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Clinical Science| Volume 26, ISSUE 3, P666-675, April 2023

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Subcutaneous Stimulation as Add-on Therapy to Spinal Cord Stimulation in Patients With Persistent Spinal Pain Syndrome Significantly Increases the Total Electrical Charge per Second: Aspects on Stimulation Parameters and Energy Requirements of the Implanted Neurostimulators

      Abstract

      Objective

      In our previous multicenter randomized controlled trial, we demonstrated the clinical effectiveness of peripheral nerve field stimulation (PNFS) as add-on therapy to spinal cord stimulation (SCS) for the treatment of chronic back pain in patients with persistent spinal pain syndrome (PSPS) or failed back surgery syndrome (FBSS). To our knowledge, no previous study has investigated the effect of PNFS as an add-on to SCS on the energy consumption of the implanted neurostimulators. Therefore, in this study, we compared the specific stimulation parameters and energy requirements of a previously unreported group of patients with only SCS with those of a group of patients with SCS and add-on PNFS. We also investigated differences that might explain the need for PNFS in the treatment of chronic low back pain.

      Materials and Methods

      We analyzed 75 patients with complete sets of stimulation parameters, with 21 patients in the SCS-only group and 54 patients in the SCS + PNFS group. Outcome measures were average visual analog scale score, SCS parameters (voltage, frequency, and pulse width), SCS charge per second, and total charge per second. We analyzed baseline characteristics and differences between and within groups over time.

      Results

      Both groups had comparable patient characteristics at baseline and showed a significant decrease in back and leg pain. SCS charge per second did not significantly differ between the groups at baseline or at 12 months. The total charge per second was significantly higher in the active SCS + PNFS group than in the SCS-only group at baseline; in the SCS + PNFS group, this persisted for up to 12 months, and the SCS charge per second and total charge per second increased significantly over time.

      Conclusions

      Our results show that add-on PNFS increases the total charge per second compared with SCS alone, as expected. However, further research is needed because our results do not directly explain why some patients require add-on PNFS to treat low back pain.

