One-Year Results of Prospective Research Study Using 10 kHz Spinal Cord Stimulation in Persistent Nonoperated Low Back Pain of Neuropathic Origin: Maiden Back Study.
10 kHz
Allodynia
Hyperalgesia
non-operative back pain
spinal cord stimulation
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:
Apr 2021
Apr 2021
Historique:
revised:
24
11
2020
received:
11
09
2020
accepted:
25
11
2020
pubmed:
23
12
2020
medline:
19
8
2021
entrez:
22
12
2020
Statut:
ppublish
Résumé
Spinal cord stimulation (SCS) is a recommended treatment for chronic neuropathic pain. Persistent nonoperative low back pain of neuropathic origin has profound negative impacts on patient's lives. This prospective, open label, research study aimed to explore the use of SCS in patients with associated features of central sensitisation such as allodynia and hyperalgesia. Twenty-one patients with back pain and hyperalgesia or allodynia who had not had prior spinal surgery underwent a SCS trial followed by full implantation. SCS comprised administering electrical impulses epidurally at a frequency of 10 kHz and pulse width of 30 μsec. Patients attended follow-up visits after 6 and 12 months of SCS. Repeated measure ANOVAs/Friedman tests explored change after 6 and 12 months of 10 kHz SCS. Independent sample t-tests/Mann-Whitney U tests examined differences in response after 12 months of 10 kHz SCS. Back and leg pain, quality of life (QoL), pain-related disability, and morphine equivalence significantly improved compared with baseline following 6 and 12 months of 10 kHz SCS. There were no increases in the consumption of opioids, amitriptyline, gabapentin or pregabalin in any patient. After 12 months of treatment, 52% encountered ≥50% improvement in back pain, 44% achieved remission (0-3 cm back pain VAS), 40% reported ODI scores between 0 and 40 and 60% experienced a reduction of at least 10 ODI points. Patients reporting ≥10-point improvement in ODI had significantly longer pain history durations and experienced significantly greater improvements in back pain, leg pain and QoL than those reporting <10-point improvement in ODI. The 10 kHz SCS improved back and leg pain, QoL, pain-related disability and medication consumption in patients with nonoperative back pain of neuropathic origin. With further research incorporating a sham control arm, the efficacy of 10 kHz SCS in this patient cohort will become more established.
Identifiants
pubmed: 33351230
doi: 10.1111/ner.13345
pii: S1094-7159(21)00056-8
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
479-487Informations de copyright
© 2020 International Neuromodulation Society.
Références
Deer T, Slavin KV, Amirdelfan K et al. Success using Neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel Burst waveform. Neuromodulation 2018;21:56-66. https://doi.org/10.1111/ner.12698.
Duarte RV, Thomson S. Trial versus no trial of spinal cord stimulation for chronic neuropathic pain: cost analysis in United Kingdom National Health Service. Neuromodulation 2019;22:208-214. https://doi.org/10.1111/ner.12898.
Kapural L, Yu C, Doust MW et al. Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain. Anesthesiology 2015;123:851-860. https://doi.org/10.1097/ALN.0000000000000774.
Tiede J, Brown L, Gekht G, Vallejo R, Yearwood T, Morgan D. Novel spinal cord stimulation parameters in patients with predominant Back pain. Neuromodulation 2013;16:370-375. https://doi.org/10.1111/ner.12032.
Van Buyten J-P, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation 2013;16:59-66. https://doi.org/10.1111/ner.12006.
Russo M, Verrills P, Mitchell B, Salmon J, Barnard A, Santarelli D. High frequency spinal cord stimulation at 10 khz for the treatment of chronic pain: 6-month australian clinical experience. Pain Physician 2016;19:267-280.
Gupta M, Scowcroft J, Kloster D et al. 10-kHz spinal cord stimulation for chronic postsurgical pain: results from a 12-month prospective multicenter study. Pain Pract 2020;20:908-918. https://doi.org/10.1111/papr.12929.
Verrills P, Salmon J, Russo M, Gliner B, Barnard A, Caraway D. 10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience. Eur Spine J 2020;29:2786-2794. https://doi.org/10.1007/s00586-020-06480-x.
