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Ho T, O'Brien M, Sullivan R, Standen J, Weiss ADH, Bates D, Salmon J, Christelis N, Yu J, Taverner M, Russo M. Best Practice Guidelines for Neuromodulation in Pain Management: Insight From the Neuromodulation Society of Australia and New Zealand. Neuromodulation 2025:S1094-7159(25)00145-X. [PMID: 40434331 DOI: 10.1016/j.neurom.2025.03.080] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2025] [Revised: 03/30/2025] [Accepted: 03/30/2025] [Indexed: 05/29/2025]
Abstract
OBJECTIVES The Neuromodulation Society of Australia and New Zealand (NSANZ) developed evidence-based best practice guidelines for spinal cord stimulation (SCS) in chronic pain management. The primary objective was to provide clear guidance to support evidence-informed care across Australia and New Zealand, with a focus on patient selection, procedural techniques, and complication management. MATERIALS AND METHODS A systematic literature review was conducted using Medline, EMBASE, Trip Pro, and Google Scholar, covering publications from 2010 to July 2024. A total of 283 studies and relevant clinical guidelines were included on the basis of level 1B evidence or strong expert consensus, consistent with the Grading of Recommendations Assessment, Development, and Evaluation criteria. Clinical questions were developed using the Population, Intervention, Comparison, and Outcome framework, and a Delphi process was used to achieve consensus among NSANZ board members. RESULTS The guidelines provide comprehensive recommendations on patient selection, preparation, procedural techniques, postimplantation care, and complication management. Additional guidance is included on training standards, quality improvement processes, and the importance of multidisciplinary collaboration. Key recommendations emphasize optimizing patient selection, enhancing procedural safety, and improving treatment outcomes. CONCLUSIONS These guidelines offer practical, evidence-informed recommendations for the safe and effective use of SCS in chronic pain management. By promoting consistency, transparency, and collaborative care, they aim to guide clinical decision-making and support the delivery of evidence-informed neuromodulation services across Australia and New Zealand.
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Affiliation(s)
- Tim Ho
- Sydney Medical School, Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
| | - Michelle O'Brien
- Specialists in Pain, St. Vincent's Private Hospital Brisbane, Brisbane, Australia
| | | | - Jane Standen
- Sydney Medical School, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Andrew D H Weiss
- Sydney Medical School, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia
| | - Dan Bates
- Metro Pain Group, Victoria, Australia
| | - John Salmon
- Pain Management, Pain Care Perth, Cottesloe, Australia
| | | | - James Yu
- Pain Medicine, Australian Medical Research, Sydney, Australia
| | - Murray Taverner
- Department of Pain Management, Frankston Pain Management, Melbourne, Australia
| | - Marc Russo
- Hunter Pain Clinic, Broadmeadow, Australia
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Mangano N, Torpey A, Devitt C, Wen GA, Doh C, Gupta A. Closed-Loop Spinal Cord Stimulation in Chronic Pain Management: Mechanisms, Clinical Evidence, and Emerging Perspectives. Biomedicines 2025; 13:1091. [PMID: 40426918 PMCID: PMC12108722 DOI: 10.3390/biomedicines13051091] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2025] [Revised: 04/20/2025] [Accepted: 04/26/2025] [Indexed: 05/29/2025] Open
Abstract
Background: Chronic pain remains a major clinical challenge, which is often resistant to conventional treatments. Spinal cord stimulation has been used for decades to manage refractory pain, traditionally relying on open-loop systems with fixed-output stimulation. However, these systems fail to account for physiological variability, leading to inconsistent pain relief. Closed-loop spinal cord stimulation represents a significant advancement by utilizing evoked compound action potentials to continuously modulate stimulation intensity in real-time, ensuring more stable and effective pain management. Methods: A comprehensive literature review was conducted using PubMed and ClinicalTrials.gov to identify and synthesize relevant published and ongoing studies with a focus on open-loop spinal cord stimulation for managing lower back pain. Results: Clinical trials, including the Avalon and Evoke studies, have demonstrated that closed-loop spinal cord stimulation provides superior pain relief, functional improvement, and reduced opioid dependence compared to traditional open-loop systems. Patients receiving closed-loop stimulation reported significantly higher rates of sustained pain reduction, improved quality of life, and fewer complications related to overstimulation. Emerging studies suggest its potential for conditions beyond back pain, such as neuropathic pain, cancer-related pain, and Raynaud's phenomenon. Furthermore, cost-effectiveness analyses indicate that closed-loop spinal cord stimulation is a more economically viable treatment option compared to conventional medical management and open-loop systems. Conclusions: Closed-loop spinal cord stimulation represents a transformative development in neuromodulation, offering personalized and adaptive pain management that is distinct from open-loop spinal cord stimulation. Further research is warranted to explore its long-term durability, broader applications, and integration with emerging technologies in pain management.
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Affiliation(s)
- Nicholas Mangano
- Department of Anesthesiology, Stony Brook Medicine, 101 Nicolls Road, Stony Brook, New York, NY 11794, USA
| | - Andrew Torpey
- Department of Anesthesiology, Stony Brook Medicine, 101 Nicolls Road, Stony Brook, New York, NY 11794, USA
| | - Catherine Devitt
- Department of Anesthesiology, Stony Brook Medicine, 101 Nicolls Road, Stony Brook, New York, NY 11794, USA
| | - George A. Wen
- Renaissance School of Medicine, Stony Brook University, 101 Nicolls Road, Stony Brook, New York, NY 11794, USA
| | - Christopher Doh
- Department of Anesthesiology, Division of Chronic Pain, Stony Brook Medicine, 101 Nicolls Road, Stony Brook, New York, NY 11794, USA
| | - Abhishek Gupta
- Department of Anesthesiology, Division of Chronic Pain, Stony Brook Medicine, 101 Nicolls Road, Stony Brook, New York, NY 11794, USA
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Reining M, Winkler D, Kirchhof K, Boettcher J, Kretzschmar M. Effects of an extended MRI approval of an implantable spinal cord stimulation device on compliance with manufacturer's recommendations. Pain Pract 2025; 25:e70022. [PMID: 40159636 DOI: 10.1111/papr.70022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/02/2025]
Abstract
OBJECTIVE The current approval for all available spinal cord stimulation (SCS) devices set several limitations for magnetic resonance imaging (MRI). As a result, most of the necessary examinations are not possible within the scope of the restrictive approvals and, if legally permitted, must be carried out off-label. This retrospective subgroup analysis investigates if the currently extended MRI approval of one specific device allows more MRI scans to be conducted within the manufacturer's recommendations. MATERIALS AND METHODS Technical MRI data (saved in the DICOM headers) and medical treatment data for all MRI examinations on patients with Proclaim® implantable pulse generators (IPG; Proclaim® spinal cord stimulation systems, Abbott Laboratories, Plano, TX, USA) were examined. Due to a major change in our standard operating procedures for MRI scans in 2019, the two time periods (before and after 2019) were separately analyzed. RESULTS We identified 62 MRI scans with the IPG. The entire implanted system was approved for MRI examinations in just over 50% of the cases, regardless of old and new approval. Options for lead placement were expanded in the new approval; however, this did not significantly improve the number of MR conditional devices. By contrast, for a higher specific absorption rate, significantly more scans within the recommendations are possible in Period 2 (p = 0.011). However, the number of possible scans did not reach statistical significance in Period 1 (p = 0.078). No device-related adverse events were noted. CONCLUSION The new MRI approval is suitable for performing more scans within the manufacturer's specifications. Cervical leads remain problematic because longer leads are required, and the lower impedances inhibit the MRI mode.
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Affiliation(s)
- Marco Reining
- Department of Pain Medicine and Palliative Care, SRH Wald-Klinikum Gera GmbH, Gera, Germany
- SRH Mobile University, Riedlingen, Germany
| | - Dirk Winkler
- Department of Neurosurgery, University Hospital Leipzig, Leipzig, Germany
| | - Klaus Kirchhof
- Department of Diagnostic and Interventional Radiology, SRH Wald-Klinikum Gera GmbH, Gera, Germany
| | | | - Michael Kretzschmar
- Department of Pain Medicine and Palliative Care, SRH Wald-Klinikum Gera GmbH, Gera, Germany
- SRH University of Applied Sciences Heidelberg, Heidelberg, Germany
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Wahezi SE, Yener U, Naeimi T, Lewis JB, Yerra S, Sgobba P, Ciftci HB, Vydyanathan A, Chiu E, Cherkalin D, Darji JY, Masterson R, Lee D, Jarusriwanna A, Palee S, Ortiz NR, Caparo M, Dayon E, Fontaine C, Bikson M, Schatman ME, Pritzlaff SG, Deer TR, Hunter CW. Spinal Cord Stimulation Explantation and Chronic Pain: A Systematic Review and Technology Recommendations. J Pain Res 2025; 18:1327-1340. [PMID: 40124536 PMCID: PMC11929510 DOI: 10.2147/jpr.s514732] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2025] [Accepted: 03/11/2025] [Indexed: 03/25/2025] Open
Abstract
Background Chronic pain affects 20.5% of the US population, costing $296 billion annually in lost productivity. Spinal cord stimulation (SCS) has become a key treatment for refractory neuropathic and nociceptive pain, with increasing usage due to technological advancements. However, the durability of SCS therapy, including explantation rates, remains a concern. Understanding explantation causes is essential for improving patient selection and device effectiveness. This study aims to analyze SCS explantation rates and reasons, as well as evaluate the financial burden of these procedures on the healthcare system. Methods Three primary screening methods were used: manual search with keywords, MeSH term query, and reference list screening. The search covered PubMed, Cochrane, and Web of Science databases from inception to November 2024, yielding 719 articles. After applying eligibility criteria, 72 articles were identified, and 25 were selected for analysis. Data extraction was done by independent reviewers, with a second reviewer ensuring accuracy. Discrepancies were resolved by the corresponding editor. Results We reviewed data from 13,026 patients who underwent permanent SCS implantation between 1984 and 2024, across 25 studies. A total of 1882 patients (9.82%) underwent explantation. The most common reason was lack of efficacy and inadequate pain relief (38%), followed by lead failure (15%) and infection (14%). While SCS is generally effective, issues related to device longevity and patient satisfaction persist, with explantation rates due to technical failures and lack of efficacy being concerns. Conclusion SCS efficacy varies, with explantation rates reaching up to 38%, often due to inadequate pain relief. Most explantations occur within the first year, despite SCS being a safe and effective treatment. High implantation costs ($35,000 to $70,000) and revision costs ($15,000 to $25,000) raise concerns among payors. The hardware-driven model limits waveform flexibility, highlighting the need for innovation.
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Affiliation(s)
- Sayed E Wahezi
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Ugur Yener
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Tahereh Naeimi
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Joshua B Lewis
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Sandeep Yerra
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Philip Sgobba
- Department of Anesthesiology, Montefiore Medical Center, Bronx, NY, USA
| | - Hatice Begum Ciftci
- Physical Medicine and Rehabilitation, ROMMER International Physical Therapy and Rehabilitation Medical Center, Bursa, Turkey
| | | | - Elisa Chiu
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Denis Cherkalin
- Pain Management, New York Spine Specialist, New York, NY, USA
| | - Jay Y Darji
- Pain Management, Regenerative Spine and Pain Institute, Plainsboro Township, NJ, USA
| | - Ryan Masterson
- Pain Management, Old Mill District Clinic, Summit Health, Bend, OR, USA
| | - Danielle Lee
- Department of Neurology, Hackensack University Medical Center, Hackensack, NJ, USA
| | - Atthakorn Jarusriwanna
- Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand
| | - Suwannika Palee
- Department of Rehabilitation Medicine, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand
| | - Nicole R Ortiz
- Pain Management, Sage Pain & Wellness Institute, San Diego, CA, USA
| | - Moorice Caparo
- Department of Physical Medicine & Rehabilitation, Montefiore Medical Center, Bronx, NY, USA
| | - Eli Dayon
- Department of Physical Medicine & Rehabilitation, Burke Rehabilitation Hospital, White Plains, NY, USA
| | - Camille Fontaine
- Department of Anesthesiology, Montefiore Medical Center, Bronx, NY, USA
| | - Marom Bikson
- Department of Biomedical Engineering, the City College of New York, New York, NY, USA
| | - Michael E Schatman
- Department of Anesthesiology, Perioperative Care and Pain Medicine, Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, NY, USA
| | - Scott G Pritzlaff
- Department of Anesthesiology and Pain Medicine, University of California, Davis, CA, USA
| | - Timothy R Deer
- The Spine and Nerve Center of the Virginias, West Virginia University Hospitals, Charleston, WV, USA
| | - Corey W Hunter
- Ainsworth Institute of Pain Management, Department of Rehabilitation & Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, USA
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Hoffmann C, Fautsch KJ, D'Souza RS. Incidence of Lead Tip Fracture and Retention After Percutaneous Lead Implantation for Peripheral Nerve Stimulation With an External Pulse Generator: A Multicenter Comparative Analysis of 456 Lead Implants Across Two Lead Hardware Generations. Neuromodulation 2025:S1094-7159(25)00022-4. [PMID: 39955665 DOI: 10.1016/j.neurom.2025.01.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 01/12/2025] [Accepted: 01/20/2025] [Indexed: 02/17/2025]
Abstract
OBJECTIVES Lead fracture and retention are potential adverse events that can occur after peripheral nerve stimulator (PNS) lead implantation, although recent technologic advancements in PNS hardware have been implemented to avert this risk. We aim to quantify the current incidence of temporary PNS lead fracture/retention and compare this with rates before changes in lead hardware design of temporary PNS. MATERIALS AND METHODS A multicenter, retrospective observational study was conducted for patients implanted with a temporary PNS system (SPR© Therapeutics, Cleveland, OH) between June 1, 2018 and August 1, 2024. Patients were included if they underwent a temporary percutaneous PNS system implantation with planned lead removal at 60 days. Patients were excluded if there was ambiguity regarding the status of the lead tip at time of removal (intact vs fractured) or if there was inadvertent lead removal by the patient during the 60-day treatment. The primary objectives of this study were 1) to quantify the incidence of lead retention with removal of temporary percutaneous PNS and 2) to compare the rates of lead retention in the original lead design (version 1.0) and the revised lead design (version 2.0). Secondary objectives included analysis of lead retention rates based on the following covariates: body mass index (BMI), patient age, location of lead placement, or duration of lead implant. RESULTS Within the studied timeframe, 337 patients were implanted with a total of 456 leads. Of 337 patients, 40.4% (n = 136) were implanted with lead version 1.0, and 59.6% (n = 201) were implanted with lead version 2.0. Overall, 7.5% of implanted leads (34/456) were retained, affecting 10.1% of patients. Of 194 implanted version 1.0 leads, 13.4% of leads (n = 26) were retained, whereas of 262 version 2.0 leads, 3.1% (n = 8) were retained (p < 0.001). These results showed a reduction in retained leads per patient from 19.1% with lead version 1.0 to 4.0% with revised lead version 2.0. Covariates including BMI, patient age, location of lead placement, or duration of lead implant did not predict lead retention rates. CONCLUSIONS Retention and fracture of temporary PNS leads remain prevalent, affecting 7.5% of all implanted leads, although we also observed a significant decrease in rates (3.1% vs 13.4%) with implementation of the revised lead version 2.0 hardware design.
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Affiliation(s)
- Chelsey Hoffmann
- Division of Pain Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA
| | - Kalli J Fautsch
- Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA
| | - Ryan S D'Souza
- Division of Pain Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.
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Mehta V, Munglani R, Eyre G, Bajaj G, Abd-Elsayed A, Poply K. Consenting for Spinal Cord Stimulation - the Pitfalls and Solution. Curr Pain Headache Rep 2025; 29:44. [PMID: 39891805 PMCID: PMC11787249 DOI: 10.1007/s11916-024-01349-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/30/2024] [Indexed: 02/03/2025]
Abstract
PURPOSE OF REVIEW To discuss the importance of the consenting process for patients undergoing spinal cord stimulation (SCS) therapy and understanding related complications and effects. RECENT FINDINGS Litigation for SCS/DRG related complications can be very costly, with the mean average settlement in cases relating to SCS being $303,173 dollars in the USA. According to the US Anaesthesia Closed Claims Project database, 10,546 claims related to pain medicine were made between 1990 and 2013; 43 of which were associated with SCS complications. This article will further explore consenting and complications within the context of SCS. Consenting for SCS is a crucial and very important step which potentially reflect on patients' expectations and outcomes.
