Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial DOI Creative Commons
Leonardo Kapural, Nagy Mekhail, Shrif Costandi

et al.

Regional Anesthesia & Pain Medicine, Journal Year: 2023, Volume and Issue: 49(4), P. 233 - 240

Published: July 25, 2023

Introduction Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials chronic interventions, however, remains primarily focused on treatment effects intensity. This study investigates a novel, multidimensional holistic response to evoked compound action potential-controlled closed-loop versus open-loop spinal cord stimulation as well the degree neural activation that produced response. Methods Outcome data for intensity, physical function, quality life, sleep emotional function were derived from individual patient level EVOKE multicenter, participant, investigator, outcome assessor-blinded, parallel-arm randomized controlled trial with 24 month follow-up. Evaluation considered whether baseline score was worse than normative values minimal important differences reached each domains impaired at baseline. A cumulative responder calculated reflect total accumulated across all Objective neurophysiological data, including measured. Results Patients (n=67) or (n=67). greater proportion (49.3% vs 26.9%) responders 24-month follow-up, least one difference (absolute risk difference: 22.4%, 95% CI 6.4% 38.4%, p=0.012). significantly time points resulted achievement more three additional follow-up (mean 3.4, 1.3 5.5, p=0.002). Neural times accurate (p<0.001 points). Conclusion results this suggest can provide sustained clinically meaningful improvements improvement long-term refractory pain. Trial registration number NCT02924129 .

Language: Английский

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial DOI Creative Commons
Anuj Bhatia, Jamal Kara, Tahir Janmohamed

et al.

JMIR mhealth and uhealth, Journal Year: 2021, Volume and Issue: 9(3), P. e26528 - e26528

Published: March 4, 2021

Chronic pain imposes a large burden on individuals and society. A patient-centric digital chronic management app called Manage My Pain (MMP) can be used to enhance communication between providers patients promote self-management.The purpose of this study was evaluate the real-world engagement in urban rural settings Ontario, Canada with MMP alongside their standard care assess impact its usage clinical outcomes related mental health.A total 246 participants at 2 clinics were recruited into prospective, open-label, exploratory that compared use MMP, health for incorporates validated questionnaires provides summarized reports progress combination (app group), against data entered paper-based (nonapp group). Participants completed anxiety, depression, catastrophizing, satisfaction, daily opioid consumption up 4.5 months after initial visit (short-term follow-up) 7 (long-term follow-up). Engagement two groups.A 73.6% (181/246) agreed app, 63.4% (111/175) them using it least one month. Individuals who rated lower anxiety (reduction Generalized Anxiety Disorder 7-item questionnaire score by 2.10 points, 95% CI -3.96 -0.24) short-term follow-up had greater reduction catastrophizing Catastrophizing Scale 5.23 -9.55 -0.91) long-term relative did not engage app.The is associated improvements self-reported catastrophizing. Further research required understand factors continued pain.ClinicalTrials.gov NCT04762329; https://clinicaltrials.gov/ct2/show/NCT04762329.

Language: Английский

Citations

61

Holistic Treatment Response: An International Expert Panel Definition and Criteria for a New Paradigm in the Assessment of Clinical Outcomes of Spinal Cord Stimulation DOI Creative Commons
Robert M. Levy, Nagy Mekhail, Alaa Abd‐Elsayed

et al.

Neuromodulation Technology at the Neural Interface, Journal Year: 2023, Volume and Issue: 26(5), P. 1015 - 1022

Published: Jan. 4, 2023

BackgroundTreatment response to spinal cord stimulation (SCS) is focused on the magnitude of effects pain intensity. However, chronic a multidimensional condition that may affect individuals in different ways and as such it seems reductionist evaluate treatment based solely unidimensional measure intensity.AimThe aim this article add framework started by IMMPACT for assessing wider health impact with SCS people pain, "holistic response".DiscussionSeveral aspects need consideration assessment holistic response. device data how relates patient outcomes, essential improve understanding types SCS, selection, long-term clinical reproducibility findings. The outcomes include evaluation consider relevance patients clinicians. Assessment combines two key concepts assessment: (1) level baseline (pre-treatment) unmet across range domains; (2) demonstration patient-relevant improvements these domains treatment. minimal important difference (MCID) an established approach reflect changes after intervention are meaningful can be used identify each individual domain. A needs account MCIDs all importance which presents dysfunctional scores pre-treatment. number included vary should considered basis. Physiologic confirmation therapy delivery utilisation part advance field increase transparency

Language: Английский

Citations

33

Machine learning predicts spinal cord stimulation surgery outcomes and reveals novel neural markers for chronic pain DOI Creative Commons

Jay Gopal,

Jonathan Bao, Tessa Harland

et al.