      Keywords

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      References

        • Clancy C.
        • Quinn A.
        • Wilson F.
        The aetiologies of failed back surgery syndrome: a systematic review.
        J Back Musculoskelet Rehabil. 2017; 30: 395-402
        • Caylor J.
        • Reddy R.
        • Yin S.
        • et al.
        Spinal cord stimulation in chronic pain: evidence and theory for mechanisms of action.
        Bioelectron Med. 2019; 5: 12
        • Taylor R.S.
        • Desai M.J.
        • Rigoard P.
        • Taylor R.J.
        Predictors of pain relief following spinal cord stimulation in chronic back and leg pain and failed back surgery syndrome: a systematic review and meta-regression analysis.
        Pain Pract. 2014; 14: 489-505
        • Verrills P.
        • Sinclair C.
        • Barnard A.
        A review of spinal cord stimulation systems for chronic pain.
        J Pain Res. 2016; 9: 481-492
        • Grider J.S.
        • Manchikanti L.
        • Carayannopoulos A.
        • et al.
        Effectiveness of spinal cord stimulation in chronic spinal pain: a systematic review.
        Pain Physician. 2016; 19: E33-E54
        • Kumar K.
        • Taylor R.S.
        • Jacques L.
        • et al.
        Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome.
        Pain. 2007; 132: 179-188
        • North R.B.
        • Kidd D.H.
        • Farrokhi F.
        • Piantadosi S.A.
        Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial.
        Neurosurgery. 2005; 56 ([discussion: 106–107]): 98-106
        • Muhammad S.
        • Roeske S.
        • Chaudhry S.R.
        • Kinfe T.M.
        Burst or high-frequency (10 kHz) spinal cord stimulation in failed back surgery syndrome patients with predominant back pain: one year comparative data.
        Neuromodulation. 2017; 20: 661-667
        • Kapural L.
        • Cong Y.
        • Doust M.W.
        • 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: the SENZA-RCT randomized controlled trial.
        Anesthesiology. 2015; 123: 851-860
        • Metzger C.S.
        • Hammond M.B.
        • Pyles S.T.
        • et al.
        Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes.
        Expert Rev Med Devices. 2020; 17: 951-957https://doi.org/10.1080/17434440.2020.1812383
        • Mekhail N.
        • Levy R.M.
        • Deer T.R.
        • et al.
        Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.
        Lancet Neurol. 2020; 19: 123-134
        • Fishman M.
        • Cordner H.
        • Justiz R.
        • et al.
        Twelve-month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain.
        Pain Pract. 2021; 21: 912-923https://doi.org/10.1111/papr.13066
        • Van Gorp E.J.J.A.A.
        • Teernstra O.P.M.
        • Gültuna I.
        • et al.
        Subcutaneous stimulation as ADD-ON therapy to spinal cord stimulation is effective in treating low back pain in patients with failed back surgery syndrome: a multicenter randomized controlled trial.
        Neuromodulation. 2016; 19: 171-178
        • van Gorp E.J.J.A.A.
        • Teernstra O.
        • Aukes H.J.
        • et al.
        Long-term effect of peripheral nerve field stimulation as add-on therapy to spinal cord stimulation to treat low back pain in failed back surgery syndrome patients: a 12-month follow-up of a randomized controlled study.
        Neuromodulation. 2019; 22: 970-977
        • Melzack R.
        • Wall P.D.
        Pain mechanisms: a new theory.
        Science. 1965; 150: 971-979
        • Miller J.P.
        • Eldabe S.
        • Buchser E.
        • Johanek L.M.
        • Guan Y.
        • Linderoth B.
        Parameters of spinal cord stimulation and their role in electrical charge delivery: a review.
        Neuromodulation. 2016; 19: 373-384
        • Lee D.
        • Hershey B.
        • Bradley K.
        • Yearwood T.
        Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study.
        Med Biol Eng Comput. 2011; 49: 765-774
        • van Gorp E.J.J.A.A.
        • Adang E.M.M.
        • Gültuna I.
        • et al.
        Cost-effectiveness analysis of peripheral nerve field stimulation as add-on therapy to spinal cord stimulation in the treatment of chronic low back pain in failed back surgery syndrome patients.
        Neuromodulation. 2020; 23: 639-645
        • van Gorp E.J.
        • Eldabe S.
        • Slavin K.V.
        • et al.
        Peripheral nerve field stimulation for chronic back pain: therapy outcome predictive factors.
        Pain Pract. 2020; 20: 522-533
        • Hamm-Faber T.E.
        • Aukes H.
        • Van Gorp E.J.
        • Gültuna I.
        Subcutaneous stimulation as an additional therapy to spinal cord stimulation for the treatment of low back pain and leg pain in failed back surgery syndrome: four-year follow-up.
        Neuromodulation. 2015; 18: 618-622
        • Wille F.
        • Breel J.S.
        • Bakker E.W.P.
        • Hollmann M.W.
        Altering conventional to high density spinal cord stimulation: an energy dose-response relationship in neuropathic pain therapy.
        Neuromodulation. 2017; 20: 71-80
        • De Ridder D.
        • Vanneste S.