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Affiliation(s)
- Vivek Mehta
- Barts Health NHS Trust, Pain Research Centre, London, UK
| | | | | | - Gaurav Bajaj
- Barts Health NHS Trust, Pain Research Centre, London, UK
| | | | - Kavita Poply
- Barts Health NHS Trust, Pain Research Centre, London, UK.
- Queen Mary University, London, UK.
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7
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Russo MA, Volschenk W, Bailey D, Santarelli DM, Holliday E, Barker D, Dizon J, Graham B. Twelve-Month Clinical Trial Results of a Novel, Dorsal Horn Dendrite Stimulation Waveform for Chronic Neuropathic Low Back Pain. Neuromodulation 2025; 28:263-273. [PMID: 39436334 DOI: 10.1016/j.neurom.2024.09.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2024] [Revised: 09/16/2024] [Accepted: 09/21/2024] [Indexed: 10/23/2024]
Abstract
OBJECTIVES The aim of this study was to evaluate the effectiveness and safety of a novel subperception spinal cord stimulation (SCS) waveform paradigm designed to target the dorsal horn dendrites for treating chronic neuropathic low back pain (LBP). The final 12-month results are reported here. MATERIALS AND METHODS Twenty-seven participants were implanted with a commercial SCS system. Devices were programmed to deliver the waveform (frequency 100 Hz, pulse width 1000 μsec, T9-T10 disk bipole) at decreasing stimulation perception threshold amplitudes (80%, 60%, then 40%) over a 14-week period. Participants were blinded to the program settings. Participants then received their preferred program for further evaluation at 26 and 52 weeks after activation. Outcome measures included back pain score (visual analogue scale [VAS]), Brief Pain Inventory (BPI), EuroQol 5-Dimension 5-Level (EQ-5D-5L), 36-Item Short Form Health Survey (SF-36), treatment satisfaction, and clinician global impression of change (CGIC). RESULTS At 52 weeks (n = 24), the responder rate (≥50% pain relief) was 65.6%, and the high-responder rate (≥80% pain relief) was 56.5%. The mean change from baseline in pain VAS was -43.94 mm (95% CI -57.89, -30.00; p < 0.001) and mean pain relief was 64.69% ± 39.43%. BPI and SF-36 scores remained significantly improved (p ≤ 0.001). EQ-5D-5L index and EuroQoL-VAS further improved, and 87.0% of participants met the minimum clinically important difference for the EQ-5D-5L index. Treatment satisfaction was 83%, and 91% of participants had a CGIC rating of "much improved" or above. No serious study-related adverse events were reported. CONCLUSIONS The 12-month trial results show sustained improvements in pain, quality of life, and health-related outcomes. This novel subperception dorsal horn dendrite SCS approach seems a safe and promising treatment option for patients with chronic neuropathic LBP. The open-source availability of this waveform on commercial SCS platforms allows widespread patient access. Further evaluation seems warranted. CLINICAL TRIAL REGISTRATION The Clinicaltrials.gov registration number for the study is ACTRN12618000647235 (anzctr.org.au).
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Affiliation(s)
- Marc A Russo
- Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia; School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
| | - Willem Volschenk
- Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia
| | - Dominic Bailey
- Genesis Research Services, Broadmeadow, New South Wales, Australia
| | | | - Elizabeth Holliday
- Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia; School of Medicine and Public Health, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia
| | - Daniel Barker
- Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
| | - Jason Dizon
- Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
| | - Brett Graham
- School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
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Gazzeri R, Mosca J, Occhigrossi F, Mercieri M, Galarza M, Leoni MLG. Spinal Cord Stimulation for Refractory Angina Pectoris: Current Status and Future Perspectives, a Narrative Review. J Cardiovasc Dev Dis 2025; 12:33. [PMID: 39852311 PMCID: PMC11766387 DOI: 10.3390/jcdd12010033] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2024] [Revised: 01/07/2025] [Accepted: 01/14/2025] [Indexed: 01/26/2025] Open
Abstract
Refractory angina pectoris (RAP) is a clinical syndrome characterized by persistent chest pain caused by myocardial ischemia that is unresponsive to optimal pharmacological therapy and revascularization procedures. Spinal cord stimulation (SCS) has emerged as a promising therapeutic option for managing RAP, offering significant symptom relief and improved quality of life. A systematic literature review was conducted to evaluate the clinical effectiveness, mechanisms of action, and safety profile of SCS in treating RAP. Comprehensive searches were performed in PubMed, Scopus, and Web of Science for studies published between 1990 and 2023. Of 328 articles identified, 6 met the inclusion and exclusion criteria for final analysis. The included studies consistently demonstrated that SCS significantly reduces the frequency of anginal episodes and nitroglycerin use while improving exercise capacity and quality of life. Proposed mechanisms include modulation of pain signals via the gate control theory, enhancement of autonomic balance, and redistribution of myocardial perfusion. Novel stimulation modalities, including high-frequency, Burst, and Differential Target Multiplexed (DTM), show potential advantages in enhancing patient comfort and clinical outcomes. Nevertheless, long-term studies are necessary to validate these findings and establish the comparative efficacy of these advanced technologies. SCS is a safe and effective therapy for patients with RAP who are unsuitable for surgical interventions. Innovations in neurostimulation, including closed-loop systems and personalized treatment strategies have the potential to further optimize outcomes. Rigorous clinical trials are needed to consolidate the role of SCS as a cornerstone therapy for the management of RAP.
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Affiliation(s)
- Roberto Gazzeri
- Interventional and Surgical Pain Management Unit, San Giovanni–Addolorata Hospital, 00184 Rome, Italy
| | - Jacopo Mosca
- Department of Anesthesiology, Critical Care and Pain Medicine, La Sapienza University of Rome, 00185 Rome, Italy
| | - Felice Occhigrossi
- Interventional and Surgical Pain Management Unit, San Giovanni–Addolorata Hospital, 00184 Rome, Italy
| | - Marco Mercieri
- Department of Medical and Surgical Sciences and Translational Medicine, Sapienza University of Rome, 00185 Rome, Italy
| | - Marcelo Galarza
- Regional Service of Neurosurgery, “Virgen de la Arrixaca” University Hospital, 30120 Murcia, Spain
| | - Matteo Luigi Giuseppe Leoni
- Department of Medical and Surgical Sciences and Translational Medicine, Sapienza University of Rome, 00185 Rome, Italy
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9
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Naidu RK, Kapural L, Li S, Tourjé C, Rutledge J, Dickerson D, Lubenow TR. A Review of the Prospera Spinal Cord Stimulation System with Multiphase Stimulation and Proactive Care. Curr Pain Headache Rep 2025; 29:25. [PMID: 39804395 PMCID: PMC11729204 DOI: 10.1007/s11916-024-01318-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/31/2024] [Indexed: 01/16/2025]
Abstract
PURPOSE OF REVIEW The purpose of this review is to describe the development and key features of the Prospera™ Spinal Cord Stimulation (SCS) System, as well as the clinical evidence supporting its use. Prospera delivers therapy using a proprietary multiphase stimulation paradigm and is the first SCS system to offer proactive care through automatic, objective, daily, remote device monitoring and remote programming capabilities. RECENT FINDINGS Results from the recently published BENEFIT-02 trial support the short-term safety and efficacy of multiphase stimulation in patients with chronic pain. BENEFIT-03 is an ongoing, multicenter, single-arm study with 24-month follow-up; interim analyses suggest that multiphase therapy is safe and effective and that patients and clinicians have positive experiences with remote device management. Preliminary evidence suggests that the Prospera SCS System represents an opportunity to improve patient care by combining an effective multiphase stimulation paradigm with an efficient proactive care model.
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Affiliation(s)
- Ramana K Naidu
- MarinHealth Spine Institute, a UCSF Affiliate, 2 Bon Air Rd #120, Larkspur, CA, 94939, USA.
| | | | - Sean Li
- Premier Pain Centers (an affiliate of National Spine and Pain Centers), Shrewsbury, NJ, USA
| | - Caitlin Tourjé
- Spanish Hills Interventional Pain Specialists Inc, Camarillo, CA, USA
| | | | - David Dickerson
- Department of Anesthesiology, Critical Care and Pain Medicine, Endeavor Health, Evanston, IL, USA
- Pritzker School of Medicine, University of Chicago, Chicago, IL, USA
| | - Timothy R Lubenow
- Department of Anesthesiology, Rush University Medical Center, Chicago, IL, USA
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10
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Schultz DM, Bakke CH, Ruble HL, Larmour CS, Hagedorn JM, Abd-Elsayed A. Intrathecal Drug Delivery for Intractable Pain: Identified Patient Satisfaction Survey Study Comparing Intrathecal Dose With Satisfaction, Pain Relief, and Side Effects. Neuromodulation 2025:S1094-7159(24)01227-3. [PMID: 39755963 DOI: 10.1016/j.neurom.2024.11.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/30/2024] [Revised: 11/05/2024] [Accepted: 11/14/2024] [Indexed: 01/07/2025]
Abstract
OBJECTIVES Past studies have shown the efficacy of spinal targeted drug delivery (TDD) in pain relief, reduction in opioid use, and cost-effectiveness in long-term management of complex chronic pain. We conducted a survey to determine treatment variables associated with patient satisfaction. MATERIALS AND METHODS Patients in a single pain clinic who were implanted with Medtronic pain pumps to relieve intractable pain were identified from our electronic health record. From November 2021 to February 2023, 973 patients with active TDD were identified; 564 completed the 23-question survey, and 560 were included in analyses. Most patients (96.4%) had intrathecal (IT) infusion admixtures containing bupivacaine and opioid. The survey compared satisfaction with IT medication dosages, pain relief, pain diagnosis, catheter tip location, side effects, mental clarity, physical functioning, and healthcare utilization. Outcomes were reported as proportions; p < 0.05 was considered significant. RESULTS Most respondents reported good-to-excellent pain relief (63.8%), high satisfaction with TDD (80.7%), improvement in physical functioning (75.0%), and better quality of life (89.7%); 78.5% of respondents reported complete discontinuation or substantial reductions in systemic opioid use. There was a statistically significant relationship between satisfaction and IT medication dose (p = 0.02), with the average dose increasing with higher satisfaction groups. We found that patients on higher doses of IT opioids did not have more bothersome side effects (p = 0.05). CONCLUSIONS Our data show that the most satisfied respondents had higher IT doses, fewer side effects, and longer duration of TDD therapy. This suggests that higher dose IT admixtures are safe and effective at relieving pain and improving quality of life in patients with complex chronic pain whose condition has failed to respond adequately to other treatments. TDD may be an effective alternative to long-term systemic opioids for well-selected patients willing to accept the risks of invasive procedures.
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Affiliation(s)
- David M Schultz
- Nura Pain Clinic, Minneapolis MN, USA; Department of Anesthesia, Critical Care and Pain Medicine, University of Minnesota, Twin Cities, MN, USA.
| | | | | | | | - Jonathan M Hagedorn
- Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA
| | - Alaa Abd-Elsayed
- Department of Anesthesiology, University of Wisconsin, Madison, WI, USA
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11
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Dario A, Ferlendis L, Bossi B, Locatelli D. Preventing technique-related complications in spinal cord stimulation trials: The Dural Substitute Confetti technique. A retrospective monocentric analysis. Pain Pract 2025; 25:e13426. [PMID: 39435724 DOI: 10.1111/papr.13426] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/23/2024]
Abstract
BACKGROUND Spinal Cord Stimulation (SCS) is an established therapy for chronic pain, employing screening trials to identify suitable candidates before implantation. However, complications arising from both technique and medical factors present challenges to this practice. This study introduces the Dural Substitute Confetti technique, which addresses technique-related complications during SCS implantation by preventing scar-induced lead migration or breakage and reducing operating times. METHODS We conducted a retrospective analysis on 174 patients treated with SCS trials from 2017 to 2022 at our institution. Of these, 85.1% proceeded to permanent implantation. During trial surgery, synthetic dural substitutes (DS) were used to protect leads, which remained connected to an external pulse generator (EPG) for 20-28 days (mean 21.4 days). Utilizing the DS Confetti technique, leads were easily dissected from the DS during the second surgery and connected to an internal pulse generator (IPG). We compared complications and surgical times before and after the introduction of this technique in 2017. RESULTS Following the complete SCS trial, patients experienced over 50% pain relief, with an implant-to-trial ratio of 85.1% and a mean follow-up of 52 months. No technique-related complications occurred during the trial period post-2017, while the pre-2017 group had a 3.9% lead migration rate due to scarring, necessitating re-implantation. The average surgery duration decreased from 54 min pre-2017 to 32 min post-2017. Medical-related complications included infections (2.1%) and wound dehiscence (1.3%). CONCLUSIONS The DS Confetti technique prevents scar adhesion formation during screening trials, thereby facilitating and expediting the definitive SCS implantation. Additionally, it may also reduce the risk of lead migration and iatrogenic damage, potentially lowering technique-related complications.
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Affiliation(s)
- Alessandro Dario
- Division of Neurosurgery, Department of Biotechnology and Life Sciences, University of Insubria, Ospedale di Circolo e Fondazione Macchi, Varese, Italy
| | - Luca Ferlendis
- Division of Neurosurgery, Department of Biotechnology and Life Sciences, University of Insubria, Ospedale di Circolo e Fondazione Macchi, Varese, Italy
| | - Bianca Bossi
- Division of Neurosurgery, Department of Biotechnology and Life Sciences, University of Insubria, Ospedale di Circolo e Fondazione Macchi, Varese, Italy
| | - Davide Locatelli
- Division of Neurosurgery, Department of Biotechnology and Life Sciences, University of Insubria, Ospedale di Circolo e Fondazione Macchi, Varese, Italy
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Kim DC, Kang E, Lee HS, Park YH, Lee B, Kwon JY, Moon J, Lee SE. Challenges in removing an aged spinal cord stimulator: A case study of complete fracture in a 9-year-old S-series paddle lead. Pain Pract 2025; 25:e13429. [PMID: 39440391 DOI: 10.1111/papr.13429] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2024]
Abstract
INTRODUCTION This case report presents an instance of an S-Series™ slim paddle lead fracturing during extraction, highlighting potential risks associated with the removal of this lead. CASE REPORT A 47-year-old male with complex regional pain syndrome type 2, unresponsive to pharmacotherapy, had undergone the implantation of two spinal cord stimulator (SCS) leads, an Octrode™ cylindrical and an S-series™ slim paddle, using the Epiducer™ system (St Jude Medical) 9 years earlier, with a subsequent intrathecal baclofen pump installed 1 year after SCS. Initially, these interventions stabilized the patient's pain symptoms. However, the diminishing effectiveness of SCS, coupled with a decrease in battery life and increased opioid consumption, necessitated recent surgical procedures. These included the removal and replacement of the implantable pulse generator (IPG) and leads to improve pain management and ensure MRI compatibility. During the removal of the S-series™ slim paddle type lead, complications arose, leading to the retention of an electrode fragment, which necessitated abandoning the replacement of both the IPG and lead. Post-surgical assessments revealed no new neurological impairments, and imaging studies confirmed the stable position of the retained fragment. The patient was discharged with a continued comprehensive pain management plan. CONCLUSION This case highlights the challenges and risks of percutaneous removal of slim paddle type leads, emphasizing the need for careful procedural planning and consideration of surgical options to avoid complications. Further research is needed to evaluate the long-term durability and removal risks of various SCS lead types.
