Journal ArticleDOI
Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial
Nagy Mekhail,Robert M. Levy,Timothy R. Deer,Leonardo Kapural,Sean Li,Kasra Amirdelfan,Corey W. Hunter,Steven M. Rosen,Shrif Costandi,Steven M. Falowski,Abram H. Burgher,Jason E. Pope,Christopher A. Gilmore,Farooq A Qureshi,Peter S. Staats,James Scowcroft,Jonathan D. Carlson,Christopher Kim,Michael I Yang,Thomas Stauss,Lawrence Poree +20 more
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Greater spinal cord activation seen in the closed-loop group suggests a mechanistic explanation for the superior results, which aligns with the putative mechanism of action for spinal cord stimulation and warrants further investigation.Abstract:
Summary Background Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain. Methods This multicentre, double-blind, parallel-arm, randomised controlled trial was done at 13 specialist clinics, academic centres, and hospitals in the USA. Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm; Oswestry Disability Index [ODI] score 41–80) who were refractory to conservative therapy, on stable pain medications, had no previous experience with spinal cord stimulation, and were appropriate candidates for a spinal cord stimulation trial were screened. Eligible patients were randomly assigned (1:1) to receive ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group). The randomisation sequence was computer generated with permuted blocks of size 4 and 6 and stratified by site. Patients, investigators, and site staff were masked to the treatment assignment. The primary outcome was the proportion of patients with a reduction of 50% or more in overall back and leg pain with no increase in pain medications. Non-inferiority (δ=10%) followed by superiority were tested in the intention-to-treat population at 3 months (primary analysis) and 12 months (additional prespecified analysis) after the permanent implant. This study is registered with ClinicalTrials.gov , NCT02924129 , and is ongoing. Findings Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned (67 to each treatment group). The intention-to-treat analysis comprised 125 patients at 3 months (62 in the closed-loop group and 63 in the open-loop group) and 118 patients at 12 months (59 in the closed-loop group and 59 in the open-loop group). The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6–37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3–37·7; p=0·0060). We observed no differences in safety profiles between the two groups. The most frequently reported study-related adverse events in both groups were lead migration (nine [7%] patients), implantable pulse generator pocket pain (five [4%]), and muscle spasm or cramp (three [2%]). Interpretation ECAP-controlled closed-loop stimulation provided significantly greater and more clinically meaningful pain relief up to 12 months than open-loop spinal cord stimulation. Greater spinal cord activation seen in the closed-loop group suggests a mechanistic explanation for the superior results, which aligns with the putative mechanism of action for spinal cord stimulation and warrants further investigation. Funding Saluda Medical.read more
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Neuromodulation for chronic pain.
Helena Knotkova,Clement Hamani,Eellan Sivanesan,María Francisca Elgueta Le Beuffe,Jee Youn Moon,Steven P. Cohen,Steven P. Cohen,Marc A. Huntoon +7 more
TL;DR: In this article, the authors focus on spinal cord stimulation (SCS) therapies discussed within the framework of other invasive, minimally invasive, and non-invasive neuromodulation therapies.
Journal ArticleDOI
Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial
Sam Eldabe,Rui V. Duarte,Ashish Gulve,Simon Thomson,Ganesan Baranidharan,Rachel Houten,Sue Jowett,Harbinder Sandhu,Raymond Chadwick,Morag Brookes,Anu Kansal,Jenny Earle,Jill Bell,Jennifer Robinson,Sarah Walker,Shelley Rhodes,Rod S Taylor,Rod S Taylor +17 more
TL;DR: The TRIAL-STIM randomised controlled trial found no evidence that a spinal cord stimulation screening trial strategy provides superior patient outcomes compared to a no trial screening approach.
Journal ArticleDOI
Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain.
Michael A Fishman,Harold Cordner,Rafael Justiz,David A. Provenzano,Christopher Merrell,Binit Shah,Julian Naranjo,Philip Kim,Aaron K. Calodney,Jonathan D. Carlson,Richard Bundschu,Mahendra R Sanapati,Vipul Mangal,Ricardo Vallejo +13 more
TL;DR: Differential target multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain-related behavior and pain-relevant biological processes as mentioned in this paper.
Journal ArticleDOI
Mechanisms and mode of action of spinal cord stimulation in chronic neuropathic pain.
TL;DR: Mechanisms of stimulation of the DRG as well as those related to new SCS paradigms are now under investigation, where it seems that burst SCS not only stimulates sensory, discriminative aspects of pain (like Tonic SCS) but also emotional, affective, and motivational aspects ofPain.
Journal ArticleDOI
Explantation of 10 kHz Spinal Cord Stimulation Devices: A Retrospective Review of 744 Patients Followed for at Least 12 Months.
Jonathan M Hagedorn,Christopher M Lam,Ryan S D'Souza,Dawood Sayed,Markus A. Bendel,Chris Thuc Ha,Joshua Romero,Morgan Hall,Eric D. Freeman,Brian F Richardson,Bryan C. Hoelzer +10 more
TL;DR: In this article, the authors performed a retrospective chart review of all patients who received a 10 kHz-SCS implant before July 1, 2019 and found that the most common reason for explant was loss of efficacy, which accounted for 39 explants, 5.2% of total explants.
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TL;DR: The Global Burden of Diseases, Injuries, and Risk Factors Study 2016 (GBD 2016) provides a comprehensive assessment of prevalence, incidence, and years lived with disability (YLDs) for 328 causes in 195 countries and territories from 1990 to 2016.
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Global, regional, and national incidence, prevalence, andyears lived with disability for 354 diseases and injuries for195 countries and territories, 1990–2017: a systematicanalysis for the Global Burden of Disease Study 2017
Gbd Disease,Injury Incidence,Lorenzo Monasta,Luca Ronfani,Ettore Beghi,Giorgia Giussani,Boris Bikbov,Norberto Perico,Cristina Bosetti,Monica Cortinovis,Silvano Gallus,Giuseppe Remuzzi +11 more
TL;DR: All-cause age-standardised YLD rates decreased by 3·9% from 1990 to 2017; however, the all-age YLD rate increased by 7·2% while the total sum of global YLDs increased from 562 million (421–723) to 853 million (642–1100).
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Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)
Michael Herdman,Claire Gudex,Andrew Lloyd,Mathieu F. Janssen,Paul Kind,David Parkin,Gouke J. Bonsel,Xavier Badia +7 more
TL;DR: A 5-level version of the EQ-5D has been developed by the EuroQol Group and further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.