        • Plazier M.
        • Van Der Loo E.
        • Menovsky T.
        Burst spinal cord stimulation: toward paresthesia-free pain suppression.
        Neurosurgery. 2010; 66: 986-990
        • Meuwissen K.P.V.
        • Gu J.W.
        • Zhang T.C.
        • Joosten E.A.J.
        Conventional-SCS vs. burst-SCS and the behavioral effect on mechanical hypersensitivity in a rat model of chronic neuropathic pain: effect of amplitude.
        Neuromodulation. 2018; 21: 19-30
        • Ahmed S.
        • Yearwood T.
        • Ridder D.D.
        • Vanneste S.
        Burst and high frequency stimulation: underlying mechanism of action.
        Expert Rev Med Devices. 2018; 15: 61-70
        • Thomson S.J.
        • Tavakkolizadeh M.
        • Love-Jones S.
        • et al.
        Effects of rate on analgesia in kilohertz frequency spinal cord stimulation: results of the PROCO randomized controlled trial.
        Neuromodulation. 2018; 21: 67-76
        • Deer T.R.
        • Mekhail N.
        • Provenzano D.
        • et al.
        The appropriate use of neurostimulation: avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain. Neuromodulation Appropriateness Consensus Committee.
        Neuromodulation. 2014; 17 ([discussion: 597–598]): 571-597
        • Hayek S.M.
        • 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 ([discussion: 608–609]): 603-608
        • Kumar K.
        • Wilson J.R.
        • Taylor R.S.
        • Gupta S.
        Complications of spinal cord stimulation, suggestions to improve outcome, and financial impact.
        J Neurosurg Spine. 2006; 5: 191-203
        • Kumar K.
        • Nath R.
        • Wyant G.M.
        Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience.
        J Neurosurg. 1991; 75: 402-407
        • Celestin J.
        • Edwards R.R.
        • Jamison R.N.
        Pretreatment psychosocial variables as predictors of outcomes following lumbar surgery and spinal cord stimulation: a systematic review and literature synthesis.
        Pain Med. 2009; 10: 639-653
        • Brooker C.
        • Russo M.
        • Cousins M.J.
        • et al.
        ECAP-controlled closed-loop spinal cord stimulation efficacy and opioid reduction over 24-months: final results of the prospective, multicenter, open-label Avalon study.
        Pain Pract. 2021; 21: 680-691
        • Schultz D.M.
        • Webster L.
        • Kosek P.
        • Dar U.
        • Tan Y.
        • Sun M.
        Sensor-driven position-adaptive spinal cord stimulation for chronic pain.
        Pain Physician. 2012; 15: 1-12
        • Eldabe S.S.
        • Taylor R.S.
        • Goossens S.
        • et al.
        A randomized controlled trial of subcutaneous nerve stimulation for back pain due to failed back surgery syndrome: the SubQStim study.
        Neuromodulation. 2019; 22: 519-528
        • van Heteren E.P.Z.
        • van Roosendaal B.K.W.P.
        • van Gorp E.J.
        • et al.
        Spinal cord stimulation with additional peripheral nerve field stimulation versus spinal cord stimulation alone on back pain and quality of life in patients with failed back surgery syndrome.
        Neuromodulation. 2022;
        • Amirdelfan K.
        • Yu C.
        • Doust M.W.
        • et al.
        Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT.
        Qual Life Res. 2018; 27: 2035-2044
        • 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
        • Al-Kaisy A.
        • Palmisani S.
        • Smith T.E.
        • 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
        • Sayed D.
        • Kallewaard J.W.
        • Rotte A.
        • Jameson J.
        • Caraway D.
        Pain relief and improvement in quality of life with 10 kHz SCS therapy: summary of clinical evidence.
        CNS Neurosci Ther. 2020; 26: 403-415
        • Deer T.
        • Slavin K.V.
        • 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
        • Kirketeig T.
        • Schultheis C.
        • Zuidema X.
        • Hunter C.W.
        • Deer T.
        Burst spinal cord stimulation: a clinical review.
        Pain Med. 2019; 20: S31-S40
        • Chakravarthy K.
        • Malayil R.
        • Kirketeig T.
        • Deer T.
        Burst spinal cord stimulation: a systematic review and pooled analysis of real-world evidence and outcomes data.
        Pain Med. 2019; 20: S47-S57
        • North J.M.
        • Hong K.J.
        • Cho P.Y.
        Clinical outcomes of 1 kHz subperception spinal cord stimulation in implanted patients with failed paresthesia-based stimulation: results of a prospective randomized controlled trial.
        Neuromodulation. 2016; 19: 731-737
        • Holsheimer J.
        • Struijk J.J.
        • Tas N.R.
        Effects of electrode geometry and combination on nerve fibre selectivity in spinal cord stimulation.
        Med Biol Eng Comput. 1995; 33: 676-682
        • Paz-Solís J.
        • Thomson S.
        • Jain R.
        • Chen L.
        • Huertas I.
        • Doan Q.
        Exploration of high and low frequency options for subperception spinal cord stimulation using neural dosing parameter relationships: the HALO study.
        Neuromodulation. 2022; 25: 94-102