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Affiliation(s)
- Dong-Chun Kim
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Eunsu Kang
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Hyun-Seong Lee
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Yei Heum Park
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Byeongcheol Lee
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Ji Yeon Kwon
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Junseong Moon
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
| | - Sang Eun Lee
- Department of Anesthesiology and Pain Medicine, Haeundae Paik Hospital, Inje University, Busan, South Korea
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13
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da Silva Freitas T, Barbosa de Oliveira AJ, Golovac S, Assumpcao de Monaco B. Dorsal Root Ganglion Stimulation for Chronic Pelvic Pain Secondary to Endometriosis. Neuromodulation 2024:S1094-7159(24)01235-2. [PMID: 39729062 DOI: 10.1016/j.neurom.2024.11.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/06/2024] [Revised: 10/30/2024] [Accepted: 11/18/2024] [Indexed: 12/28/2024]
Abstract
INTRODUCTION Chronic pelvic pain (CPP) is a multifaceted condition that poses significant challenges in clinical management owing to its complex and varied pathophysiology, including neuropathic, somatic, visceral, and musculoskeletal components. Endometriosis is frequently associated with CPP, necessitating a comprehensive, multimodal treatment strategy. This approach typically includes physical and behavioral therapy, pharmacologic interventions, surgical management of endometriosis, and various pain-modulating procedures. Neuromodulation, particularly spinal cord stimulation (SCS), has been used in refractory cases; however, its use is often met with limited success and a notable rate of explants. This case series presents nine patients with intractable CPP secondary to endometriosis, unresponsive to conventional treatments, who were treated with dorsal root ganglion stimulation (DRG-S). MATERIALS AND METHODS Between 2022 and 2023, ten patients with severe CPP secondary to endometriosis, unresponsive to various multimodal treatments-including previous interventional pain procedures, gynecologic surgery, and in some cases, SCS-were recruited for this prospective study. Of these, nine patients underwent permanent DRG-S, with bilateral L1 and S2 DRG-S leads placed (four leads per patient). Patients were assessed for pain intensity using the visual analog scale (VAS), narcotic consumption, and quality of life (QoL) using the 12-item short-form (SF-12) survey, with a 12-month follow-up period. Nonparametric statistical analyses were conducted using SPSS. RESULTS One patient was excluded from the study owing to a lack of pain relief during the DRG-S trial. The remaining nine patients underwent permanent bilateral L1 and S2 DRG-S placement. Significant improvement in pain scores was observed and sustained throughout the follow-up period (VAS 9 ± 1.5-2 ± 2.0; p = 0.003), along with a marked reduction in opioid consumption, with four patients becoming completely free of narcotics (p = 0.046). SF-12 physical scores improved by 60.2 ± 7.8 (p = 0.006), and SF-12 mental scores improved by 45.9 ± 2.76 (p = 0.01). CONCLUSION Bilateral L1 and S2 DRG-S yielded robust and sustained outcomes, including significant improvements in pain scores, reduced narcotic consumption, and enhanced QoL over a 12-month follow-up period.
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Affiliation(s)
- Tiago da Silva Freitas
- Functional Neurosurgery - Syrian Lebanese Hospital, Brasilia, DF, Brazil; Functional Neurosurgery, Base Hospital, Brasilia, DF, Brazil
| | - Antonio Jorge Barbosa de Oliveira
- Functional Neurosurgery - Syrian Lebanese Hospital, Brasilia, DF, Brazil; Functional Neurosurgery, Base Hospital, Brasilia, DF, Brazil
| | | | - Bernardo Assumpcao de Monaco
- Functional and Pain Clinic, Sao Paulo, SP, Brazil; Pediatric Neurosurgery, Washington University in St. Louis, St Louis, MO, USA.
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14
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Zhong T, William HM, Jin MY, Abd-Elsayed A. A Review of Remote Monitoring in Neuromodulation for Chronic Pain Management. Curr Pain Headache Rep 2024; 28:1225-1233. [PMID: 39066995 DOI: 10.1007/s11916-024-01302-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 07/11/2024] [Indexed: 07/30/2024]
Abstract
PURPOSE OF REVIEW Neuromodulation techniques have emerged as promising strategies for managing chronic pain. These techniques encompass various modalities of nerve stimulation, including Spinal Cord Stimulation (SCS), Dorsal Root Ganglion Stimulation (DRG-S), and Peripheral Nerve Stimulation (PNS). Studies consistently demonstrate significant improvements in pain intensity, quality of life, and reduced opioid usage among patients treated with these modalities. However, neuromodulation presents challenges, such as the need for frequent in-person follow-up visits to ensure proper functionality of the implanted device. Our review explored factors impacting compliance in current neuromodulation users and examined how remote monitoring can mitigate some of these challenges. We also discuss outcomes of recent studies related to remote monitoring of neuromodulation. RECENT FINDINGS While remote monitoring capabilities for neuromodulation devices is an emerging development, there are promising results supporting its role in improving outcomes for chronic pain patients. Higher patient satisfaction, improved pain control, and reduced caretaker burdens have been observed with the use of remote monitoring. This review discusses the current challenges with neuromodulation therapy and highlights the role of remote monitoring. As the field continues to evolve, understanding the importance of remote monitoring for neuromodulation is crucial for optimizing pain management outcomes.
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Affiliation(s)
- Tammy Zhong
- Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Hannah M William
- Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Max Y Jin
- Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
| | - Alaa Abd-Elsayed
- Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
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15
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Gazzeri R, Galarza M, Occhigrossi F. Motor improvement and spasms recovery with high-frequency 10 kHz spinal cord stimulation in a patient with spastic tetraparesis: beyond pain relief. EUROPEAN SPINE JOURNAL : OFFICIAL PUBLICATION OF THE EUROPEAN SPINE SOCIETY, THE EUROPEAN SPINAL DEFORMITY SOCIETY, AND THE EUROPEAN SECTION OF THE CERVICAL SPINE RESEARCH SOCIETY 2024; 33:4750-4756. [PMID: 39322776 DOI: 10.1007/s00586-024-08505-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/29/2024] [Revised: 09/02/2024] [Accepted: 09/20/2024] [Indexed: 09/27/2024]
Abstract
PURPOSE To describe the clinical outcomes beyond pain relief of high-frequency spinal cord stimulation at 10 kHz (10 kHz SCS) in a patient with cervical myelopathy and drug-resistant chronic neuropathic pain with spastic tetraparesis. METHODS A patient with C3-C6 myelomalacia and spastic tetraparesis previously treated with decompressive laminectomy underwent implantation of 10 kHz SCS for pain management through a trial procedure followed by permanent implantation. Due to the presence of epidural fibrotic scar tissue in the area of the previous C3-C6 laminectomy, the leads could not be implanted at the cervical level; therefore, the leads were positioned at the thoracic level. Data were collected during routine follow-up visits up to 15 months after implantation. RESULTS Since the trialing phase and during all follow-up visits, along with complete pain relief in the lower limbs, a recovery from spasms was observed with an improvement in motor function. The patient recovered from a sensation of stiffness and difficulty in movement, with a significant decrease in muscle tone, regaining confidence in walking, and no longer needing assistance even for long walking distances. Although all disabling and painful symptomatology in the upper limbs instead did not ameliorate, the Oswestry Disability Index (ODI) score decreased from 50% at baseline to 6%. CONCLUSION To our knowledge, recovery from spasms and motor improvement in a spastic tetraparesis patient has never been reported before with 10 kHz SCS and possibly this new stimulation paradigm may overcome some performance limitations of traditional low-frequency SCS (LF-SCS). Treatment eliminated spasms at the lower limbs but not at the upper ones, thus suggesting that the location of the epidural leads could affect outcomes.
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Affiliation(s)
- Roberto Gazzeri
- Interventional and Surgical Pain Management Unit, San Giovanni Addolorata Hospital, Via Amba Aradam 9, Rome, 00136, Italy.
| | - Marcelo Galarza
- Regional Service of Neurosurgery, "Virgen de la Arrixaca" University Hospital, Murcia, Spain
| | - Felice Occhigrossi
- Interventional and Surgical Pain Management Unit, San Giovanni Addolorata Hospital, Via Amba Aradam 9, Rome, 00136, Italy
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16
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Garcia Cerqueira EM, de Medeiros RE, da Silva Fiorin F, de Arújo E Silva M, Hypolito Lima R, Azevedo Dantas AFO, Rodrigues AC, Delisle-Rodriguez D. Local field potential-based brain-machine interface to inhibit epileptic seizures by spinal cord electrical stimulation. Biomed Phys Eng Express 2024; 11:015016. [PMID: 39530641 DOI: 10.1088/2057-1976/ad9155] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2024] [Accepted: 11/12/2024] [Indexed: 11/16/2024]
Abstract
Objective.This study proposes a closed-loop brain-machine interface (BMI) based on spinal cord stimulation to inhibit epileptic seizures, applying a semi-supervised machine learning approach that learns from Local Field Potential (LFP) patterns acquired on the pre-ictal (preceding the seizure) condition.Approach.LFP epochs from the hippocampus and motor cortex are band-pass filtered from 1 to 13 Hz, to obtain the time-frequency representation using the continuous Wavelet transform, and successively calculate the phase lock values (PLV). As a novelty, theZ-score-based PLV normalization using both modifiedk-means and Davies-Bouldin's measure for clustering is proposed here. Consequently, a generic seizure's detector is calibrated for detecting seizures on the normalized PLV, and enables the spinal cord stimulation for periods of 30 s in a closed-loop, while the BMI system detects seizure events. To calibrate the proposed BMI, a dataset with LFP signals recorded on five Wistar rats during basal state and epileptic crisis was used. The epileptic crisis was induced by injecting pentylenetetrazol (PTZ). Afterwards, two experiments without/with our BMI were carried out, inducing epileptic crisis by PTZ in Wistar rats.Main results.Stronger seizure events of high LFP amplitudes and long time periods were observed in the rat, when the BMI system was not used. In contrast, short-time seizure events of relative low intensity were observed in the rat, using the proposed BMI. The proposed system detected on unseen data the synchronized seizure activity in the hippocampus and motor cortex, provided stimulation appropriately, and consequently decreased seizure symptoms.Significance.Low-frequency LFP signals from the hippocampus and motor cortex, and cord spinal stimulation can be used to develop accurate closed-loop BMIs for early epileptic seizures inhibition, as an alternative treatment.
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Affiliation(s)
- Erika Maria Garcia Cerqueira
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
| | - Raquel Emanuela de Medeiros
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
| | - Fernando da Silva Fiorin
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
| | - Mariane de Arújo E Silva
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
| | - Ramón Hypolito Lima
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
| | | | - Abner Cardoso Rodrigues
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
| | - Denis Delisle-Rodriguez
- Edmond and Lily Safra International Institute of Neurosciences, Santos Dumont Institute, 59288-899 Macaiba, Brazil
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Kim SH, Ramos CGL, Palan MJ, Kronquist E, Tan H, Elkholy MAE, Raslan A. Reoperation Rates and Risk Factors after Spinal Cord Stimulation Revision Surgery. Stereotact Funct Neurosurg 2024; 103:24-34. [PMID: 39471795 PMCID: PMC11794026 DOI: 10.1159/000541445] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/16/2024] [Accepted: 09/10/2024] [Indexed: 11/01/2024]
Abstract
INTRODUCTION Spinal cord stimulation (SCS) is an effective treatment for patients with refractory chronic pain. Despite its efficacy, rates of reoperation after initial implantation of SCS remain high. While revision rates after index SCS surgeries are well reported, less is known about rates and risk factors associated with repeat reoperations. We sought to evaluate patient, clinical, and surgical characteristics associated with repeat reoperation among patients who underwent an initial SCS revision procedure. METHODS We performed a retrospective review of patients who underwent SCS revision surgery performed at a single institution between 2008 and 2022. Patients were stratified by whether they underwent a single revision (SR) or multiple revision (MR) surgeries. Multivariate logistic regression was performed to determine risk factors associated with repeat SCS revision. Kaplan-Meier survival analysis was used to compare rates of devices requiring revision across groups. RESULTS A total of 54 patients underwent an initial SCS revision. Of these, 15 (28%) underwent a second revision. The most common indication for revision surgery was lead migration (65%). No significant differences were observed in age, body mass index, comorbidities, lead type, and revision indication among the SR and MR groups. On multivariate adjusted analysis, only cervical lead position was significantly associated with repeat reoperation (OR 7.10, 95% CI [1.14, 44.3], p = 0.036). Time to reoperation after a single and MR SCS surgeries did not differ. CONCLUSIONS Among patients who undergo SCS reoperation, a substantial portion requires additional revisions. Cervical lead placement may be associated with a higher risk of repeat revision surgery compared to thoracic lead positioning. Consideration of lead positioning in the decision to perform and undergo reoperation may therefore result in lower revision rates and improved clinical outcomes among SCS patients with MRs.
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Affiliation(s)
- Samuel H. Kim
- Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon
| | | | - Mihir J. Palan
- Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon
| | - Elise Kronquist
- Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon
| | - Hao Tan
- Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon
| | | | - Ahmed Raslan
- Department of Neurological Surgery, Oregon Health & Science University, Portland, Oregon
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Shirvalkar P. Neuromodulation for Neuropathic Pain Syndromes. Continuum (Minneap Minn) 2024; 30:1475-1500. [PMID: 39445930 DOI: 10.1212/con.0000000000001485] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2024]
Abstract
OBJECTIVE This article reviews the principles, applications, and emerging trends of neuromodulation as a therapeutic approach for managing painful neuropathic diseases. By parsing evidence for possible mechanisms of action and clinical trial outcomes for various diseases, this article focuses on five common therapy modalities: cutaneous, peripheral nerve, spinal cord, and brain stimulation, and intrathecal drug delivery. LATEST DEVELOPMENTS Recent advances in both invasive and noninvasive neuromodulation for pain have introduced personalized and closed-loop techniques, integrating real-time feedback mechanisms and combining therapies to improve physical and psychosocial function. Novel stimulation waveforms may influence distinct neural tissues to rectify pathologic pain signaling. ESSENTIAL POINTS With appropriate patient selection, peripheral nerve stimulation or epidural stimulation of the spinal cord can provide enduring relief for a variety of chronic pain syndromes. Newer technology using high frequencies, unique waveforms, or closed-loop stimulation may have selective advantages, but our current understanding of therapy mechanisms is very poor. For certain diagnoses and patients who meet clinical criteria, neuromodulation can provide profound, long-lasting relief that significantly improves quality of life. While many therapies are supported by data from large clinical trials, there is a risk of bias as most clinical studies were funded by device manufacturers or insurance companies, which increases the importance of real-world data analysis. Emerging methods like invasive or noninvasive brain stimulation may help us dissect basic mechanisms of pain processing and hold promise for personalized therapies for refractory pain syndromes. Finally, intrathecal delivery of drugs directly to segments of the spinal cord can also modify pain signaling to provide therapy for severe pain syndromes.
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Stegelmann SD, Rahmani R, Yim JM, Ahammad Z. Placement of spinal cord stimulation paddle leads in the thoracic spine using en bloc laminoplasty: A technical note. World Neurosurg X 2024; 24:100400. [PMID: 39399354 PMCID: PMC11470467 DOI: 10.1016/j.wnsx.2024.100400] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2023] [Accepted: 09/20/2024] [Indexed: 10/15/2024] Open
Abstract
Objective Spinal cord stimulation (SCS) has become a successful treatment option for managing chronic pain syndromes. Conventional methods for placing SCS leads include percutaneous insertion or open laminectomy in cases requiring better visualization. However, achieving accurate placement of paddle leads while minimizing surgical invasiveness remains a challenge in cases with anatomic constraints such as dural scarring. Methods We present a novel surgical technique for the placement of SCS paddle leads in the thoracic spine using en bloc laminoplasty, which is currently employed at our institution for patients with chronic pain syndromes. Conclusions This technique can provide accurate placement of paddle leads in patients with anatomic constraints or dural scarring that impede percutaneous implantation. Additionally, it offers potential structural advantages over laminectomy by reconstituting posterior stabilization and protection of the paddle leads.
