Clark S Metzger1, M Blake Hammond1, Stephen T Pyles2, Edward P Washabaugh3, Romanth Waghmarae4, Anthony P Berg5, James M North6, Yu Pei7, Roshini Jain7. 1. NeuroMicroSpine , Pensacola, FL, USA. 2. Pain Treatment Centers , Ocala, FL, USA. 3. Forest Health Medical Center , Ypsilanti, MI, USA. 4. Advanced Pain and Wellness Institute , Williamsville, NY, USA. 5. Spine Team Texas , Rockwall, TX, USA. 6. The Center for Clinical Research, LLC , Winston-Salem, NC, USA. 7. Division of Neuromodulation, Boston Scientific , Valencia, CA, USA.
Abstract
BACKGROUND: Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction. RESEARCH DESIGN AND METHODS: This case-series evaluated 420 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of neurostimulation (i.e. combination therapy) as well as multiple waveforms and/or field shapes. Following implantation, an array of standard programs (e.g. paresthesia-based SCS), and a custom set of sub-perception programs were provided per patient feedback. Pain scores (Numeric Rating Scale, NRS) were collected at baseline and during follow-up. RESULTS: In this multicenter, observational series (n = 420, 53.1% female; Age: 64.2 ± 13.4 years), a mean overall pain score of 7.2 ± 1.8 (SD) was reported pre-trial (Baseline). At a mean follow-up duration of 208 ± 200 (SD) days, the mean overall pain score reduced to 2.4 (p < 0.0001). Overall pain was reduced by 5.1 ± 2.4 and 4.5 ± 2.4 points (NRS) at 3-months (N = 256) and at 12-months post-implant (N = 122) respectively (p < 0.0001). CONCLUSIONS: These results suggest that highly 'customizable' SCS approaches may allow for highly effective pain relief within the real-world clinical setting.
BACKGROUND: Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatment effectiveness and satisfaction. RESEARCH DESIGN AND METHODS: This case-series evaluated 420 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of neurostimulation (i.e. combination therapy) as well as multiple waveforms and/or field shapes. Following implantation, an array of standard programs (e.g. paresthesia-based SCS), and a custom set of sub-perception programs were provided per patient feedback. Pain scores (Numeric Rating Scale, NRS) were collected at baseline and during follow-up. RESULTS: In this multicenter, observational series (n = 420, 53.1% female; Age: 64.2 ± 13.4 years), a mean overall pain score of 7.2 ± 1.8 (SD) was reported pre-trial (Baseline). At a mean follow-up duration of 208 ± 200 (SD) days, the mean overall pain score reduced to 2.4 (p < 0.0001). Overall pain was reduced by 5.1 ± 2.4 and 4.5 ± 2.4 points (NRS) at 3-months (N = 256) and at 12-months post-implant (N = 122) respectively (p < 0.0001). CONCLUSIONS: These results suggest that highly 'customizable' SCS approaches may allow for highly effective pain relief within the real-world clinical setting.
Authors: Jan Willem Kallewaard; Jose Francisco Paz-Solis; Pasquale De Negri; Maria Angeles Canós-Verdecho; Hayat Belaid; Simon J Thomson; David Abejón; Jan Vesper; Vivek Mehta; Philippe Rigoard; Paolo Maino; Sarah Love-Jones; Isaac F Peña; Simon Bayerl; Christophe Perruchoud; Renaud Bougeard; Cleo Mertz; Yu Pei; Roshini Jain Journal: J Clin Med Date: 2021-09-10 Impact factor: 4.964
Authors: Amnon A Berger; Ivan Urits; Jamal Hasoon; Jatinder Gill; Musa Aner; Cyrus A Yazdi; Omar Viswanath; Elyse M Cornett; Alan David Kaye; Farnad Imani; Farsad Imani; Giustino Varrassi; Thomas T Simopoulos Journal: Anesth Pain Med Date: 2021-02-22