Amirdelfan K, Vallejo R, Benyamin R et al. High-frequency spinal cord stimulation at 10 kHz for the treatment of combined neck and arm pain: Results from a prospective multicenter study. Neurosurgery 2020;87:176-185. https://doi.org/10.1093/neuros/nyz495.
Sayed D, Foster J, Nairizi A, Sills S, Miller A. 10 kHz high-frequency spinal cord stimulation for chronic thoracic pain: a multicenter case series and a guide for optimal anatomic lead placement. Pain Physician 2020;23:E369-E376.
Kapural L, Gupta M, Paicius R et al. Treatment of chronic abdominal pain with 10-kHz spinal cord stimulation. Clin Transl Gastroenterol 2020;11:e00133. https://doi.org/10.14309/ctg.0000000000000133.
Telkes L, Hancu M, Paniccioli S et al. Differences in EEG patterns between tonic and high frequency spinal cord stimulation in chronic pain patients. Clin Neurophysiol 2020;131:1731-1740. https://doi.org/10.1016/j.clinph.2020.03.040.
Al-Kaisy A, Van Buyten J-P, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low Back pain: 24-month results of a prospective multicenter study. Pain Med 2014;15:347-354. https://doi.org/10.1111/pme.12294.
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. Neurosurgery 2016;79:667-677. https://doi.org/10.1227/NEU.0000000000001418.
Al-Kaisy A, Palmisani S, Smith TE et al. Long-term improvements in chronic axial low back pain patients without previous spinal surgery: a cohort analysis of 10-kHz high-frequency spinal cord stimulation over 36 months. Pain Med 2018;19:1219-1226. https://doi.org/10.1093/pm/pnx237.
Kapural L, Yu C, Doust MW et al. Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord. Anesthesiology 2015;123:851-860.
Tate JL, Stauss T, Li S, Rotte A, Subbaroyan J. A prospective, multi-center, clinical trial of a 10-kHz spinal cord stimulation system in the treatment of chronic pelvic pain. Pain Pract 2020. https://doi.org/10.1111/papr.12932.
Hooten WM. Chronic pain and mental health disorders. Mayo Clin Proc 2016;91:955-970. https://doi.org/10.1016/j.mayocp.2016.04.029.
Gupta M, Abd-Elsayed A, Knezevic NN. Improving care of chronic pain patients with spinal cord stimulator therapy amidst the opioid epidemic. Neurol Sci 2020;41:2703-2710. https://doi.org/10.1007/s10072-020-04435-0.
Al-Kaisy A, Van Buyten J, Amirdelfan K et al. Opioid-sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence. Ann N Y Acad Sci 2020;1462:53-64. https://doi.org/10.1111/nyas.14236.
Rapcan R, Mlaka J, Venglarcik M, Vinklerova V, Gajdos M, Illes R. High-frequency - Spinal cord stimulation. Bratislava Med J 2015;116:354-356. https://doi.org/10.4149/BLL_2015_067.
Stauss T, El Majdoub F, Sayed D et al. A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain. Ann Clin Transl Neurol 2019;6:496-507. https://doi.org/10.1002/acn3.720.
Wilding R, Barnes S, Chincholkar M, Lalkhen A. Invited faculty abstracts from the international Neuromodulation Society's 14th world congress. Neuromodulation 2019;22:e358. https://doi.org/10.1111/ner.12958.
Al-Kaisy A, Palmisani S, Smith TE et al. 10 kHz high-frequency spinal cord stimulation for chronic axial low Back pain in patients with no history of spinal surgery: a preliminary, prospective, open label and proof-of-concept study. Neuromodulation 2017;20:63-70. https://doi.org/10.1111/ner.12563.
Salmon J. High-frequency spinal cord stimulation at 10 kHz for widespread pain: a retrospective survey of outcomes from combined cervical and thoracic electrode placements. Postgrad Med 2019;131:230-238. https://doi.org/10.1080/00325481.2019.1587564.
Al-Kaisy A, Van Buyten J-P, Carganillo R et al. 10 kHz SCS therapy for chronic pain, effects on opioid usage: post hoc analysis of data from two prospective studies. Sci Rep 2019;9:11441. https://doi.org/10.1038/s41598-019-47792-3.