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Affiliation(s)
| | - Roman Rahmani
- Department of Orthopaedic Surgery, Mercy Health St Vincent Medical Center, Toledo, OH, USA
| | - Jae Min Yim
- Department of Orthopaedic Surgery, Mercy Health St Vincent Medical Center, Toledo, OH, USA
| | - Zubair Ahammad
- Department of Neurosurgery, Mercy Health St Vincent Medical Center, Toledo, OH, USA
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20
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Gatzinsky K, Brink B, Eyglóardóttir KL, Hallén T. Long-term explantation risk in patients with chronic pain treated with spinal cord or dorsal root ganglion stimulation. Reg Anesth Pain Med 2024:rapm-2024-105719. [PMID: 39084704 DOI: 10.1136/rapm-2024-105719] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/30/2024] [Accepted: 07/15/2024] [Indexed: 08/02/2024]
Abstract
OBJECTIVE To investigate long-term explantation risks and causes for the explantation of neuromodulation devices for the treatment of chronic pain from different manufacturers. METHODS This retrospective analysis included patients implanted with a system for spinal cord stimulation (SCS) or dorsal root ganglion (DRG) stimulation at Sahlgrenska University Hospital between January 2012 and December 2022. Patient characteristics, explantation rates and causes for explantation were obtained by reviewing medical records. RESULTS In total, 400 patients were included in the study. Including all manufacturers, the cumulative explantation risk for any reason was 17%, 23% and 38% at 3, 5 and 10 years, respectively. Explantation risk due to diminished pain relief at the same intervals was 10%, 14% and 23%. A subgroup comparison of 5-year explantation risk using Kaplan-Meier analysis did not show a statistically significant difference between the manufacturers. In multivariable Cox regression analyses, there was no difference in explantation risk for any reason, but for explantation due to diminished pain relief, a higher risk was noted for Medtronic (preferably older types of SCS devices) and DRG stimulation. No other predictive factor for explantation was found. CONCLUSIONS Although SCS and DRG stimulation are well-established and safe treatments for chronic pain, the long-term explantation risk remains high. The difference between manufacturers highlights the importance of technological evolution for improving therapy outcomes. Increased stringency in patient selection and follow-up strategies, as well as further development of device hardware and software technology for increased longevity, could possibly reduce long-term explantation risks.
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Affiliation(s)
- Kliment Gatzinsky
- Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden
- Department of Clinical Neuroscience, University of Gothenburg Institute of Neuroscience and Physiology, Goteborg, Sweden
| | - Beatrice Brink
- Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Kristin Lilja Eyglóardóttir
- Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden
- Department of Clinical Neuroscience, University of Gothenburg Institute of Neuroscience and Physiology, Goteborg, Sweden
| | - Tobias Hallén
- Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden
- Department of Clinical Neuroscience, University of Gothenburg Institute of Neuroscience and Physiology, Goteborg, Sweden
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Paul C, Powell R, Lawson P. Thoracolumbar spinal cord stimulation: technique and overview. Tech Vasc Interv Radiol 2024; 27:100986. [PMID: 39490366 DOI: 10.1016/j.tvir.2024.100986] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2024]
Abstract
Since the introduction of spinal cord stimulation in 1967, the therapy has become a cornerstone in the treatment of several chronic pain syndromes, including but not limited to: postlaminectomy syndrome, lumbar radiculopathy, complex regional pain syndrome and diabetic peripheral neuropathy. This article aims to examine the methodology and practical considerations involved in thoracolumbar spinal cord stimulation implementation, emphasizing procedural techniques and critical criteria for selecting patients to achieve optimal outcomes and minimization of complications.
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Affiliation(s)
- Christopher Paul
- Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, AL.
| | - Rene Powell
- Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, AL
| | - Prentiss Lawson
- Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, AL
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22
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Malinowski MN, Gish BE, Moreira AM, Karcz M, Bracero LA, Deer TR. Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies. Expert Rev Med Devices 2024; 21:741-753. [PMID: 39044340 DOI: 10.1080/17434440.2024.2382234] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2024] [Accepted: 07/16/2024] [Indexed: 07/25/2024]
Abstract
INTRODUCTION For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society. AREAS COVERED We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data. EXPERT OPINION Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.
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Affiliation(s)
| | - Brandon E Gish
- Lexington Clinic Interventional Pain, Lexington, KY, USA
| | - Alexandra M Moreira
- Department of Anesthesiology, Rush University Medical Center, Chicago, IL, USA
| | - Marcin Karcz
- The Spine and Nerve Centers of the Virginias, Charleston, WV, USA
| | - Lucas A Bracero
- The Spine and Nerve Centers of the Virginias, Charleston, WV, USA
| | - Timothy R Deer
- The Spine and Nerve Centers of the Virginias, Charleston, WV, USA
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Deer TR, Russo M, Grider JS, Sayed D, Lamer TJ, Dickerson DM, Hagedorn JM, Petersen EA, Fishman MA, FitzGerald J, Baranidharan G, De Ridder D, Chakravarthy KV, Al-Kaisy A, Hunter CW, Buchser E, Chapman K, Gilligan C, Hayek SM, Thomson S, Strand N, Jameson J, Simopoulos TT, Yang A, De Coster O, Cremaschi F, Christo PJ, Varshney V, Bojanic S, Levy RM. The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for Spinal Cord Stimulation Long-Term Outcome Optimization and Salvage Therapy. Neuromodulation 2024; 27:951-976. [PMID: 38904643 DOI: 10.1016/j.neurom.2024.04.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2024] [Revised: 04/02/2024] [Accepted: 04/22/2024] [Indexed: 06/22/2024]
Abstract
INTRODUCTION The International Neuromodulation Society (INS) has recognized a need to establish best practices for optimizing implantable devices and salvage when ideal outcomes are not realized. This group has established the Neurostimulation Appropriateness Consensus Committee (NACC)® to offer guidance on matters needed for both our members and the broader community of those affected by neuromodulation devices. MATERIALS AND METHODS The executive committee of the INS nominated faculty for this NACC® publication on the basis of expertise, publications, and career work on the issue. In addition, the faculty was chosen in consideration of diversity and inclusion of different career paths and demographic categories. Once chosen, the faculty was asked to grade current evidence and along with expert opinion create consensus recommendations to address the lapses in information on this topic. RESULTS The NACC® group established informative and authoritative recommendations on the salvage and optimization of care for those with indwelling devices. The recommendations are based on evidence and expert opinion and will be expected to evolve as new data are generated for each topic. CONCLUSIONS NACC® guidance should be considered for any patient with less-than-optimal outcomes with a stimulation device implanted for treating chronic pain. Consideration should be given to these consensus points to salvage a potentially failed device before explant.
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Affiliation(s)
- Timothy R Deer
- The Spine and Nerve Center of the Virginias, Charleston, WV, USA.
| | - Marc Russo
- Hunter Pain Specialists, Newcastle, Australia
| | - Jay S Grider
- UKHealthCare Pain Services, Department of Anesthesiology, University of Kentucky College of Medicine, Lexington, KY, USA
| | - Dawood Sayed
- The University of Kansas Health System, Kansas City, KS, USA
| | | | | | - Jonathan M Hagedorn
- Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA
| | - Erika A Petersen
- University of Arkansas for Medical Sciences, Little Rock, AR, USA
| | | | | | - Ganesan Baranidharan
- Leeds Teaching Hospital National Health Service (NHS) Trust, University of Leeds, Leeds, UK
| | - Dirk De Ridder
- Dunedin School of Medicine, University of Otago, Dunedin, New Zealand
| | | | - Adnan Al-Kaisy
- Guy's and St Thomas NHS Foundation Trust, The Walton Centre for Neurology and Neurosurgery, Liverpool, UK
| | - Corey W Hunter
- Ainsworth Institute, Ichan School of Medicine, Mt Sinai Hospital, New York, NY, USA
| | | | | | - Chris Gilligan
- Brigham & Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Salim M Hayek
- Case Western Reserve University, University Hospitals of Cleveland, Cleveland, OH, USA
| | - Simon Thomson
- Pain & Neuromodulation Consulting Ltd, Nuffield Health Brentwood and The London Clinic, Brentwood, UK; Pain & Neuromodulation Centre, Mid & South Essex University NHS Hospitals, Basildon, UK
| | - Natalie Strand
- Department of Anesthesiology, Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA
| | | | - Thomas T Simopoulos
- Arnold Warfield Pain Management Center, Harvard Medical School, Boston, MA, USA
| | - Ajax Yang
- Spine and Pain Consultant, PLLC, Staten Island, NY, USA
| | | | - Fabián Cremaschi
- Department of Neurosciences, National University of Cuyo, Mendoza, Argentina
| | - Paul J Christo
- The Johns Hopkins University School of Medicine, Baltimore, MD, USA
| | - Vishal Varshney
- Providence Healthcare, University of British Columbia, Vancouver, British Columbia, Canada
| | - Stana Bojanic
- Oxford University Hospitals NHS Foundation Trust, Oxford, UK
| | - Robert M Levy
- Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA
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24
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Deer TR, Russo MA, Sayed D, Pope JE, Grider JS, Hagedorn JM, Falowski SM, Al-Kaisy A, Slavin KV, Li S, Poree LR, Eldabe S, Meier K, Lamer TJ, Pilitsis JG, De Andrés J, Perruchoud C, Carayannopoulos AG, Moeschler SM, Hadanny A, Lee E, Varshney VP, Desai MJ, Pahapill P, Osborn J, Bojanic S, Antony A, Piedimonte F, Hayek SM, Levy RM. The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation. Neuromodulation 2024; 27:977-1007. [PMID: 38878054 DOI: 10.1016/j.neurom.2024.04.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2024] [Revised: 03/27/2024] [Accepted: 04/08/2024] [Indexed: 08/09/2024]
Abstract
INTRODUCTION The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.
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Affiliation(s)
- Timothy R Deer
- The Spine and Nerve Center of the Virginias, Charleston, WV, USA.
| | | | - Dawood Sayed
- The University of Kansas Medical Center, Kansas City, KS, USA
| | | | - Jay S Grider
- UKHealthCare Pain Services, Department of Anesthesiology, University of Kentucky College of Medicine, Lexington, KY, USA
| | - Jonathan M Hagedorn
- Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN, USA
| | | | - Adnan Al-Kaisy
- Guy's and St. Thomas National Health Service (NHS) Foundation Trust, The Walton Centre for Neurology and Neurosurgery, Liverpool, UK
| | - Konstantin V Slavin
- Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL, USA; Neurology Section, Jesse Brown Veterans Administration Medical Center, Chicago, IL, USA
| | - Sean Li
- National Spine & Pain Centers, Shrewsbury, NJ, USA
| | - Lawrence R Poree
- Department of Anesthesia and Perioperative Care, University of California at San Francisco, San Francisco, CA, USA
| | - Sam Eldabe
- The James Cook University Hospital, Middlesbrough, UK
| | - Kaare Meier
- Department of Anesthesiology (OPINord), Aarhus University Hospital, Aarhus, Arhus, Denmark; Department of Neurosurgery (Afd. NK), Aarhus University Hospital, Aarhus, Arhus, Denmark
| | | | | | - Jose De Andrés
- Valencia School of Medicine, Anesthesia Critical Care and Pain Management Department, General University Hospital, Valencia, Spain
| | | | - Alexios G Carayannopoulos
- Department of Physical Medicine and Rehabilitation and Comprehensive Spine Center, Rhode Island Hospital, Providence, RI, USA; Brown University Warren Alpert Medical School (Neurosurgery), Providence, RI, USA
| | - Susan M Moeschler
- Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA
| | - Amir Hadanny
- Department of Neurosurgery, Albany Medical College, Albany, NY, USA
| | - Eric Lee
- Mililani Pain Center, Mililani, HI, USA
| | - Vishal P Varshney
- Anesthesiology and Pain Medicine, St. Paul's Hospital, Vancouver, British Columbia, Canada
| | - Mehul J Desai
- International Spine, Pain & Performance Center, Virginia Hospital Center, Monument Research Institute, George Washington University School of Medicine, Arlington, VA, USA
| | - Peter Pahapill
- Functional Neurosurgery, Medical College of Wisconsin, Milwaukee, WI, USA
| | - J Osborn
- St. Paul's Hospital, Vancouver, British Columbia, Canada
| | - Stana Bojanic
- Department of Neurosurgery, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
| | - Ajay Antony
- The Orthopaedic Institute, Gainesville, FL, USA
| | - Fabian Piedimonte
- School of Medicine, University of Buenos Aires, Buenos Aires, Argentina
| | - Salim M Hayek
- Case Western Reserve University, University Hospitals of Cleveland, Cleveland, OH, USA
| | - Robert M Levy
- Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA
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Goudman L, Moens M, Kelly S, Young C, Pilitsis JG. Incidence of Infections, Explantations, and Displacements/Mechanical Complications of Spinal Cord Stimulation During the Past Eight Years. Neuromodulation 2024; 27:1082-1089. [PMID: 37855766 DOI: 10.1016/j.neurom.2023.09.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2023] [Revised: 09/06/2023] [Accepted: 09/14/2023] [Indexed: 10/20/2023]
Abstract
OBJECTIVES The overall awareness and potential of real-world data have drastically increased in the medical field, with potential implications for postmarket medical device surveillance. The goal of this study was to evaluate real-world data on incidence of infections, explantations, and displacements/mechanical complications of spinal cord stimulation (SCS) during the past eight years and to forecast point estimates for the upcoming three years on the basis of the identified patterns. MATERIALS AND METHODS Based on electronic health records from 80 healthcare organizations within the TriNetX data base in the USA, data of 11,934 patients who received SCS as treatment for persistent spinal pain syndrome type 2 (PSPS T2) were extracted. Events of interest were explantations and displacements/mechanical complications of both the lead and implanted pulse generator (IPG), in addition to infection rates from 2015 to 2022. Mann-Kendall tests were performed to detect monotonic trends in the time series. Forecasts were conducted for the upcoming three years for every event of interest. RESULTS Statistically significant increasing time trends were revealed for the annual incidence of IPG and lead displacements/mechanical complications in patients with PSPS T2 over the past eight years. These time trends were visible in both male and female patients and in smokers and nonsmokers. For annual incidence of explantations and infections, no significant time effect was observed. In 2025, the incidence of displacements/mechanical complications of the lead (3.07%) is predicted to be the highest, followed by explantations of the IPG (2.67%) and lead (2.02%). CONCLUSIONS Based on real world data, device explantation was the most frequent event of interest, with negative peaks in the time series in 2016 and 2020, presumably due to the introduction of rechargeable pulse generators and to the COVID-19 pandemic, respectively.
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Affiliation(s)
- Lisa Goudman
- STIMULUS Research Group, Vrije Universiteit Brussel, Brussels, Belgium; Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Research Foundation-Flanders, Brussels, Belgium; Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA.
| | - Maarten Moens
- STIMULUS Research Group, Vrije Universiteit Brussel, Brussels, Belgium; Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Department of Radiology, Universitair Ziekenhuis Brussel, Brussels, Belgium
| | - Sophie Kelly
- Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA
| | - Christopher Young
- Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA
| | - Julie G Pilitsis
- Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA
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Nurmikko T, Mugan D, Leitner A, Huygen FJPM. Quantitative Sensory Testing in Spinal Cord Stimulation: A Narrative Review. Neuromodulation 2024; 27:1026-1034. [PMID: 38639705 DOI: 10.1016/j.neurom.2024.03.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2024] [Revised: 03/20/2024] [Accepted: 03/24/2024] [Indexed: 04/20/2024]
Abstract
OBJECTIVES Quantitative sensory testing (QST) has been used for decades to study sensory abnormalities in multiple conditions in which the somatosensory system is compromised, including pain. It is commonly used in pharmacologic studies on chronic pain but less so in conjunction with neuromodulation. This review aims to assess the utility of QST in spinal cord stimulation (SCS) protocols. MATERIALS AND METHODS For this narrative review, we searched PubMed for records of studies in which sensory testing has been performed as part of a clinical study on SCS from 1975 onward until October 2023. We focused on studies in which QST has been used to explore the effect of SCS on neuropathic, neuropathic-like, or mixed pain. RESULTS Our search identified 22 useful studies, all small and exploratory, using heterogeneous methods. Four studies used the full battery of validated German Research Network on Neuropathic Pain QST. There is emerging evidence that assessment dynamic mechanical allodynia (eight studies), and mechanical/thermal temporal summation of pain (eight studies) may have a role in quantifying the response to various SCS waveforms. There also were sporadic reports of improvement of sensory deficits in a proportion of patients with neuropathic pain that warrant further study. CONCLUSIONS We recommend the adoption of QST into future clinical research protocols, using either the full QST protocol or a less time-demanding short-form QST.
