How Should we Use Multicolumn Spinal Cord Stimulation to Optimize Back Pain Spatial Neural Targeting? A Prospective, Multicenter, Randomized, Double-Blind, Controlled Trial (ESTIMET Study).
Back pain
failed back surgery syndrome
multicolumn SCS
neural targeting
randomized controlled trial
spinal cord stimulation
sweet spot
Journal
Neuromodulation : journal of the International Neuromodulation Society
ISSN: 1525-1403
Titre abrégé: Neuromodulation
Pays: United States
ID NLM: 9804159
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
21
02
2020
revised:
05
06
2020
accepted:
15
06
2020
pubmed:
1
9
2020
medline:
19
8
2021
entrez:
1
9
2020
Statut:
ppublish
Résumé
Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP). To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead. Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up. At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001). The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.
Sections du résumé
BACKGROUND
BACKGROUND
Recent studies have highlighted multicolumn spinal cord stimulation (SCS) efficacy, hypothesizing that optimized spatial neural targeting provided by new-generation SCS lead design or its multicolumn programming abilities could represent an opportunity to better address chronic back pain (BP).
OBJECTIVE
OBJECTIVE
To compare multicolumn vs. monocolumn programming on clinical outcomes of refractory postoperative chronic BP patients implanted with SCS using multicolumn surgical lead.
MATERIALS AND METHODS
METHODS
Twelve centers included 115 patients in a multicenter, randomized, double-blind, controlled trial. After randomization, leads were programmed using only one or several columns. The primary outcome was change in BP visual analogic scale (VAS) at six months. All patients were then programmed using the full potential of the lead up until 12-months follow-up.
RESULTS
RESULTS
At six months, there was no significant difference in clinical outcomes whether the SCS was programmed using a mono or a multicolumn program. At 12 months, in all patients having been receiving multicolumn SCS for at least six months (n = 97), VAS decreases were significant for global pain (45.1%), leg pain (55.8%), and BP (41.5%) compared with baseline (p < 0.0001).
CONCLUSION
CONCLUSIONS
The ESTIMET study confirms the significant benefit experienced on chronic BP by patients implanted with multicolumn SCS, independently from multicolumn lead programming. These good clinical outcomes might result from the specific architecture of the multicolumn lead, giving the opportunity to select initially the best column on a multicolumn grid and to optimize neural targeting with low-energy requirements. However, involving more columns than one does not appear necessary, once initial spatial targeting of the "sweet spot" has been achieved. Our findings suggest that this spatial concept could also be transposed to cylindrical leads, which have drastically improved their capability to shape the electrical field, and might be combined with temporal resolution using SCS new modalities.
Identifiants
pubmed: 32865344
doi: 10.1111/ner.13251
pii: S1094-7159(21)00143-4
doi:
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
86-101Informations de copyright
© 2020 International Neuromodulation Society.
Références
Skolasky RL, Wegener ST, Maggard AM, Riley LH. The impact of reduction of pain after lumbar spine surgery: the relationship between changes in pain and physical function and disability. Spine 2014;39:1426-1432.
North RB, Kumar K, Wallace MS et al. Spinal cord stimulation versus re-operation in patients with failed back surgery syndrome: an international multicenter randomized controlled trial (EVIDENCE study). Neuromodulation 2011;14:330-335. discussion 335-336.
Rigoard P, Delmotte A, D'Houtaud S et al. Back pain: a real target for spinal cord stimulation? Neurosurgery 2012;70:574-584. discussion 584-585.
Kumar K, North R, Taylor R et al. Spinal cord stimulation vs. conventional medical management: a prospective, randomized, controlled, multicenter study of patients with failed Back surgery syndrome (PROCESS study). Neuromodulation 2005;8:213-218.
Deer TR, Grider JS, Lamer TJ et al. A systematic literature review of spine Neurostimulation therapies for the treatment of pain. Pain Med 2020;21:1421-1432.
Duarte RV, Nevitt S, McNicol E et al. Systematic review and meta-analysis of placebo/sham controlled randomized trials of spinal cord stimulation for neuropathic pain. Pain 2020;161:24-35.
Mertens P, Blond S, David R, Rigoard P. Anatomy, physiology and neurobiology of the nociception: a focus on low back pain (part a). Neurochirurgie 2015;61:S22-S34.
Rigoard P, Blond S, David R, Mertens P. Pathophysiological characterisation of back pain generators in failed back surgery syndrome (part B). Neurochirurgie 2015;61:S35-S44.
Blond S, Mertens P, David R, Roulaud M, Rigoard P. From "mechanical" to "neuropathic" back pain concept in FBSS patients. A systematic review based on factors leading to the chronification of pain (part C). Neurochirurgie 2015;61:S45-S56.
Law JD. Targeting a spinal stimulator to treat the 'failed back surgery syndrome. Appl Neurophysiol 1987;50:437-438.