DiBenedetto DJ, Wawrzyniak KM, Schatman ME, Kulich RJ, Finkelman M. 10 kHz spinal cord stimulation: a retrospective analysis of real-world data from a community-based, interdisciplinary pain facility. J Pain Res 2018;11:2929-2941. https://doi.org/10.2147/JPR.S188795.
Gee L, Smith HC, Ghulam-Jelani Z et al. Spinal cord stimulation for the treatment of chronic pain reduces opioid use and results in superior clinical outcomes when used without opioids. Neurosurgery 2019;84:217-226. https://doi.org/10.1093/neuros/nyy065.
Al-Kaisy A, Van Buyten JP, Kapural L et al. 10 kHz spinal cord stimulation for the treatment of non-surgical refractory back pain: subanalysis of pooled data from two prospective studies. Anaesthesia 2020;75:775-784. https://doi.org/10.1111/anae.15036.
Ostelo RWJG, Deyo RA, Stratford P et al. Interpreting change scores for pain and functional status in low back pain. Spine (Phila Pa 1976) 2008;33:90-94. https://doi.org/10.1097/BRS.0b013e31815e3a10.
Deckers K, De Smedt K, Mitchell B et al. New therapy for refractory chronic mechanical low back pain-Restorative Neurostimulation to activate the lumbar Multifidus: one year results of a prospective multicenter clinical trial. Neuromodulation. 2018;21:48-55. https://doi.org/10.1111/ner.12741.
Aoyagi K, He J, Nicol AL et al. A subgroup of chronic low back pain patients with central sensitization. Clin J Pain 2019;35:869-879. https://doi.org/10.1097/AJP.0000000000000755.
Vallejo R, de Leon-Casasola O, Benyamin R. Opioid therapy and immunosuppression. Am J Ther 2004;11:354-365. https://doi.org/10.1097/01.mjt.0000132250.95650.85.
Sacerdote P. Opioid-induced immunosuppression. Curr Opin Support Palliat Care 2008;2:14-18. https://doi.org/10.1097/SPC.0b013e3282f5272e.
De Jaeger M, Goudman L, Eldabe S, Van Dongen R, De Smedt A, Moens M. The association between pain intensity and disability in patients with failed back surgery syndrome, treated with spinal cord stimulation. Disabil Rehabil 2019;1-7. https://doi.org/10.1080/09638288.2019.1694084.
Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Control Clin Trials 1989;10:407-415. https://doi.org/10.1016/0197-2456(89)90005-6.
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain 2000;88:287-294. https://doi.org/10.1016/S0304-3959(00)00339-0.
Farrar JT, Pritchett YL, Robinson M, Prakash A, Chappell A. The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. J Pain 2010;11:109-118. https://doi.org/10.1016/j.jpain.2009.06.007.
Farrar JT. What is clinically meaningful: outcome measures in pain clinical trials. Clin J Pain 2000;16:S106-S112. https://doi.org/10.1097/00002508-200006001-00018.
Farrar JT, Young JP, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94:149-158. https://doi.org/10.1016/S0304-3959(01)00349-9.
Eldabe S, Duarte RV, Gulve A et al. Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? A randomised controlled trial. Pain 2020;161:2820-2829. https://doi.org/10.1097/j.pain.0000000000001977.
Hayek SM, Veizi E, Hanes M. Treatment-limiting complications of percutaneous spinal cord stimulator implants: a review of eight years of experience from an academic center database. Neuromodulation 2015;18:603-609. https://doi.org/10.1111/ner.12312.
Manca A, Kumar K, Taylor RS et al. Quality of life, resource consumption and costs of spinal cord stimulation versus conventional medical management in neuropathic pain patients with failed back surgery syndrome (PROCESS trial). Eur J Pain 2008;12:1047-1058. https://doi.org/10.1016/j.ejpain.2008.01.014.
Pope JE, Deer TR, Falowski S et al. Multicenter retrospective study of neurostimulation with exit of therapy by explant. Neuromodulation 2017;20:543-552. https://doi.org/10.1111/ner.12634.