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Affiliation(s)
- Turo Nurmikko
- Department of Pain Medicine, The Walton Centre NHS Trust, Liverpool, UK.
| | - Dave Mugan
- Saluda Medical Europe Ltd, Harrogate, UK
| | - Angela Leitner
- Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia
| | - Frank J P M Huygen
- Center for Pain Medicine, Erasmus University Medical Center, Rotterdam and UMCU, Utrecht, The Netherlands
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Khabbass M, Saleki M, Bretherton B, Baranidharan G. Improvement in Health-Related Quality of Life With Spinal Cord Stimulation in Complex Regional Pain Syndrome: A Single-Center, Retrospective Study. Neuromodulation 2024; 27:1035-1044. [PMID: 38829296 DOI: 10.1016/j.neurom.2024.04.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/31/2023] [Revised: 04/05/2024] [Accepted: 04/09/2024] [Indexed: 06/05/2024]
Abstract
BACKGROUND Complex regional pain syndrome (CRPS) can profoundly affect many aspects of everyday life. Spinal cord stimulation (SCS) is a potential therapeutic option. This retrospective, single-site evaluation explored health-related quality of life (HRQoL) in individuals with CRPS treated with SCS in our Pain Service. MATERIALS AND METHODS All patients aged ≥18 years with fully implanted SCS for CRPS between June 2013 and January 2023 were identified from hospital records. The following data were collected: sex, age, chronic pain diagnosis, CRPS type (I or II), location of CRPS (upper or lower limb), years of CRPS before first SCS implant, SCS system, preimplant and follow-up scores for HRQoL (euroqol 5 dimensions 3 levels [EQ-5D-3L] index score), average pain, worst pain and the influence of pain on aspects of everyday life (all numerical rating scale [NRS]), patient and clinician global impression of change at follow-up, and the occurrence and reasons for revisions and explants. An intention-to-treat approach was used and data statistically analyzed. RESULTS The final cohort comprised 83 patients (46 women), with a median (minimum, maximum) follow-up duration of 29 months (seven, 72). There were statistically and clinically significant improvements in HRQoL, despite relatively low pain response rates. The pain response rate was 34% (reduction of ≥30% in average pain NRS); the pain remission rate was 13% (average pain score ≤3 NRS), and all patients had preimplant EQ-5D-3L index values below the population norm of 0.82. However, 60% of patients reported EQ-5D-3L index scores greater than the published minimally important difference of 0.074, and scores were better at follow-up than at preimplant (p < 0.001); 44% of patients and 41% of clinicians reported improved symptoms at the most recent follow-up. Explants occurred in eight of 83 patients (10%). CONCLUSIONS Patients had meaningful improvements in HRQoL, which is a key outcome in ascertaining the overall outcome of SCS in CRPS. Randomized controlled clinical trials should build on the findings to improve understanding of the benefits and risks of treating CRPS with SCS.
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Affiliation(s)
- Mazen Khabbass
- Pain Management Department, Leeds Teaching Hospitals National Health Service Trust, Leeds, UK
| | - Mohammad Saleki
- Pain Management Department, Leeds Teaching Hospitals National Health Service Trust, Leeds, UK
| | - Beatrice Bretherton
- Pain Management Department, Leeds Teaching Hospitals National Health Service Trust, Leeds, UK; School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, UK
| | - Ganesan Baranidharan
- Pain Management Department, Leeds Teaching Hospitals National Health Service Trust, Leeds, UK; School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.
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Kurt E, Kollenburg L, Joosten S, van Dongen R, Engels Y, Henssen D, Vissers K. Preoperative Counseling in Spinal Cord Stimulation: A Designated Driver in Implantable Pulse Generator-Related Inconveniences? Neuromodulation 2024:S1094-7159(24)00630-5. [PMID: 39001726 DOI: 10.1016/j.neurom.2024.05.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2024] [Revised: 05/26/2024] [Accepted: 05/31/2024] [Indexed: 07/15/2024]
Abstract
BACKGROUND Spinal cord stimulation (SCS) has been reported to cause substantial pain relief and improved quality of life (QoL) in patients with persistent spinal pain syndrome (PSPS). Despite implantable pulse generator (IPG)-related inconveniences such as pain, shame, and discomfort affecting QoL and patient satisfaction, these are often neglected. Hence, the current study aims to determine the associations between patient satisfaction, IPG-related inconveniences, and preoperative counseling in a homogeneous group of patients with PSPS receiving SCS with IPG implantation in the gluteal or abdominal area. MATERIALS AND METHODS Retrospective data on sample characteristics were gathered from the EPIC (electronic health record software) digital patient data base. Prospective data on patient satisfaction were obtained with a questionnaire that covered various topics such as shame, pain, disturbances in daily/intense activities, night rest and/or sleep, discomfort caused by clothing, and preoperative counseling. The exact location of the IPG and its scar were determined with photo analysis. Thereafter, the site of IPG placement was classified into separate quadrants within the gluteal and abdominal area. Patient satisfaction was defined as accepting the current location of the IPG without having the wish to undergo revision surgery. RESULTS In total, 81 participants (50.9 ± 10 years) were included in this analysis, with patient satisfaction observed in 61 patients (75.3%). Among satisfied patients, more extensive preoperative counseling concerning IPG pain and discomfort was reported compared with patients who were not satisfied (p < 0.001). When comparing the two groups, significant differences were found in shame (8/81, 9.9%), IPG site pain (21/81, 25.9%), disturbance of activities (42/81, 51.9%), and clothing-related discomfort (42/81, 51.9%). CONCLUSIONS On the basis of the current results, shared decision-making and comprehensive preoperative provision of information are recommended to optimize patient satisfaction regarding IPG pain, discomfort, and inconveniences. Although many patients experience these disadvantages despite successful SCS for pain related to PSPS, most of them accept this if they have received adequate preoperative information about expectations.
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Affiliation(s)
- Erkan Kurt
- Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
| | - Linda Kollenburg
- Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Sisley Joosten
- Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Robert van Dongen
- Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Yvonne Engels
- Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Dylan Henssen
- Department of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Kris Vissers
- Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
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Buonanno P, Servillo G, Visser-Vandewalle V, Matis G. 10 kHz stimulation as rescue therapy for spinal cord stimulation trial failure or loss of efficacy: A retrospective study. Pain Pract 2024; 24:845-851. [PMID: 38558532 DOI: 10.1111/papr.13369] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Revised: 02/25/2024] [Accepted: 03/19/2024] [Indexed: 04/04/2024]
Abstract
INTRODUCTION Spinal cord stimulation (SCS) is currently used for the management of pain of different origin, and since its inception, many waveforms have been developed. Some patients experience no pain relief already during SCS trial, while other patients go through a loss of efficacy due to habituation after a variable period of satisfying pain control. Our retrospective study represents the first report exploring the potential role of 10 kHz stimulation as rescue therapy for patients who did not benefit not only from conventional stimulation but even from other waveforms during SCS trial or follow-up. METHODS This study was conducted in Germany; we retrospectively enrolled patients with no pain relief during SCS trial or with loss of efficacy of other waveforms over time; and we recorded visual analogic scale (VAS), Oswestry Disability Index (ODI), and daily opioid consumption expressed as morphine milligram equivalents (MME), right before and 12 months after the switching to 10 kHz simulation. RESULTS The rate of successful switching to 10 kHz stimulation was comparable in patients enrolled during the SCS trial and during the follow-up (43% vs. 40%, respectively); notably, the highest rate of failed rescue was recorded in case of persistent spinal pain syndrome (PSPS) II. Patients who responded to the switching showed a significant improvement in VAS and ODI after 12 months of treatment compared to baseline (3.6 ± 1.0 vs. 8.2 ± 0.9, p < 0.00001 and 34.0 ± 7.8 vs. 64.3 ± 8.7, p < 0.0001, respectively), whereas there was no reduction in the consumption of opioids in terms of MME (3 (0-16) vs. 5 (0-8.75), p = 0.1003). CONCLUSIONS Rescue therapy with 10 kHz stimulation could be an important strategy to avoid SCS explant in both patients non-responsive during trial or experiencing a loss of efficacy during the years with other waveforms.
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Affiliation(s)
- Pasquale Buonanno
- Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples "Federico II", Naples, Italy
| | - Giuseppe Servillo
- Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples "Federico II", Naples, Italy
| | - Veerle Visser-Vandewalle
- Department of Stereotactic and Functional Neurosurgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany
| | - Georgios Matis
- Department of Stereotactic and Functional Neurosurgery, Faculty of Medicine and University Hospital of Cologne, University of Cologne, Cologne, Germany
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30
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Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Sayed D, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Maislin G, Heemels JP, Eldabe S. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation 2024; 27:930-943. [PMID: 38483366 DOI: 10.1016/j.neurom.2024.01.006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/02/2023] [Revised: 01/11/2024] [Accepted: 01/26/2024] [Indexed: 07/08/2024]
Abstract
BACKGROUND Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology. MATERIALS AND METHODS In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data. RESULTS At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed. CONCLUSION Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction. CLINICAL TRIAL REGISTRATION The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).
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Affiliation(s)
- Christopher Gilligan
- Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA.
| | | | - Marc Russo
- Hunter Pain Specialists, Newcastle, Australia
| | | | - Christopher Gilmore
- Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA
| | - Vivek Mehta
- Barts Neuromodulation Centre, St. Bartholomew's Hospital, London, United Kingdom
| | - Kristiaan Deckers
- Department of Physical Medicine and Rehabilitation, GZA - Sint Augustinus Hospital, Wilrijk, Belgium
| | - Kris De Smedt
- Department of Neurosurgery, GZA - Sint Augustinus Hospital, Wilrijk, Belgium
| | - Usman Latif
- Department of Anesthesiology, University of Kansas School of Medicine, Kansas City, KS, USA
| | - Dawood Sayed
- Department of Anesthesiology, University of Kansas School of Medicine, Kansas City, KS, USA
| | - Peter Georgius
- Sunshine Coast Clinical Research, Noosa Heads, Australia
| | | | | | | | - Frank Huygen
- Department of Anaesthesiology Erasmus Medical Center, Rotterdam, the Netherlands
| | - Ganesan Baranidharan
- Leeds Pain and Neuromodulation Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK
| | - Vikas Patel
- Department of Orthopedic Surgery, University of Colorado, Denver, CO, USA
| | - Eugene Mironer
- Carolinas Center for the Advanced Management of Pain, Spartanburg, NC, USA
| | - Edgar Ross
- Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA
| | - Alexios Carayannopoulos
- Departments of Physical Medicine and Rehabilitation, Rhode Island Hospital, Brown University Medical School, Providence, RI, USA
| | - Salim Hayek
- Division of Pain Medicine, University Hospitals, Cleveland Medical Center, Cleveland, OH, USA
| | - Ashish Gulve
- Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK
| | | | | | - Jeffrey Fischgrund
- Department of Orthopedic Surgery, Oakland University, Beaumont Hospital, Royal Oak, MI, USA
| | - Shivanand Lad
- Department of Neurosurgery, Duke University Medical Center, Durham, NC, USA
| | - Farshad Ahadian
- Center for Pain Medicine, University of California, San Diego, CA, USA
| | - Timothy Deer
- The Spine and Nerve Center of the Virginias, Charleston, WV, USA
| | - William Klemme
- Uniformed Services University of the Health Sciences, Bethesda, MD, USA
| | - Richard Rauck
- Carolinas Pain Institute, Wake Forest University, Winston-Salem, NC, USA
| | - James Rathmell
- Division of Pain Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA, USA
| | - Greg Maislin
- Biomedical Statistical Consulting, Wynnewood, PA, USA
| | | | - Sam Eldabe
- Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK
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Patil AS, Levasseur B, Gupta M. Neuromodulation and Habituation: A Literature Review and Conceptional Analysis of Sustaining Therapeutic Efficacy and Mitigating Habituation. Biomedicines 2024; 12:930. [PMID: 38790891 PMCID: PMC11118194 DOI: 10.3390/biomedicines12050930] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2024] [Revised: 04/14/2024] [Accepted: 04/18/2024] [Indexed: 05/26/2024] Open
Abstract
Spinal cord stimulation (SCS) is a therapeutic modality for the treatment of various chronic pain conditions that has rapidly evolved over the past 50 years. Unfortunately, over time, patients implanted with SCS undergo a habituation phenomenon leading to decreased pain relief. Consequently, the discovery of new stimulation waveforms and SCS applications has been shown to prolong efficacy and reduce explantation rates. This article explores various SCS waveforms, their applications, and proposes a graded approach to habituation mitigation. We suspect the neural habituation phenomenon parallels that seen in pharmacology. Consequently, we urge further exploration of the early introduction of these stimulation strategies to abate spinal cord stimulation habituation.
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Affiliation(s)
- Anand S. Patil
- St. Luke’s Rehabilitation Medical Center, Spokane, WA 99202, USA
| | | | - Mayank Gupta
- Neuroscience Research Center, LLC, Overland Park, KS 66215, USA
- Kansas Pain Management, Overland Park, KS 66210, USA
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Krog L, Maloney J, Pew S, Adeleye O, Johnson B, Glenn B, Gill B, Tieppo Francio V, Pagan-Rosado R, Whitney M, Sinha N, Strand N. Cervical Spinal Cord Stimulation: A Review. Curr Pain Headache Rep 2024; 28:239-249. [PMID: 38147282 DOI: 10.1007/s11916-023-01200-8] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/04/2023] [Indexed: 12/27/2023]
Abstract
PURPOSE OF REVIEW This literature review critically examines existing studies on cervical spinal cord stimulation (cSCS) for the treatment of chronic pain. The objective is to evaluate the current evidence, identify knowledge gaps, and collate data to inform clinical decision-making and suggest future research avenues. The review covers indications, contraindications, surgical and anesthetic approaches, trials, efficacy, and complications of cSCS. RECENT FINDINGS Recent advancements highlight the evolving role of cSCS in chronic pain management. New neuromodulation techniques involve optimal placement of leads based on the pain's innervation level, maximizing therapeutic outcomes. Contemporary studies underscore the broadening benefits of cSCS, including enhanced functional abilities and sleep quality. However, alongside these innovations come challenges; emerging data bring attention to complications such as hardware issues and infections. Significantly, modern research emphasizes the crucial role of accurate patient selection, factoring in prior therapy responses and comprehensive evaluations. cSCS emerges as a promising tool for chronic pain management, with benefits beyond mere pain relief. As surgical techniques, patient selection criteria, and postoperative care refine, the potential of cSCS expands to benefit a broader patient demographic. However, further comprehensive research is necessary to enhance its application, validate its role earlier in treatment, and ultimately ameliorate the lives of those with chronic pain.
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Affiliation(s)
- Lucky Krog
- Mayo Clinic Alix School of Medicine, Scottsdale, AZ, USA.
| | | | - Scott Pew
- Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA
| | | | - Brooks Johnson
- Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Phoenix, AZ, USA
| | - Brett Glenn
- College of Medicine, University of Arkansas for Medical Sciences, Fayetteville, AR, USA
| | - Benjamin Gill
- Department of Anesthesiology and Pain Medicine, University of Utah, Salt Lake City, UT, USA
| | - Vinicius Tieppo Francio
- University of Kansas Medical Center, Department of Anesthesiology and Pain Medicine, Kansas City, KS, USA
| | | | | | - Neil Sinha
- Mayo Clinic Alix School of Medicine, Scottsdale, AZ, USA
| | - Natalie Strand
- Division of Pain Medicine, Mayo Clinic, Phoenix, AZ, USA
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Burke L, Desai MJ. Pocket pain following spinal cord stimulator generator implantation: A narrative review of this under-reported risk. Pain Pract 2024; 24:659-669. [PMID: 38102862 DOI: 10.1111/papr.13336] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2023]
Abstract
INTRODUCTION Spinal cord stimulation (SCS) is a well-established treatment option for chronic pain. Pain over the implantable pulse generator, or pocket pain, is an incompletely understood risk of SCS implantation which may limit the efficacy of treatment and patient quality of life. The goal of this narrative review is to analyze the literature to gain a more thorough understanding of the incidence and risk factors for the development of pocket pain to help guide treatment options and minimize its occurrence in the future. METHODS A literature review was conducted investigating the development of pocket pain in patients with SCS for the management of a variety of pain conditions. RESULTS In total, 305 articles were included in the original database search and 50 met the criteria for inclusion. The highest level of evidence for papers that specifically investigated pocket pain was level III. Four retrospective, observational analyses included pocket pain as a primary outcome. The remainder of the included studies listed pocket pain as an adverse event of SCS implantation. CONCLUSIONS There is a relative dearth of primary literature that examines the incidence, characteristics, and health economic implications of pocket pain in patients with SCS. This highlights the need for large-scale, high-quality prospective or randomized controlled trials examining pocket pain. This may ultimately help prevent and reduce pocket pain leading to improved efficacy of treatment and greater patient quality of life.
