Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation

Introduction Intermittent dosing (ID), in which periods of stimulation‐on are alternated with periods of stimulation‐off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended...

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Veröffentlicht in:Neuromodulation (Malden, Mass.) Mass.), 2021-04, Vol.24 (3), p.566-573
Hauptverfasser: Deer, Timothy R., Patterson, Denis G., Baksh, Javid, Pope, Jason E., Mehta, Pankaj, Raza, Adil, Agnesi, Filippo, Chakravarthy, Krishnan V.
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container_issue 3
container_start_page 566
container_title Neuromodulation (Malden, Mass.)
container_volume 24
creator Deer, Timothy R.
Patterson, Denis G.
Baksh, Javid
Pope, Jason E.
Mehta, Pankaj
Raza, Adil
Agnesi, Filippo
Chakravarthy, Krishnan V.
description Introduction Intermittent dosing (ID), in which periods of stimulation‐on are alternated with periods of stimulation‐off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended stimulation‐off periods in patients with chronic intractable pain. Materials and Methods This prospective, multicenter, feasibility trial evaluated the clinical efficacy of the following ID stimulation‐off times: 90, 120, 150, and 360 sec with burst waveform parameters. After a successful trial (≥50% pain relief) using ID stimulation, subjects were titrated with OFF times beginning with 360 sec. Pain, quality of life, disability, and pain catastrophizing were evaluated at one, three, and six months after permanent implant. Results Fifty subjects completed an SCS trial using ID stimulation settings of 30 sec ON and 90 sec OFF, with 38 (76%) receiving ≥50% pain relief. Pain scores were significantly reduced from baseline at all time points (p 
doi_str_mv 10.1111/ner.13143
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The goal of this study was to evaluate the feasibility of using extended stimulation‐off periods in patients with chronic intractable pain. Materials and Methods This prospective, multicenter, feasibility trial evaluated the clinical efficacy of the following ID stimulation‐off times: 90, 120, 150, and 360 sec with burst waveform parameters. After a successful trial (≥50% pain relief) using ID stimulation, subjects were titrated with OFF times beginning with 360 sec. Pain, quality of life, disability, and pain catastrophizing were evaluated at one, three, and six months after permanent implant. Results Fifty subjects completed an SCS trial using ID stimulation settings of 30 sec ON and 90 sec OFF, with 38 (76%) receiving ≥50% pain relief. Pain scores were significantly reduced from baseline at all time points (p &lt; 0.001). Improvements in quality of life, disability, and pain catastrophizing were aligned with pain relief outcomes; 45.8% of the subjects that completed the six‐month follow‐up visit used an OFF period of 360 seconds. Conclusions ID burst SCS effectively relieved pain for six months. The largest group of subjects used IDB settings of 30 sec ON and 360 sec OFF. These findings present intriguing implications for the optimal “dose” of electricity in SCS and may offer many advantages such as optimizing the therapeutic window, extending battery life, reducing recharge burden and, potentially, mitigating therapy habituation or tolerance.</description><identifier>ISSN: 1094-7159</identifier><identifier>EISSN: 1525-1403</identifier><identifier>DOI: 10.1111/ner.13143</identifier><identifier>PMID: 32202044</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley &amp; Sons, Inc</publisher><subject>Chronic pain ; Chronic Pain - therapy ; Clinical Research ; cycling ; Dosage ; Habituation ; Humans ; intermittent dosing burst ; Pain ; Pain Management ; Prospective Studies ; Quality of Life ; Spinal Cord ; SPINAL CORD STIMULATION ; Treatment Outcome</subject><ispartof>Neuromodulation (Malden, Mass.), 2021-04, Vol.24 (3), p.566-573</ispartof><rights>2020 The Authors. published by Wiley Periodicals LLC on behalf of International Neuromodulation Society.</rights><rights>2020 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals LLC on behalf of International Neuromodulation Society.</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4433-56ffded7147edc7ccae5f3fdf6a06466715afa3b25546babf7d0b1a519aff22c3</citedby><cites>FETCH-LOGICAL-c4433-56ffded7147edc7ccae5f3fdf6a06466715afa3b25546babf7d0b1a519aff22c3</cites><orcidid>0000-0002-7994-3786 ; 0000-0003-1780-8084 ; 0000-0002-2431-7112</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32202044$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Deer, Timothy R.</creatorcontrib><creatorcontrib>Patterson, Denis G.</creatorcontrib><creatorcontrib>Baksh, Javid</creatorcontrib><creatorcontrib>Pope, Jason E.</creatorcontrib><creatorcontrib>Mehta, Pankaj</creatorcontrib><creatorcontrib>Raza, Adil</creatorcontrib><creatorcontrib>Agnesi, Filippo</creatorcontrib><creatorcontrib>Chakravarthy, Krishnan V.</creatorcontrib><title>Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation</title><title>Neuromodulation (Malden, Mass.)