819913
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100030Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2020 The Authors. Published by Elsevier Ltd on behalf of North American Spine Society.
Références
Eur Spine J. 2016 Nov;25(11):3723-3734
pubmed: 26914098
PLoS One. 2018 Aug 1;13(8):e0200677
pubmed: 30067777
Pain Med. 2013 Mar;14(3):362-73
pubmed: 23279658
BMJ. 1992 Jul 18;305(6846):160-4
pubmed: 1285753
Eur Spine J. 2006 Sep;15(9):1312-9
pubmed: 16896838
J Bone Joint Surg Br. 1994 Sep;76(5):757-64
pubmed: 8083266
Eur Spine J. 2018 May;27(5):1146-1156
pubmed: 29423885
J Anat. 2011 Mar;218(3):263-70
pubmed: 21223256
Spine J. 2008 Nov-Dec;8(6):968-74
pubmed: 18201937
Spine (Phila Pa 1976). 2000 May 15;25(10):1270-7
pubmed: 10806505
Curr Mol Biol Rep. 2018 Dec;4(4):151-160
pubmed: 30546999
Spine J. 2012 Nov;12(11):1035-9
pubmed: 23199409
Eur Spine J. 2019 Jul;28(7):1594-1602
pubmed: 31115683
Spine J. 2017 Feb;17(2):218-223
pubmed: 27592808
J Spinal Disord. 1998 Dec;11(6):526-31
pubmed: 9884299
Arch Intern Med. 2009 Feb 9;169(3):251-8
pubmed: 19204216
Global Spine J. 2013 Jun;3(3):153-64
pubmed: 24436866
Qual Life Res. 2013 Sep;22(7):1717-27
pubmed: 23184421
Pain. 1983 Sep;17(1):45-56
pubmed: 6226917
J Pain Res. 2012;5:381-90
pubmed: 23091395
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Eur Spine J. 1998;7(5):363-8
pubmed: 9840468
Spine (Phila Pa 1976). 2003 Dec 1;28(23):2570-6
pubmed: 14652473
Eur Spine J. 2007 Nov;16(11):1776-88
pubmed: 17619914
Eur Spine J. 2016 Jun;25(6):1932-8
pubmed: 26077098
World Neurosurg. 2019 Jan;121:e426-e432
pubmed: 30267950
Neuromodulation. 2014 Oct;17 Suppl 2:3-10
pubmed: 25395111
J Clin Epidemiol. 1998 Nov;51(11):903-12
pubmed: 9817107
Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694
pubmed: 26991822
Pain Physician. 2015 Nov;18(6):E939-1004
pubmed: 26606031
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24
pubmed: 11124727
Spine J. 2019 Oct;19(10):1620-1632
pubmed: 31229663
Pain. 2003 Oct;105(3):387-392
pubmed: 14527699
Spine J. 2003 Jan-Feb;3(1):63-7
pubmed: 14589248
JAMA. 2017 Jul 4;318(1):68-81
pubmed: 28672319
Eur Spine J. 2020 Aug;29(8):1925-1934
pubmed: 32451777