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Affiliation(s)
- Lindsay Burke
- Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, Colorado, USA
| | - Mehul J Desai
- International Spine, Pain & Performance Center, Washington, DC, USA
- School of Medicine and Health Sciences, George Washington University, Washington, DC, USA
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Burns SL, Majdak P, Adler AR, Jo C, Chiang MC, Yong RJ, Barreveld AM. Dorsal root ganglion stimulation for patients with chronic pelvic pain: A retrospective review of patient experiences and long-term outcomes. INTERVENTIONAL PAIN MEDICINE 2024; 3:100397. [PMID: 39239506 PMCID: PMC11372976 DOI: 10.1016/j.inpm.2024.100397] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/08/2023] [Revised: 02/17/2024] [Accepted: 02/17/2024] [Indexed: 09/07/2024]
Abstract
Introduction Chronic pelvic pain (CPP) is a refractory condition that has physical, emotional, and financial impacts on patients. Dorsal root ganglion stimulation (DRGS) is a promising interventional modality for patients with refractory CPP, however studies of long-term outcomes are limited. We aim to present the results from a retrospective review of 31 patients with CPP treated using DRGS. Materials and methods IRB approval was obtained. A retrospective chart review was conducted, including 31 patients who underwent a DRGS trial between 2017 and 2022 at two academic centers. Pain history, trial/implant lead configuration, complications/revisions, pain scores, functional goals, and medication use were recorded. Results Thirty-one patients with CPP underwent a 7-10 day DRGS trial between 2017 and 2022. Of the 31 patients, 21 (68%, CI 50-81%) had a successful trial, defined as >50% reported pain relief. Twenty patients underwent DRGS implantation. Average follow-up was 28.2 ± 17.3 months. Nine patients (45%) required revision surgery for lead migration or fracture. Thirteen patients remain implanted with an average reported percent relief of 55 ± 15%. Seven patients were explanted (35%), with an average time to explant of 12.5 ± 3 months. Conclusions This study presents one of the largest groups of patients with DRGS for the treatment of CPP. The results highlight the variable experiences of patients after DRGS trial/implant. We report on the incidence of lead migration and fracture, sparingly described in the literature. Larger, prospective studies are needed to elucidate which patients with CPP may benefit most from DRGS, and to better understand the incidence and implications of complications.
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Affiliation(s)
- Stacey L Burns
- Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA
| | - Petra Majdak
- Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA
| | - Alexandra R Adler
- Lowell General Hospital, 2 Hospital Dr 2nd Floor, Lowell, MA, 01852, USA
| | - Celine Jo
- Tufts University School of Medicine, 145 Harrison Ave, Boston, MA, 02111, USA
| | - Michael C Chiang
- Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA
| | - Robert Jason Yong
- Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA, 02115, USA
| | - Antje M Barreveld
- Newton Wellesley Hospital, 159 Well Ave, Pain Service, Newton, MA, 02459, USA
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Bieze M, van Haaps AP, Kapural L, Li S, Ferguson K, de Vries R, Schatman ME, Mijatovic V, Kallewaard JW. Spinal Cord Stimulation for Intractable Visceral Pain Originating from the Pelvic and Abdominal Region: A Narrative Review on a Possible New Indication for Patients with Therapy-Resistant Pain. J Pain Res 2024; 17:691-736. [PMID: 38405684 PMCID: PMC10887953 DOI: 10.2147/jpr.s445616] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/20/2023] [Accepted: 02/03/2024] [Indexed: 02/27/2024] Open
Abstract
Aim Visceral pain, characterized by pain that is diffuse and challenging to localize, occurs frequently and is difficult to treat. In cases where the pain becomes intractable despite optimal medical management, it can affect patients' Quality of Life (QoL). Spinal Cord Stimulation (SCS) has emerged as a potential solution for intractable visceral pain. Purpose In this narrative review, we collected all evidence regarding the efficacy of SCS for visceral pain across various underlying conditions. Methods A comprehensive literature search was conducted in PubMed, Embase, and Web of Science in which articles published from October 1st, 1963 up to March 7th, 2023 were identified. Results Seventy articles were included in this review of which most were retrospective cohort studies, case series and case reports. The studies, often with a small number of participants, reported on SCS for chronic pancreatitis, anorectal pain and bowel disorders, gynaecological diagnoses, visceral pelvic pain, urological disorders and finally general visceral pain. They found positive effects on pain and/or symptom relief, opioid consumption, anxiety and depression and QoL. Complications occurred frequently but were often minor and reversible. Conclusion Better screening and selection criteria need to be established to optimally evaluate eligible patients who might benefit from SCS. A positive outcome of a sympathetic nerve block appears to be a potential indicator of SCS effectiveness. Additionally, women receiving SCS for endometriosis had a better outcome compared to other indications. Finally, SCS could also relief functional symptoms such as voiding problems and gastroparesis. Complications could often be resolved with revision surgery. Since SCS is expensive and not always covered by standard health insurance, the incorporation of cost-analyses is recommended. In order to establish a comprehensive treatment plan, including selection criteria for SCS, rigorous prospective, possibly randomized and controlled studies that are diagnosis-oriented, with substantial follow-up and adequate sample sizes, are needed.
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Affiliation(s)
- Matthanja Bieze
- Department of Anesthesiology and Pain Management, Amsterdam UMC Location University of Amsterdam, Amsterdam, the Netherlands
- Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada
| | - Annelotte Pauline van Haaps
- Department of Reproductive Medicine, Amsterdam University Medical Center location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
- Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | - Leonardo Kapural
- Carolina’s Pain Institute and Center for Clinical Research, Winston Salem, North Carolina, USA
| | - Sean Li
- National Spine and Pain Centers, Shrewsbury, New Jersey, USA
| | - Kris Ferguson
- Aspirus Langlade Hospital Pain Clinic, Antigo, Wisconsin, USA
| | - Ralph de Vries
- Medical Library, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
| | - Michael E Schatman
- Department of Anesthesiology, Perioperative Care & Pain Medicine, NYU Grossman School of Medicine, New York, New York, USA
- Department of Population Health – Division of Medical Ethics, NYU Grossman School of Medicine, New York, New York, USA
| | - Velja Mijatovic
- Department of Reproductive Medicine, Amsterdam University Medical Center location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
- Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, the Netherlands
| | - Jan Willem Kallewaard
- Department of Anesthesiology and Pain Management, Amsterdam UMC Location University of Amsterdam, Amsterdam, the Netherlands
- Department of Anesthesiology and Pain Management, Rijnstate Ziekenhuis, Arnhem, the Netherlands
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Rigoard P, Billot M, Bougeard R, Llopis JE, Raoul S, Matis G, Vesper J, Belaïd H. Improved Outcomes and Therapy Longevity after Salvage Using a Novel Spinal Cord Stimulation System for Chronic Pain: Multicenter, Observational, European Case Series. J Clin Med 2024; 13:1079. [PMID: 38398392 PMCID: PMC10889739 DOI: 10.3390/jcm13041079] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2023] [Revised: 02/02/2024] [Accepted: 02/06/2024] [Indexed: 02/25/2024] Open
Abstract
Spinal cord stimulation (SCS) is proven to effectively relieve chronic neuropathic pain. However, some implanted patients may face loss of efficacy (LoE) over time, and conversion to more recent devices may rescue SCS therapy. Recent SCS systems offer novel stimulation capabilities, such as temporal modulation and spatial neural targeting, and can be used to replace previous neurostimulators without changing existing leads. Our multicenter, observational, consecutive case series investigated real-world clinical outcomes in previously implanted SCS patients who were converted to a new implantable pulse generator. Data from 58 patients in seven European centers were analyzed (total follow-up 7.0 years, including 1.4 years after conversion). In the Rescue (LoE) subgroup (n = 51), the responder rate was 58.5% at the last follow-up, and overall pain scores (numerical rating scale) had decreased from 7.3 ± 1.7 with the previous SCS system to 3.5 ± 2.5 (p < 0.0001). Patients who converted for improved battery longevity (n = 7) had their pain scores sustained below 3/10 with their new neurostimulator. Waveform preferences were diverse and patient dependent (34.4% standard rate; 44.8% sub-perception modalities; 20.7% combination therapy). Our results suggest that patients who experience LoE over time may benefit from upgrading to a more versatile SCS system.
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Affiliation(s)
- Philippe Rigoard
- PRISMATICS Lab, Poitiers University Hospital, 86021 Poitiers, France;
| | - Maxime Billot
- PRISMATICS Lab, Poitiers University Hospital, 86021 Poitiers, France;
| | | | | | - Sylvie Raoul
- CHU de Nantes-Hopital Laennec, 44800 Saint-Herblain, France;
| | | | - Jan Vesper
- Universitaetsklinikum Dusseldorf, 40225 Dusseldorf, Germany;
| | - Hayat Belaïd
- Fondation Adolphe de Rothschild, 75019 Paris, France;
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Zhu C, Esteller R, Block J, Lechleiter K, Frey R, Moffitt MA. Exploratory evaluation of spinal cord stimulation with dynamic pulse patterns: a promising approach to improve stimulation sensation, coverage of pain areas, and expected pain relief. FRONTIERS IN PAIN RESEARCH 2024; 4:1339892. [PMID: 38361978 PMCID: PMC10867969 DOI: 10.3389/fpain.2023.1339892] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/17/2023] [Accepted: 12/28/2023] [Indexed: 02/17/2024] Open
Abstract
Background The societal burden of chronic pain and the contribution-in-part to the opioid crisis, is a strong motivation to improve and expand non-addictive treatments, including spinal cord stimulation (SCS). For several decades standard SCS has consisted in delivery of tonic pulses with static parameter settings in frequency, pulse width, and amplitude. These static parameters have limited ability to personalize the quality of paresthesia, the dermatomal coverage, and thus may affect SCS efficacy. Further, static settings may contribute to the build-up of tolerance or loss of efficacy of the therapy over time in some patients. Methods We conducted an acute exploratory study to evaluate the effects of SCS using time-dynamic pulses as compared to time-static (conventional tonic) stimulation pulses, with the hypotheses that dynamic pulse SCS may enable beneficial tailoring of the sensation and the patient's expectation for better pain relief with SCS. During a single clinic visit, consented subjects undergoing a standard SCS trial had their implanted leads temporarily connected to an investigational external stimulator capable of delivering time-static and six categories of time-dynamic pulse sequences, each characterized by continuously varying a stimulation parameter. Study subjects provided several assessments while blinded to the stimulation pattern, including: drawing of paresthesia maps, descriptions of sensation, and ratings for comfort and helpfulness to pain relief. Results Even without optimization of the field location, a majority of subjects rated sensations from dynamic stimulation as better or equal to that of static stimulation for comfortableness and for helpfulness to pain relief. The initial data showed a gender and/or pain dermatomal location related preference to a stimulation pattern. In particular, female subjects and subjects with pain at higher dermatomes tended to rank the sensation from dynamic stimulation better. Dynamic stimulation produced greater pain coverage without optimization; in 70% (9/13) of subjects, maximal pain coverage was achieved with a dynamic stimulation pattern. There was also greater variety in the words used by patients to describe stimulation sensation in the free text and free form verbal descriptions associated with dynamic stimulation. Conclusions With the same electrode configuration and comparable parameter settings, acute SCS using dynamic pulses produced more positive ratings, expanded paresthesia coverage, and greater variation in sensation as compared to SCS using static pulses, suggesting that dynamic stimulation has the potential to improve capabilities of SCS for the treatment of chronic pain. Further study is warranted. Trial Registration This study was registered at ClinicalTrials.gov under ID NCT02988713, November 2016 (URL: https://clinicaltrials.gov/ct2/show/NCT02988713).
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Affiliation(s)
- Changfang Zhu
- Research and Development, Boston Scientific Neuromodulation, Valencia, CA, United States
| | - Rosana Esteller
- Research and Development, Boston Scientific Neuromodulation, Valencia, CA, United States
| | - Jessica Block
- Research and Development, Boston Scientific Neuromodulation, Valencia, CA, United States
| | - Kristen Lechleiter
- Clinical Research, Boston Scientific Neuromodulation, Valencia, CA, United States
| | - Robert Frey
- Pacific Pain Management Inc., Ventura, CA, United States
| | - Michael A. Moffitt
- Research and Development, Boston Scientific Neuromodulation, Valencia, CA, United States
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Salmasi V, Rasouli MR, Kao MC, Ottestad E, Terkawi AS, Morris G, Qian X, Coleman S, Talavera DC, Poupore-King H, Slater K, Leong MS. Application of multidisciplinary team conference for neuromodulation candidates facilitates patient selection and optimization. FRONTIERS IN PAIN RESEARCH 2024; 4:1331883. [PMID: 38249566 PMCID: PMC10796794 DOI: 10.3389/fpain.2023.1331883] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/01/2023] [Accepted: 12/18/2023] [Indexed: 01/23/2024] Open
Abstract
Introduction Psychological evaluation is required by insurance companies in the United States prior to proceeding with a spinal cord stimulation or a dorsal root ganglion stimulation trial. Since January 2017, we implemented a Multidisciplinary Team Conference for Neuromodulation in our center to facilitate the collaboration between pain physicians and psychologists and to optimize screening of neuromodulation candidates. This study aims to report the impact of this team conference on improvement of neuromodulation outcome in our center. Methods Appropriateness of neuromodulation were discussed in the team conference after initial visit with the pain specialist and psychological evaluation. For this study, we prospectively and retrospectively collected data on neuromodulation candidates who went through the team conference and those who did not as controls. Results We discussed 461 patients in the team conference sessions from January 2017 to July 2023. Out of these, a spinal cord stimulator or a dorsal root ganglion stimulator trial was performed in 164 patients with 80.5% (132 cases) trial success rate leading to 140 implants. Out of these implants, 26 (18.6%) explanted and 21 (15%) required revision in 41 (29.3%) patients. We performed neuraxial neuromodulation trial for 70 patients without going through the team conference from January 2016 to July 2023 with a trial success rate of 45.7% (32 cases). In this group, 7 (21.9%) and 6 (18.8%) patients underwent explant and revision. The differences between the groups were statistically significant for trial success rate (odds ratio of 4.9 with p-value of <0.01) but not for explant (odds ratio of 0.8 with p-value of 0.627) or revision (odds ratio of 0.8 with p-value of 0.595). Conclusion Implementing Multidisciplinary Team Conference increased trial success rate in our center. Team conference provides therapeutic benefit for patients, and also provides the opportunity for an educational discussion for trainees.
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Affiliation(s)
- Vafi Salmasi
- Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, United States
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Koushik SS, Raghavan J, Saranathan S, Slinchenkova K, Viswanath O, Shaparin N. Complications of Spinal Cord Stimulators-A Comprehensive Review Article. Curr Pain Headache Rep 2024; 28:1-9. [PMID: 37855944 DOI: 10.1007/s11916-023-01178-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/03/2023] [Indexed: 10/20/2023]
Abstract
PURPOSE OF REVIEW Spinal cord stimulation has been increasing in influence as an option to regulate pain, especially in the chronic pain patient population. However, even with the numerous changes made to this technology since its inception, it is still prone to various complications such as hardware issues, neurological injury/epidural hematoma, infections, and other biological concerns. The purpose of this article is to thoroughly review and evaluate literature pertaining to the complications associated with percutaneous spinal cord stimulation. RECENT FINDINGS Lead migration is generally the most common complication of percutaneous spinal cord stimulation; however, recent utilization of various anchoring techniques has been discussed and experienced clinical success in decreasing the prevalence of lead migration and lead fractures. With newer high-frequency systems gaining traction to improve pain management and decrease complications as compared to traditional systems, rechargeable implantable pulse generators have been the preferred power source. However, recent findings may suggest that these rechargeable implantable pulse generators do not significantly increase battery life as much as was proposed. Intraoperative neuromonitoring has seen success in mitigating neurological injury postoperatively and may see more usage in the future through more testing. Though the occurrence of infection and biological complications, including dural puncture and skin erosion, has been less frequent over time, they should still be treated in accordance with established protocols. While many complications can arise following percutaneous spinal cord stimulator implantation, the procedure is less invasive than open implantation and has seen largely positive patient feedback. Hardware complications, the more common issues that can occur, rarely indicate a serious risk and can generally be remedied through reoperation. However, less common cases such as neurological injury, infections, and biological complications require prompt diagnosis to improve the condition of the patient and prevent significant damage.