</title><addtitle>Neuromodulation</addtitle><description>Introduction Intermittent dosing (ID), in which periods of stimulation‐on are alternated with periods of stimulation‐off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended stimulation‐off periods in patients with chronic intractable pain. Materials and Methods This prospective, multicenter, feasibility trial evaluated the clinical efficacy of the following ID stimulation‐off times: 90, 120, 150, and 360 sec with burst waveform parameters. After a successful trial (≥50% pain relief) using ID stimulation, subjects were titrated with OFF times beginning with 360 sec. Pain, quality of life, disability, and pain catastrophizing were evaluated at one, three, and six months after permanent implant. Results Fifty subjects completed an SCS trial using ID stimulation settings of 30 sec ON and 90 sec OFF, with 38 (76%) receiving ≥50% pain relief. Pain scores were significantly reduced from baseline at all time points (p &lt; 0.001). Improvements in quality of life, disability, and pain catastrophizing were aligned with pain relief outcomes; 45.8% of the subjects that completed the six‐month follow‐up visit used an OFF period of 360 seconds. Conclusions ID burst SCS effectively relieved pain for six months. The largest group of subjects used IDB settings of 30 sec ON and 360 sec OFF. These findings present intriguing implications for the optimal “dose” of electricity in SCS and may offer many advantages such as optimizing the therapeutic window, extending battery life, reducing recharge burden and, potentially, mitigating therapy habituation or tolerance.</description><subject>Chronic pain</subject><subject>Chronic Pain - therapy</subject><subject>Clinical Research</subject><subject>cycling</subject><subject>Dosage</subject><subject>Habituation</subject><subject>Humans</subject><subject>intermittent dosing burst</subject><subject>Pain</subject><subject>Pain Management</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Spinal Cord</subject><subject>SPINAL CORD STIMULATION</subject><subject>Treatment Outcome</subject><issn>1094-7159</issn><issn>1525-1403</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNp1kVtLwzAYhoMoztOFf0AK3uhFXY5tdyNoPQ3GFKfXIW2TmdEmM2kn-_dGp0MFc5PA9_Dk_XgBOETwDIXTN9KdIYIo2QA7iGEWIwrJZnjDAY1TxAY9sOv9DEKUDnC6DXoEY4ghpTsgH9uFrKOhaaVrdNtK00ZX1mszjS4759voQThR6WkTaRNN5tqIOsqtq6JJq5uuFq22Zh9sKVF7efB174Hnm-un_C4e3d8O84tRXFJKSMwSpSpZpYimsirTshSSKaIqlQiY0CQJQYUSpMCM0aQQhUorWCDB0EAohXFJ9sD5yjvviiYoQlYnaj53uhFuya3Q_PfE6Bc-tQueYZriDAbByZfA2ddO-pY32peyroWRtvMckwxlNPyfBPT4DzqznQvbB4qFDTDGNAvU6YoqnfXeSbUOgyD_qIaHavhnNYE9-pl-TX53EYD-CnjTtVz-b-Lj68eV8h1hOJkq</recordid><startdate>202104</startdate><enddate>202104</enddate><creator>Deer, Timothy R.</creator><creator>Patterson, Denis G.</creator><creator>Baksh, Javid</creator><creator>Pope, Jason E.</creator><creator>Mehta, Pankaj</creator><creator>Raza, Adil</creator><creator>Agnesi, Filippo</creator><creator>Chakravarthy, Krishnan V.</creator><general>John Wiley &amp; 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Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Neuromodulation (Malden, Mass.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Deer, Timothy R.</au><au>Patterson, Denis G.</au><au>Baksh, Javid</au><au>Pope, Jason E.</au><au>Mehta, Pankaj</au><au>Raza, Adil</au><au>Agnesi, Filippo</au><au>Chakravarthy, Krishnan V.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation</atitle><jtitle>Neuromodulation (Malden, Mass.)</jtitle><addtitle>Neuromodulation</addtitle><date>2021-04</date><risdate>2021</risdate><volume>24</volume><issue>3</issue><spage>566</spage><epage>573</epage><pages>566-573</pages><issn>1094-7159</issn><eissn>1525-1403</eissn><abstract>Introduction Intermittent dosing (ID), in which periods of stimulation‐on are alternated with periods of stimulation‐off, is generally employed using 30 sec ON and 90 sec OFF intervals with burst spinal cord stimulation (SCS). The goal of this study was to evaluate the feasibility of using extended stimulation‐off periods in patients with chronic intractable pain. Materials and Methods This prospective, multicenter, feasibility trial evaluated the clinical efficacy of the following ID stimulation‐off times: 90, 120, 150, and 360 sec with burst waveform parameters. After a successful trial (≥50% pain relief) using ID stimulation, subjects were titrated with OFF times beginning with 360 sec. Pain, quality of life, disability, and pain catastrophizing were evaluated at one, three, and six months after permanent implant. Results Fifty subjects completed an SCS trial using ID stimulation settings of 30 sec ON and 90 sec OFF, with 38 (76%) receiving ≥50% pain relief. Pain scores were significantly reduced from baseline at all time points (p &lt; 0.001). Improvements in quality of life, disability, and pain catastrophizing were aligned with pain relief outcomes; 45.8% of the subjects that completed the six‐month follow‐up visit used an OFF period of 360 seconds. Conclusions ID burst SCS effectively relieved pain for six months. The largest group of subjects used IDB settings of 30 sec ON and 360 sec OFF. These findings present intriguing implications for the optimal “dose” of electricity in SCS and may offer many advantages such as optimizing the therapeutic window, extending battery life, reducing recharge burden and, potentially, mitigating therapy habituation or tolerance.</abstract><cop>Hoboken, USA</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>32202044</pmid><doi>10.1111/ner.13143</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-7994-3786</orcidid><orcidid>https://orcid.org/0000-0003-1780-8084</orcidid><orcidid>https://orcid.org/0000-0002-2431-7112</orcidid><oa>free_for_read</oa></addata></record>
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subjects Chronic pain
Chronic Pain - therapy
Clinical Research
cycling
Dosage
Habituation
Humans
intermittent dosing burst
Pain
Pain Management
Prospective Studies
Quality of Life
Spinal Cord
SPINAL CORD STIMULATION
Treatment Outcome
title Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation
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