Gatzinsky K, Baardsen R, Buschman HP. Evaluation of the effectiveness of percutaneous octapolar leads in pain treatment with spinal cord stimulation of patients with failed back surgery syndrome during a 1-year follow-up: a prospective multicenter international study. Pain Pract 2017;17:428-437.
De Ridder D, Vanneste S, Plazier M, Vancamp T. Mimicking the brain: evaluation of St Jude Medical's prodigy chronic pain system with burst technology. Expert Rev Med Devices 2015;12:143-150.
Kapural L, Yu C, Doust MW et al. Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery 2016;79:667-677.
Wille F, Breel JS, Bakker EWP, Hollmann MW. Altering conventional to high density spinal cord stimulation: an energy dose-response relationship in neuropathic pain therapy. Neuromodulation 2017;20:71-80.
Mekhail N, Levy RM, Deer TR et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomized, controlled trial. Lancet Neurol 2020;19:123-134.
Holsheimer J, Barolat G. Spinal geometry and paresthesia coverage in spinal cord stimulation. Neuromodulation 1998;1:129-136.
Rigoard P, Jacques L, Delmotte A et al. An algorithmic programming approach for back pain symptoms in failed back surgery syndrome using spinal cord stimulation with a multicolumn surgically implanted epidural lead: a multicenter international prospective study. Pain Pract 2015;15:195-207.
Rigoard P, Basu S, Desai M et al. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trail. Pain 2019;160:1410-1420.
Roulaud M, Durand-Zaleski I, Ingrand P et al. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET study). Neurochirurgie 2015;61:S109-S116.
Merskey H, Bogduk N. Classification of chronic pain: Descriptions of chronic pain syndromes and definitions of pain terms. 2nd ed. Seattle, WA: IASP Press, 1994;p. 212.
Rigoard P, Luong AT, Delmotte A et al. Multicolumn spinal cord stimulation lead implantation using an optic transligamentar minimally invasive technique. Neurosurgery 2013;73:550-553.
Veizi E, Hayek SM, North J et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low Back pain relief compared to traditional SCS-LUMINA study. Pain Med 2017;18:1534-1548.
Rigoard P, Nivole K, Blouin P et al. A novel, objective, quantitative method of evaluation of the back pain component using comparative computerized multi-parametric tactile mapping before/after spinal cord stimulation and database analysis: the « Neuro-Pain't » software. Neurochirurgie 2015;61 Suppl 1:S99 108:S99-S108.
Kumar K, Taylor RS, Jacques L et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized controlled trial in patients with failed back surgery syndrome. Pain 2007;132:179-188.
Alshurafa M, Briel M, Akl EA et al. Inconsistent definitions for intention-to-treat in relation to missing outcome data: systematic review of the methods literature. PloS One 2012;7:e49163.
De La Cruz P, Fama C, Roth S et al. Predictors of spinal cord stimulation success. Neuromodulation 2015;18:599-602. discussion 602.
Kumar K, Rizvi S, Nguyen R, Abbas M, Bishop S, Murthy V. Impact of wait times on spinal cord stimulation therapy outcomes. Pain Pract Off J World Inst Pain 2014;14:709-720.
Gallizzi M, Gagnon C, Harden RN, Stanos S, Khan A. Medication quantification scale version III: internal validation of detriment weights using a chronic pain population. Pain Pract Off J World Inst Pain 2008;8:1-4.
Bendersky D, Yampolsky C. Is spinal cord stimulation safe? A review of its complications. World Neurosurg 2014;82:1359-1368.
North R, Desai MJ, Vangeneugden J et al. Postoperative infections associated with prolonged spinal cord stimulation trial duration (PROMISE RCT). Neuromodulation 2020;23:620-625.
North RB, Kidd DH, Olin JC, Sieracki JM. Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. Neurosurgery 2002 Aug;51:381-389. discussion 389-90.
Oakley JC, Espinosa F, Bothe H et al. Transverse tripolar spinal cord stimulation: results of an international multicenter study. Neuromodulation 2006;9:192-203.
Holsheimer J, Buitenweg JR. Review: bioelectrical mechanisms in spinal cord stimulation. Neuromodulation 2015;18:161-170. discussion 170.
Lee D, Gillespie E, Bradley K. Dorsal column steerability with dual parallel leads using dedicated power sources: a computational model. J Vis Exp 2011;2443
Rejc E, Angeli CA, Atkinson D, Harkema SJ. Motor recovery after activity-based training with spinal cord epidural stimulation in a chronic motor complete paraplegic. Sci Rep 2017;7:13476.
Wagner FB, Mignardot JB, Le Goff-Mignardot CG et al. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature 2018;563:65-71.
Koch GG. Discussion for: alpha calculus in clinical trials: considerations and commentary for the new millennium. Stat Med 2000;19:781-784.
Davis CE. Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance. Control Clin Trials 1997;18:557-560.
Guetarni F, The RP. Neuro-mapping locator software. A real-time intraoperative objective paraesthesia mapping tool to evaluate paraesthesia coverage of the painful zone in patients undergoing spinal cord stimulation lead implantation. Neurochirurgie 2015;61:S90-S98.