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Affiliation(s)
- Sarang S Koushik
- Department of Anesthesiology, Valleywise Health Medical Center, Creighton University School of Medicine, Phoenix, AZ, USA.
| | - Jagun Raghavan
- Pre-Medical Student, Ohio State University, Columbus, OH, USA
| | | | - Kateryna Slinchenkova
- Department of Anesthesiology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA
| | - Omar Viswanath
- Innovative Pain and Wellness, LSU Health Sciences Center School of Medicine, Creighton University School of Medicine, Phoenix, AZ, USA
| | - Naum Shaparin
- Department of Anesthesiology, Albert Einstein College of Medicine, Bronx, NY, USA
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Su PYP, Arle J, Poree L. Closing the loop and raising the bar: Automated control systems in neuromodulation. Pain Pract 2024; 24:177-185. [PMID: 37638532 DOI: 10.1111/papr.13290] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/20/2023] [Accepted: 08/04/2023] [Indexed: 08/29/2023]
Abstract
INTRODUCTION Neuromodulation has emerged as a promising therapy for the management of chronic pain, movement disorders, and other neurological conditions. Spinal cord stimulation (SCS) is a widely used form of neuromodulation that involves the delivery of electrical impulses to the spinal cord to modulate the transmission of pain signals to the brain. In recent years, there has been increasing interest in the use of automation systems to improve the efficacy and safety of SCS. This narrative review summarizes the status of Food and Drug Administration-approved autonomous neuromodulation devices including closed loop, feedforward, and feedback systems. The review discusses the advantages and disadvantages of each system and focuses specifically on the use of these systems for SCS. It is important for clinicians to understand the expanding role of automation in neuromodulation in order to select appropriate therapies founded on automation systems to the specific needs of the patient and the underlying condition. CONCLUSION The review also provides insights into the current state of the art in neuromodulation automation systems and discusses potential future directions for research in this field.
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Affiliation(s)
- Po-Yi Paul Su
- Department of Anesthesia, University of California San Francisco, San Francisco, California, USA
| | | | - Lawrence Poree
- Department of Anesthesia, University of California San Francisco, San Francisco, California, USA
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McDonald CL, Alsoof D, Anderson G, Johnson K, Daniels AH. Spinal Cord Stimulators and Intrathecal Pain Pump Removal Versus Retention During Posterior Lumbar Fusion: A Matched Cohort Analysis. Clin Spine Surg 2023; 36:E430-E434. [PMID: 37482636 DOI: 10.1097/bsd.0000000000001502] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/10/2022] [Accepted: 06/21/2023] [Indexed: 07/25/2023]
Abstract
STUDY DESIGN Retrospective cohort study. OBJECTIVE To determine risks associated with posterior lumbar arthrodesis after spinal cord stimulator (SCS) and intrathecal pain pump (IPP) insertion. SUMMARY OF BACKGROUND DATA SCS and IPPs aid in the management of chronic back and radicular pain. Little is known regarding the risks of subsequent fusion with these devices in place. METHODS The PearlDiver Mariner database was queried for spinal fusion between 2010 and 2020. Study groups were created for indwelling SCS or IPP and matched to a separate cohort without SCS or IPP. Subgroups were created for those who had their device removed and those who retained their device at the time of surgery. Complications up to 2 years postoperatively were reviewed and confounding variables were controlled using multivariable logistic regression. RESULTS Four thousand five hundred three patients had an indwelling SCS/IPP and underwent posterior lumbar fusion. Compared with patients without history of an SCS/IPP, patients undergoing a lumbar fusion with an SCS/IPP which was removed or retained had higher rates of revision surgery at 1 year [7.3% vs. 5.0%, odds ratio (OR) =1.48, P <0.001] and 2 year (10.8% vs. 7.0%, OR =1.59, P <0.001). For all time intervals, there were higher odds of instrumentation failure (2 y: OR =1.65, P <0.001), and pulmonary complications (2 y: OR =1.18, P <0.001). At 2 years, there were higher odds of surgical site complications (OR 1.15, P =0.02) and urinary complications (OR=1.07, P =0.04). There were no differences in complications up to 2 years postoperatively in patients with an SCS/IPP who had their devices retained or removed ( P >0.05). CONCLUSIONS Patients with a history of spinal cord stimulators and intrathecal pain pumps are at increased risk of mechanical complications and revision fusion compared with patients without these devices. Patients with an SCS or IPP have similar rates of complications during lumbar fusion whether the device is removed or retained.
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Affiliation(s)
| | | | - George Anderson
- Warren Alpert Medical School of Brown University, Providence, RI
| | - Keir Johnson
- Warren Alpert Medical School of Brown University, Providence, RI
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Garg I, Wang D. Complications of Spinal Cord Stimulator Trials and Implants: A Review. Curr Pain Headache Rep 2023; 27:837-842. [PMID: 38010489 DOI: 10.1007/s11916-023-01190-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/16/2023] [Indexed: 11/29/2023]
Abstract
PURPOSE OF REVIEW Spinal cord stimulation (SCS) has been used for decades to alleviate chronic pain. A growing body of literature suggests that the procedure is not without risks. Understanding the risks of SCS implantation can help treating physicians formulate individualized care plans that promote patient safety and minimize risks. RECENT FINDINGS The overall complication rate associated with SCS has been reported to be 31.9 to 43%. The most common complication in the literature appears to be electrode migration. Other complications ranging in rates of occurrence include hematoma formation, infection, spinal cord injury, and cerebrospinal fluid (CSF) leak. Case reports of syrinx formation, foreign body reaction, and fibrosis have also been described. Our review shows that there are strategies available to reduce and prevent complications. In addition, close monitoring and early intervention may prevent some of the adverse neurological outcomes. Nevertheless, additional research regarding patient and procedural factors is necessary to improve the safety profile of this intervention.
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Affiliation(s)
- Ishan Garg
- Thomas Jefferson University Hospitals, Philadelphia, PA, USA
| | - Dajie Wang
- Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.
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Rigoard P, Ounajim A, Moens M, Goudman L, Roulaud M, Lorgeoux B, Baron S, Nivole K, Many M, Lampert L, David R, Billot M. Should we Oppose or Combine Waveforms for Spinal Cord Stimulation in PSPS-T2 Patients? A Prospective Randomized Crossover Trial (MULTIWAVE Study). THE JOURNAL OF PAIN 2023; 24:2319-2339. [PMID: 37473903 DOI: 10.1016/j.jpain.2023.07.015] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/01/2023] [Revised: 06/16/2023] [Accepted: 07/12/2023] [Indexed: 07/22/2023]
Abstract
Refractory persistent spinal pain syndrome after surgery (PSPS-T2) can be successfully addressed by spinal cord stimulation (SCS). While conventional stimulation generates paresthesia, recent systems enable the delivery of paresthesia-free stimulation. Studies have claimed non-inferiority/superiority of selected paresthesia-free stimulation compared with paresthesia-based stimulation, but the comparative efficacy between different waveforms still needs to be determined in a given patient. We designed a randomized controlled 3-month crossover trial to compare pain relief of paresthesia-based stimulation versus high frequency versus burst in 28 PSPS-T2 patients implanted with multiwave SCS systems. Our secondary objectives were to determine the efficacy of these 3 waveforms on pain surface, quality of life, functional capacity, psychological distress, and validated composite multidimensional clinical response index to provide holistic comparisons at 3-, 6-, 9-, and 15-month post-randomization. The preferred stimulation modality was documented during the follow-up periods. No difference between the waveforms was observed in this study (P = .08). SCS led to significant pain relief, quality of life improvement, improvement of multidimensional clinical response index, and of all other clinical outcomes at all follow-up visits. Forty-four percent of the patients chose to keep the paresthesia-based stimulation modality after the 15-month follow-up period. By giving the possibility to switch and/or to combine several waveforms, the overall rate of SCS responders further increased with 25%. In this study, high frequency or burst do not appear superior to paresthesia-based stimulation, wherefore paresthesia-based stimulation should still be considered as a valid option. However, combining paresthesia-based stimulation with paresthesia-free stimulation, through personalized multiwave therapy, might significantly improve SCS responses. PERSPECTIVE: This article assesses clinical SCS efficacy on pain relief, by comparing paresthesia-based stimulation and paresthesia-free stimulation (including high frequency and burst) modalities in patient presenting with PSPS-T2. Switching and/or combining waveforms contribute to increasing the global SCS responders rate.
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Affiliation(s)
- Philippe Rigoard
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Department of Neuro-Spine & Neuromodulation, Poitiers University Hospital, Poitiers, France; Pprime Institute UPR 3346, CNRS, ISAE-ENSMA, University of Poitiers, Chasseneuil-du-Poitou, France
| | - Amine Ounajim
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Maarten Moens
- Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; STIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium; Department of Radiology, Universitair Ziekenhuis Brussel, Brussels, Belgium
| | - Lisa Goudman
- Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; STIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium; Research Foundation-Flanders (FWO), Brussels, Belgium
| | - Manuel Roulaud
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Bertille Lorgeoux
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Sandrine Baron
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Kévin Nivole
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Mathilde Many
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Lucie Lampert
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
| | - Romain David
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France; Department of Physical and Rehabilitation Medicine Unit, Poitiers University Hospital, University of Poitiers, Poitiers, France
| | - Maxime Billot
- PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, France
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Kirketeig T, Söreskog E, Jacobson T, Karlsten R, Zethraeus N, Borgström F. Real-world outcomes in spinal cord stimulation: predictors of reported effect and explantation using a comprehensive registry-based approach. Pain Rep 2023; 8:e1107. [PMID: 38027468 PMCID: PMC10653578 DOI: 10.1097/pr9.0000000000001107] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/27/2023] [Revised: 09/04/2023] [Accepted: 09/23/2023] [Indexed: 12/01/2023] Open
Abstract
Introduction Despite advancements in implanted hardware and development of novel stimulation paradigms in Spinal Cord Stimulation (SCS), real world evidence suggests a large variation in patient reported outcomes and a proportion of patients are later explanted due to loss of analgesia. Possible predictors for outcome have been explored in smaller short-term evaluations, but few clinically applicable robust measures for long term outcome have emerged. Methods We performed a comprehensive retrospective study based on an assembled patient-level aggregated database from multiple local and national registries in Sweden. Variables associated with risk of explantation (due to insufficient analgesia) and analgesic effect was analyzed using a Cox regression analysis and an ordered logit regression model, respectively. Results We found the accumulated risk of explantation due to loss of analgesia to be 10% and 21% at two and ten years follow up, respectively. The use of 10 kHz spinal cord stimulation (compared with Tonic waveform; p = 0.003), and being 60 years or older (reference 18-40 years; p = 0.003) were associated with an increased risk of explantation.At a mean follow up at 1 year, 48% of patients reported a pain intensity reduction from baseline of at least 30%. Secondary (p = 0.030) and post-secondary (p = 0.001) education (compared with primary education) was associated with an increased probability of successful patient reported outcomes. Conclusion This study suggests that a higher educational level and being employed are associated with successful treatment outcome in patients with chronic pain treated with SCS in Sweden.
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Affiliation(s)
- Terje Kirketeig
- Akademiska Sjukhuset, Uppsala, Sweden
- Department of Surgical Sciences, Uppsala University, Uppsala, Sweden
| | - Emma Söreskog
- Quantify Research, Stockholm, Sweden
- Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden
| | | | - Rolf Karlsten
- Akademiska Sjukhuset, Uppsala, Sweden
- Department of Surgical Sciences, Uppsala University, Uppsala, Sweden
| | - Niklas Zethraeus
- Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Stockholm, Sweden
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Puylaert M, Nijs L, Buyse K, Vissers K, Vanelderen P, Nagels M, Daenekindt T, Weyns F, Mesotten D, Van Zundert J, Van Boxem K. Long-Term Outcome in Patients With Spinal Cord Stimulation for Failed Back Surgery Syndrome: A 20-Year Audit of a Single Center. Neuromodulation 2023; 26:1433-1440. [PMID: 35577695 DOI: 10.1016/j.neurom.2022.03.006] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/10/2021] [Revised: 03/14/2022] [Accepted: 03/28/2022] [Indexed: 11/24/2022]
Abstract
STUDY DESIGN This is a retrospective, observational study. INTRODUCTION Spinal cord stimulation (SCS) has found its application in chronic pain treatment, with failed back surgery syndrome (FBSS) as one of the most important indications. However, to date, little is known about the long-term effectiveness of the treatment. The aim of this study is to analyze retrospectively the long-term outcomes of SCS treatment in a single multidisciplinary pain center on predominant radicular pain, using devices of a single manufacturer. MATERIALS AND METHODS Patient data on overall patient satisfaction, pain intensity, and adverse events were retrospectively collected in our clinical practice between January 1998 and January 2018, for 191 patients who received a permanent SCS implant. Secondary health measures included the influence of opioid and nicotine use on pain reduction after therapy. RESULTS The trial-to-implant ratio was 93.6%. At a mean follow-up of 10.6 years, 78.5% of the patients were satisfied with the treatment outcome, with a significant pain reduction of an average three points on a Numeric Rating Scale. Opioid and nicotine usage did not have a significant link with the pain reduction one year after the treatment. Furthermore, devices had an average battery lifespan of 8.4 years. A total of 248 revisions were recorded. A total of 24 patients (11.7%) acquired an infection; 7 of 204 patients had an infection during the trial period, 2 of 191 patients had an infection in the first postoperative year, and 15 of 191 patients had an infection after the first year. The average time to infection, if not in the first year, was 10.1 years. CONCLUSIONS A successful long-term outcome regarding pain relief in patients with predominant radicular pain due to FBSS is established with SCS therapy.
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Affiliation(s)
- Martine Puylaert
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium; Department of Anesthesiology and Pain Management, University Medical Centre Maastricht, Maastricht, The Netherlands
| | - Lynn Nijs
- KU Leuven, Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, Leuven, Belgium
| | - Klaas Buyse
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium
| | - Kris Vissers
- Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Pascal Vanelderen
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium; Hasselt University and Limburg Clinical Research Center, Faculty of Medicine and Life Sciences, Diepenbeek, Belgium
| | - Margot Nagels
- Department of Medicine, Hasselt University, Hasselt, Belgium
| | | | - Frank Weyns
- Hasselt University and Limburg Clinical Research Center, Faculty of Medicine and Life Sciences, Diepenbeek, Belgium; Department of Neurosurgery, Ziekenhuis Oost-Limburg, Genk, Belgium
| | - Dieter Mesotten
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium; Hasselt University and Limburg Clinical Research Center, Faculty of Medicine and Life Sciences, Diepenbeek, Belgium
| | - Jan Van Zundert
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium; Department of Anesthesiology and Pain Management, University Medical Centre Maastricht, Maastricht, The Netherlands
| | - Koen Van Boxem
- Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Ziekenhuis Oost-Limburg, Genk, Belgium; Department of Anesthesiology and Pain Management, University Medical Centre Maastricht, Maastricht, The Netherlands.