Scientific Reports, Journal Year: 2025, Volume and Issue: 15(1)

Published: March 18, 2025

Spinal cord stimulation (SCS) is a well-accepted therapy for refractory chronic pain. However, predicting responders remain challenge due to lack of objective pain biomarkers. The present study applies machine learning predict which patients will respond SCS based on intraoperative electroencephalogram (EEG) data and recognized outcome measures. included 20 who were undergoing surgery. During monitoring, EEG signals recorded under OFF (baseline) ON conditions, including tonic high density (HD) stimulation. Once spectral features extracted during offline analysis, principal component analysis (PCA) recursive feature elimination approach used selection. A subset features, clinical characteristics the preoperative patient reported measures (PROMs) build predictive model. Responders nonresponders grouped 50% reduction in 3-month postoperative Numeric Rating Scale (NRS) scores. two groups had no statistically significant differences with respect demographics (including age, diagnosis, location) or PROMs, except NRS (worst pain: p = 0.028; average < 0.001) Oswestry Disability Index scores (ODI, 0.030). Alpha-theta peak power ratio differed significantly between CP3-CP4 T3-T4 (p 0.019), lowest activity decision tree model performed best, achieving 88.2% accuracy, an F1 score 0.857, area curve (AUC) receiver operating characteristic (ROC) 0.879. Our findings suggest that combination subjective self-reports, intraoperatively obtained EEGs, well-designed algorithms might be potentially distinguish nonresponders. Machine deep hold enormous potential responses resulting refined selection improved outcomes.

Language: Английский

Citations

1

Patient Selection for Spinal Cord Stimulation in Treatment of Pain: Sequential Decision-Making Model — A Narrative Review DOI Creative Commons
Lisa Goudman, Philippe Rigoard, Maxime Billot

et al.

Journal of Pain Research, Journal Year: 2022, Volume and Issue: Volume 15, P. 1163 - 1171

Published: April 1, 2022

Abstract: Despite the well-known efficacy of spinal cord stimulation (SCS) in chronic pain management, patient selection clinical practice remains challenging. The aim this review is to provide an overview factors that can influence process for SCS treatment. A sequential decision-making model presented within a tier system operates practice. first level incorporates underlying disease as primary indication SCS, country-related reimbursement rules, and screening–trial criteria combination with psychological initial evaluating eligibility SCS. second aligned individualized approach precision medicine, whereby individual goals expectations potential need preoperative optimizations are emphasized. Additionally, relies on results from prediction models estimate long term. In third tier, bias, MRI compatibility, ethical beliefs included, together recent technological innovations, superiority specific paradigms, new feedback systems could indirectly physician. Both patients physicians should be aware different aspects relation management make independent decision whether or not initiate treatment trajectory Keywords: selection, decision-making, neuromodulation, experience-based medicine

Language: Английский

Citations

33

Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain DOI
Harsha Shanthanna, Sam Eldabe, David Provenzano

et al.

Regional Anesthesia & Pain Medicine, Journal Year: 2023, Volume and Issue: 48(6), P. 273 - 287

Published: March 30, 2023

Spinal cord stimulation (SCS) has demonstrated effectiveness for neuropathic pain. Unfortunately, some patients report inadequate long-term pain relief. Patient selection is emphasized this therapy; however, the prognostic capabilities and deployment strategies of existing techniques, including an SCS trial, have been questioned. After approval by Board Directors American Society Regional Anesthesia Pain Medicine, a steering committee was formed to develop evidence-based guidelines patient role trial. Representatives professional organizations with clinical expertize were invited participate as members. A comprehensive literature review carried out committee, results organized into narrative reports, which circulated all Individual statements recommendations within each seven sections formulated members voting. We used modified Delphi method wherein drafts member in blinded fashion Comments incorporated subsequent revisions, recirculated voting achieve consensus. Seven total 39 approved 100% consensus from Sections included definitions terminology trial; benefits screening psychosocial characteristics; perceptions on therapy use other predictors conduct trials; evaluation trials minimum criteria success. Recommendations that trial should be performed before definitive implant except anginal (grade B). All must screened objective validated instrument factors, include depression Despite limitations, helps provides opportunity experience therapy. These are expected guide practicing physicians stakeholders not mistaken practice standards. Physicians continue make their best judgment based individual considerations preferences.

Language: Английский

Citations

21

Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial DOI Creative Commons
Timothy R. Deer, Christopher Gilligan, Steven Falowski

et al.

Neuromodulation Technology at the Neural Interface, Journal Year: 2023, Volume and Issue: 26(7), P. 1387 - 1399

Published: Aug. 28, 2023

Spinal cord stimulation (SCS) is effective for relieving chronic intractable pain conditions. The Dorsal spInal STImulatioN vs mediCal management the Treatment of low back study evaluates effectiveness SCS compared with conventional medical (CMM) in treatment patients who had not undergone and were candidates lumbar spine surgery.

Language: Английский

Citations

17

Gradation of Clinical Holistic Response as New Composite Outcome to Evaluate Success in Spinal Cord Stimulation Studies for Pain DOI
Lisa Goudman, Maxime Billot, Rui Duarte

et al.