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Russo MA, Volschenk W, Bailey D, Santarelli DM, Holliday E, Barker D, Dizon J, Graham B. A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, Dose-Response Study. Neuromodulation 2023; 26:1412-1423. [PMID: 37486284 DOI: 10.1016/j.neurom.2023.06.007] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/25/2023] [Revised: 06/08/2023] [Accepted: 06/18/2023] [Indexed: 07/25/2023]
Abstract
OBJECTIVES The aim of this prospective, single-blinded, dose-response study was to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites for the treatment of chronic neuropathic low back pain (LBP). MATERIALS AND METHODS Twenty-seven participants with chronic neuropathic LBP were implanted with a commercial SCS system after a successful trial of SCS therapy. Devices were programmed to deliver the investigative waveform (100 Hz, 1000 μs, T9/T10 bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 40%). Programs were evaluated at six, ten, and 14 weeks, after which participants selected their preferred program, with more follow-up at 26 weeks (primary outcomes). Participants were blinded to the nature of the programming. Pain score (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at baseline and follow-ups. Responder rate, treatment satisfaction, clinician global impression of change, and adverse events (AEs) also were evaluated. RESULTS Mean (± SD) baseline VAS was 72.5 ± 11.2 mm. At 26 weeks (n = 26), mean change from baseline in VAS was -51.7 mm (95% CI, -60.7 to -42.7; p < 0.001), with 76.9% of participants reporting ≥50% VAS reduction, and 46.2% reporting ≥80% VAS reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with their treatment. There were no unanticipated AEs related to the study intervention, device, or procedures. CONCLUSIONS This novel, paresthesia-free stimulation waveform may be a safe and effective option for patients with chronic neuropathic LBP eligible for SCS therapy and is deliverable by all current commercial SCS systems. CLINICAL TRIAL REGISTRATION This study is registered on anzctr.org.au with identifier ACTRN12618000647235.
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Affiliation(s)
- Marc A Russo
- Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia; University of Newcastle, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, Callaghan, New South Wales, Australia.
| | - Willem Volschenk
- Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia
| | - Dominic Bailey
- Genesis Research Services, Broadmeadow, New South Wales, Australia
| | | | - Elizabeth Holliday
- Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
| | - Daniel Barker
- Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
| | - Jason Dizon
- Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
| | - Brett Graham
- University of Newcastle, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, Callaghan, New South Wales, Australia
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Staats P, Deer TR, Hunter C, Li S, Dickerson D, Petersen E, Kapural L, Durbhakula S, Gilligan C, Slavin KV, Pope J, Amirdelfan K, Poree L, Naidu R, Levy RM. Remote Management of Spinal Cord Stimulation Devices for Chronic Pain: Expert Recommendations on Best Practices for Proper Utilization and Future Considerations. Neuromodulation 2023; 26:1295-1308. [PMID: 37632517 DOI: 10.1016/j.neurom.2023.07.003] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2023] [Revised: 06/12/2023] [Accepted: 07/06/2023] [Indexed: 08/28/2023]
Abstract
OBJECTIVE Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device management into the care of patients with SCS, including remote monitoring and remote programming. MATERIALS AND METHODS A panel of experts in SCS met in July 2022, and additional experts contributed to the development of recommendations after the meeting via survey responses and correspondence. RESULTS Major goals of remote SCS device management were identified, including prompt identification and resolution of SCS-related issues. The panel identified metrics for remote monitoring and classified them into three categories: device-related (eg, stimulation usage); measurable physiologic or disease-related (eg, patient physical activity or pedometry); and patient-reported (eg, sleep quality and pain intensity). Recommendations were made for frequency of reviewing remote monitoring metrics, although providers should tailor follow-up to individual patient needs. Such periodic reviews of remote monitoring metrics would occur separately from automatic monitoring system notifications (if key metrics fall outside an acceptable range). The guidelines were developed in consideration of reimbursement processes, privacy concerns, and the responsibilities of the care team, industry professionals, manufacturers, patients, and caregivers. Both existing and needed clinical evidence were covered, including outcomes of interest for future studies. CONCLUSIONS Given the expansion of SCS device capabilities, this document provides critical guidance on best practices for using remote device management, although medical necessity should drive all remote monitoring decisions, with individualized patient care. The authors also describe the potential of these emerging technologies to improve outcomes for patients with SCS, although more clinical evidence is needed.
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Affiliation(s)
- Peter Staats
- National Spine and Pain Centers, Rockville, MD, USA.
| | - Timothy R Deer
- Spine and Nerve Center of the Virginias, Charleston, WV, USA
| | - Corey Hunter
- Ainsworth Institute of Pain Management, New York, NY, USA
| | - Sean Li
- Premier Pain Centers (an affiliate of National Spine and Pain Centers), Shrewsbury, NJ, USA
| | - David Dickerson
- Department of Anesthesiology, Critical Care and Pain Medicine, NorthShore University HealthSystem, Evanston, IL, USA
| | - Erika Petersen
- Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA
| | | | - Shravani Durbhakula
- Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Christopher Gilligan
- Division of Pain Medicine, Brigham & Women's Hospital/Harvard Medical School, Boston, MA, USA
| | - Konstantin V Slavin
- Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL, USA; Neurology Section, Jesse Brown Veterans Administration Medical Center, Chicago, IL, USA
| | - Jason Pope
- Evolve Restorative Center, Santa Rosa, CA
| | | | - Lawrence Poree
- Neuromodulation Services, Division of Pain Medicine, Department of Anesthesia, University of California at San Francisco, San Francisco, CA, USA
| | - Ramana Naidu
- MarinHealth Spine Institute, a UCSF Affiliate, Larkspur, CA, USA
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Petersen EA, Stauss TG, Scowcroft JA, Jaasma MJ, Brooks ES, Edgar DR, White JL, Sills SM, Amirdelfan K, Guirguis MN, Xu J, Yu C, Nairizi A, Patterson DG, Tsoulfas KC, Creamer MJ, Galan V, Bundschu RH, Mehta ND, Sayed D, Lad SP, DiBenedetto DJ, Sethi KA, Goree JH, Bennett MT, Harrison NJ, Israel AF, Chang P, Wu PW, Argoff CE, Nasr CE, Taylor RS, Caraway DL, Mekhail NA. Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Diabetes Res Clin Pract 2023; 203:110865. [PMID: 37536514 PMCID: PMC10801706 DOI: 10.1016/j.diabres.2023.110865] [Citation(s) in RCA: 17] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/11/2023] [Revised: 06/30/2023] [Accepted: 07/31/2023] [Indexed: 08/05/2023]
Abstract
AIMS To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN). METHODS The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding. RESULTS At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection. CONCLUSIONS Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN. TRIAL REGISTRATION ClincalTrials.gov Identifier, NCT03228420.
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Affiliation(s)
- Erika A Petersen
- Department of Neurosurgery, University of Arkansas for Medical Sciences, 4301 W Markham St, Little Rock, AR 72205, USA.
| | - Thomas G Stauss
- Advanced Pain Management, 4131 W Loomis Rd Ste 300, Greenfield, WI 53221, USA
| | - James A Scowcroft
- Pain Management Associates, 200 NE Missouri Rd Ste 103, Lee's Summit, MO 64086, USA
| | | | | | | | - Judith L White
- AES Compass Orlando, 100 W Gore St, Orlando, FL 32806, USA
| | - Shawn M Sills
- Touchstone Interventional Pain Center, 2925 Siskiyou Blvd, Medford, OR 97504, USA
| | | | - Maged N Guirguis
- Ochsner Health System, 2820 Napoleon Ave, New Orleans, LA 70115, USA
| | - Jijun Xu
- Department of Pain Management, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA
| | - Cong Yu
- Swedish Medical Center, 1101 Madison St, Seattle, WA 98104, USA
| | - Ali Nairizi
- Nevada Advanced Pain Specialists, 5578 Longley Ln, Reno, NV 89511, USA
| | - Denis G Patterson
- Nevada Advanced Pain Specialists, 5578 Longley Ln, Reno, NV 89511, USA
| | | | - Michael J Creamer
- Central Florida Pain Relief Centers, 100 W Gore St #500, Orlando, FL 32806, USA
| | - Vincent Galan
- Pain Care, 1365 Rock Quarry Rd #301, Stockbridge, GA 30281, USA
| | - Richard H Bundschu
- Coastal Orthopedics and Sports Medicine, 8000 SR 64, Bradenton, FL 34212, USA
| | - Neel D Mehta
- Department of Anesthesiology, Weill Cornell Medical College, 240 East 59th Street, 2nd Floor, New York, NY 10022, USA
| | - Dawood Sayed
- Department of Anesthesiology and Pain Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA
| | - Shivanand P Lad
- Department of Neurosurgery, Duke University, 40 Duke Medicine Cir, Durham, NC 27710, USA
| | | | - Khalid A Sethi
- Department of Neurosurgery, United Health Services, 46 Harrison St, Johnson City, NY 13790, USA
| | - Johnathan H Goree
- Department of Anesthesiology, University of Arkansas for Medical Sciences, 4301 W Markham St, Little Rock, AR 72205, USA
| | - Matthew T Bennett
- Department of Neurosurgery, United Health Services, 46 Harrison St, Johnson City, NY 13790, USA
| | - Nathan J Harrison
- Ochsner Health System, 2820 Napoleon Ave, New Orleans, LA 70115, USA
| | - Atef F Israel
- Pain Management Associates, 200 NE Missouri Rd Ste 103, Lee's Summit, MO 64086, USA
| | - Paul Chang
- Pain Care, 1365 Rock Quarry Rd #301, Stockbridge, GA 30281, USA
| | - Paul W Wu
- Holy Cross Hospital, 5601 N Dixie Hwy #209, Fort Lauderdale, FL 33334, USA
| | - Charles E Argoff
- Department of Neurology, Albany Medical Center, 47 New Scotland Avenue, Albany, NY 12208, USA
| | - Christian E Nasr
- Division of Endocrinology, Department of Internal Medicine, The University of Arizona College of Medicine - Phoenix, 475 N 5th St, Phoenix, AZ 85004, USA
| | - Rod S Taylor
- MRC/CSO Social and Public Health Sciences Unit, Robertson Centre for Biostatistics, School of Health and Well Being, Clarice Pears Building, University of Glasgow, Glasgow, Scotland G12 8QQ, UK
| | | | - Nagy A Mekhail
- Evidence-Based Pain Management Research, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, USA
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49
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Durbhakula S, Toy S, Acosta CA, Barman RA, Kelner AF, Issa MA, Broachwala MY, Marascalchi BJ, Navalgund YA, Pak DJ, Petersen EA, Mehta ND, Moeschler SM, Kohan LR. Needs-based novel digital curriculum for the neuromodulation training deficit: Pain Rounds. Reg Anesth Pain Med 2023; 48:414-419. [PMID: 37055185 PMCID: PMC10359535 DOI: 10.1136/rapm-2023-104480] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/05/2023] [Accepted: 03/28/2023] [Indexed: 04/15/2023]
Abstract
This study reports the needs-based development, effectiveness and feasibility of a novel, comprehensive spinal cord stimulation (SCS) digital curriculum designed for pain medicine trainees. The curriculum aims to address the documented systematic variability in SCS education and empower physicians with SCS expertise, which has been linked to utilization patterns and patient outcomes. Following a needs assessment, the authors developed a three-part SCS e-learning video curriculum with baseline and postcourse knowledge tests. Best practices were used for educational video production and test-question development. The study period was from 1 February 2020 to 31 December 2020. A total of 202 US-based pain fellows across two cohorts (early-fellowship and late-fellowship) completed the baseline knowledge assessment, while 122, 96 and 88 participants completed all available post-tests for Part I (Fundamentals), Part II (Cadaver Lab) and Part III (Decision Making, The Literature and Critical Applications), respectively. Both cohorts significantly increased knowledge scores from baseline to immediate post-test in all curriculum parts (p<0.001). The early-fellowship cohort experienced a higher rate of knowledge gain for Parts I and II (p=0.045 and p=0.027, respectively). On average, participants viewed 6.4 out of 9.6 hours (67%) of video content. Self-reported prior SCS experience had low to moderate positive correlations with Part I and Part III pretest scores (r=0.25, p=0.006; r=0.37, p<0.001, respectively). Initial evidence suggests that Pain Rounds provides an innovative and effective solution to the SCS curriculum deficit. A future controlled study should examine this digital curriculum's long-term impact on SCS practice and treatment outcomes.
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Affiliation(s)
- Shravani Durbhakula
- Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
| | - Serkan Toy
- Departments of Basic Science Education and Health Systems & Implementation Science, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA
| | - Carlos A Acosta
- Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, USA
- Carey Business School, Johns Hopkins University, Baltimore, Maryland, USA
| | - Ross A Barman
- Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota, USA
| | | | | | - Mustafa Y Broachwala
- Department of Physical Medicine and Rehabilitation, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
| | - Bryan J Marascalchi
- Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA
| | | | - Daniel J Pak
- Department of Anesthesiology, Weill Cornell Medicine, New York, New York, USA
| | - Erika A Petersen
- Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA
| | - Neel D Mehta
- Department of Anesthesiology, Weill Cornell Medicine, New York, New York, USA
| | - Susan M Moeschler
- Department of Anesthesiology, Mayo Clinic, Rochester, Minnesota, USA
| | - Lynn R Kohan
- Department of Anesthesiology, University of Virginia, Charlottesville, Virginia, USA
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50
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Witkam RL, Kragt EAM, Arnts IJJ, Bronkhorst EM, van Dongen R, Kurt E, Steegers MAH, van Haren FGAM, Maandag NJG, Gort C, Henssen DJHA, Wegener JT, Vissers KCP. Spinal Cord Stimulation for Failed Back Surgery Syndrome: to Trial or Not to Trial? THE JOURNAL OF PAIN 2023; 24:1298-1306. [PMID: 36878384 DOI: 10.1016/j.jpain.2023.02.032] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/13/2022] [Revised: 02/16/2023] [Accepted: 02/27/2023] [Indexed: 03/07/2023]
Abstract
Spinal cord stimulation (SCS) is a recommended therapy to treat failed back surgery syndrome (FBSS). A trial period is practiced to enhance patient selection. However, its fundamental evidence is limited, especially concerning long-term benefit and therapy safety. We compared the long-term (5.3 ± 4.0 years) clinical outcome and therapy safety of a trialed and nontrialed implantation strategy, including multidimensional variables and pain intensity fluctuations over time. A multicenter cohort analysis was performed in 2 comparable groups of FBSS patients. Regarding eligibility, patients had to be treated with SCS for at least 3 months. While the Trial group comprised patients who underwent an SCS implantation after a successful trial, the No-Trial group encompassed patients who underwent complete implantation within 1 session. The primary outcome measures were pain intensity scores and complications. The Trial and No-Trial groups consisted of 194 and 376 patients (N = 570), respectively. A statistically but not clinically significant difference in pain intensity (P = .003; effect = 0.506 (.172-.839)) was found in favor of the Trial group. No interaction between a time dependency effect and pain intensity was noted. Whereas trialed SCS patients were more likely to cease opioid usage (P = .003; OR = .509 (.326-.792)), patients in the No-Trial group endured fewer infections (P = .006; proportion difference = .43 (.007-.083)). Although the clinical relevance of our findings should be proven in future studies, this long-term real-world data study indicates that patient-centered assessments on whether an SCS trial should be performed have to be investigated. According to the current ambiguous evidence, SCS trials should be considered on a case-by-case basis. PERSPECTIVE: The currently available comparative evidence, together with our results, remains ambiguous on which SCS implantation strategy might be deemed superior. An SCS trial should be considered on a case-by-case basis, for which further investigation of its clinical utility in certain patient populations or character traits is warranted.
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Affiliation(s)
- Richard L Witkam
- Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands.
| | - Elisabeth A M Kragt
- Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Inge J J Arnts
- Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Ewald M Bronkhorst
- Department of Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Robert van Dongen
- Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Erkan Kurt
- Department of Neurosurgery, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Monique A H Steegers
- Department of Anaesthesiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
| | - Frank G A M van Haren
- Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Natasja J G Maandag
- Department of Anaesthesiology, Sint Maartenskliniek, Ubbergen, The Netherlands
| | - Cees Gort
- Department of Anaesthesiology, Sint Maartenskliniek, Ubbergen, The Netherlands
| | - Dylan J H A Henssen
- Department of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands
| | - Jessica T Wegener
- Department of Anaesthesiology, Sint Maartenskliniek, Ubbergen, The Netherlands
| | - Kris C P Vissers
- Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands
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