Neuromodulation Technology at the Neural Interface, Journal Year: 2022, Volume and Issue: 26(1), P. 139 - 146

Published: Jan. 3, 2022

Language: Английский

Citations

27

Should we Oppose or Combine Waveforms for Spinal Cord Stimulation in PSPS-T2 Patients? A Prospective Randomized Crossover Trial (MULTIWAVE Study) DOI Creative Commons
Philippe Rigoard, Amine Ounajim, Maarten Moens

et al.

Journal of Pain, Journal Year: 2023, Volume and Issue: 24(12), P. 2319 - 2339

Published: July 18, 2023

Refractory persistent spinal pain syndrome after surgery (PSPS-T2) can be successfully addressed by cord stimulation (SCS). While conventional generates paresthesia, recent systems enable the delivery of paresthesia-free stimulation. Studies have claimed non-inferiority/superiority selected compared with paresthesia-based stimulation, but comparative efficacy between different waveforms still needs to determined in a given patient. We designed randomized controlled 3-month crossover trial compare relief versus high frequency burst 28 PSPS-T2 patients implanted multiwave SCS systems. Our secondary objectives were determine these 3 on surface, quality life, functional capacity, psychological distress, and validated composite multidimensional clinical response index provide holistic comparisons at 3-, 6-, 9-, 15-month post-randomization. The preferred modality was documented during follow-up periods. No difference observed this study (P = .08). led significant relief, life improvement, improvement index, all other outcomes visits. Forty-four percent chose keep period. By giving possibility switch and/or combine several waveforms, overall rate responders further increased 25%. In study, or do not appear superior wherefore should considered as valid option. However, combining through personalized therapy, might significantly improve responses. PERSPECTIVE: This article assesses comparing (including burst) modalities patient presenting PSPS-T2. Switching contribute increasing global rate.

Language: Английский

Citations

16

Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement DOI Creative Commons
Johnathan Goree, Stuart A. Grant, David Dickerson

et al.

Neuromodulation Technology at the Neural Interface, Journal Year: 2024, Volume and Issue: 27(5), P. 847 - 861

Published: May 11, 2024

ObjectivesTotal knee arthroplasty (TKA) is an effective surgery for end-stage osteoarthritis, but chronic postoperative pain and reduced function affect up to 20% of patients who undergo such surgery. There are limited treatment options, percutaneous peripheral nerve stimulation (PNS) a promising nonopioid option chronic, persistent pain. The objective the present study was evaluate effect 60-day PNS in multicenter, randomized, double-blind, placebo-controlled trial treating after TKA.Materials MethodsPatients with replacement were screened this postmarket, institutional review board-approved, prospectively registered (NCT04341948) trial. Subjects randomized receive either active or placebo (sham) stimulation. designated evaluator blinded group assignments. both groups underwent ultrasound-guided placement fine-wire coiled leads targeting femoral sciatic nerves on leg Leads indwelling eight weeks, primary efficacy outcome compared proportion subjects each reporting ≥50% reduction average relative baseline during weeks five eight. Functional outcomes (6-minute walk test; 6MWT Western Ontario McMaster Universities Osteoarthritis Index) quality life (Patient Global Impression Change) also evaluated at end (EOT).ResultsA greater (60%; 12/20) than (24%; 5/21) responded relief (p = 0.028) endpoint (weeks 5–8). walked significantly distance EOT did those (6MWT; +47% vs −9% change from baseline; p 0.048, n 18 20 completed test, respectively). Prospective follow-up 12 months ongoing.ConclusionsThis provides evidence that decreases pain, which improved functional TKA EOT.

Language: Английский

Citations

5

A Novel Multi-Dimensional Clinical Response Index Dedicated to Improving Global Assessment of Pain in Patients with Persistent Spinal Pain Syndrome after Spinal Surgery, Based on a Real-Life Prospective Multicentric Study (PREDIBACK) and Machine Learning Techniques DOI Open Access
Philippe Rigoard, Amine Ounajim, Lisa Goudman

et al.

Journal of Clinical Medicine, Journal Year: 2021, Volume and Issue: 10(21), P. 4910 - 4910

Published: Oct. 24, 2021

The multidimensionality of chronic pain forces us to look beyond isolated assessment such as intensity, which does not consider multiple key parameters, particularly in post-operative Persistent Spinal Pain Syndrome (PSPS-T2) patients. Our ambition was produce a novel Multi-dimensional Clinical Response Index (MCRI), including only intensity but also functional capacity, anxiety-depression, quality life and quantitative mapping, the objective being achieve instantaneous using machine learning techniques. Two hundred PSPS-T2 patients were enrolled real-life observational prospective PREDIBACK study with 12-month follow-up received various treatments. From multitude questionnaires/scores, specific items combined, exploratory factor analyses helped create single composite MCRI; pairwise correlations between measurements, it appeared more accurately represent all dimensions than any previous classical score. It represented best compromise among existing indexes, showing highest sensitivity/specificity related Patient Global Impression Change (PGIC). Novel indexes could help refine by informing physician's perception patient condition on basis holistic metrics, providing new insights regarding therapy efficacy/patient outcome assessments, before ultimately adapted other pathologies.

Language: Английский

Citations

30