ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial

Regional Anesthesia & Pain Medicine, Journal Year: 2023, Volume and Issue: unknown, P. rapm - 104751

Published: Aug. 27, 2023

Introduction The evidence for spinal cord stimulation (SCS) has been criticized the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations long-term effects SCS in RCTs. aim this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop (CL-SCS) is associated with better outcomes when compared fixed-output, open-loop (OL-SCS) 36 months following implant. Methods EVOKE a multicenter, participant-blinded, investigator-blinded, outcome assessor-blinded, randomized, controlled, parallel-arm clinical trial that ECAP-controlled CL-SCS fixed-output OL-SCS. Participants chronic, intractable back leg pain refractory conservative therapy were enrolled between January 2017 February 2018, follow-up through months. primary reduction at least 50% overall pain. Holistic treatment response, composite including intensity, physical emotional functioning, sleep, health-related quality life, objective neural activation also assessed. Results At months, more than OL-SCS participants reported ≥50% (CL-SCS=77.6%, OL-SCS=49.3%; difference: 28.4%, 95% CI 12.8% 43.9%, p<0.001) ≥80% (CL-SCS=49.3%, OL-SCS=31.3%; 17.9, 1.6% 34.2%, p=0.032) intensity. Clinically meaningful improvements from baseline observed both groups all other patient-reported greater levels improvement CL-SCS. A proportion patients holistic responders 36-month (44.8% vs 28.4%), cumulative responder score patients. Greater accuracy There no differences adverse events. No explants due loss efficacy group. Conclusion This evaluation measurement demonstrated resulted sustained, durable relief superior response increased delivery Trial registration number NCT02924129 .

Language: Английский

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Neuromodulation in chronic pain management: addressing persistent doubts in spinal cord stimulation

Journal of Anesthesia Analgesia and Critical Care, Journal Year: 2025, Volume and Issue: 5(1)

Published: Jan. 6, 2025

Language: Английский

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Feasibility of collecting objective data and exploring patient's experiences on physical activity in persistent spinal pain syndrome type 2 patients receiving spinal cord stimulation: A mixed feasibility study

Pain Practice, Journal Year: 2025, Volume and Issue: 25(3)

Published: Feb. 18, 2025

Abstract Background Patients with chronic pain due to persistent spinal syndrome Type 2 (PSPS 2) experience daily limitations in their physical activities. Physical, emotional, and social well‐being changes are usually measured standardized, validated self‐reporting questionnaires. These reported data subjective answered at a particular moment, which may not accurately reflect the patient's overall condition. Moreover, questionnaires could be misinterpreted, leading potential inaccuracies data. This highlights need for objective measurement tools that report longitudinal real‐life data, helpful evaluating activity cord stimulation (SCS). However, SCS therapy scarce. Objective We aimed investigate feasibility of collecting from an tracker neurostimulator device evaluate activity. As this is study, we also experiences participating patients healthcare professionals explore viability practicality future studies. Methods performed mixed‐methods study quantitative qualitative collection. Alongside standardized questionnaires, collected on different bodily functions as by body positions device, starting 1 month before trial follow‐up 3 months. Additionally, face‐to‐face, in‐depth interviews exploring patients' using six dimensions diagram positive health topic list. At end were asked five‐point Likert scale expressing satisfaction. The was two Dutch hospitals. Results included 20 PSPS 2, whom 17 (85%) completed three‐month nearly complete personalized real‐time set. Most missing wear watch. One patient developed allergic reaction watch strap. According interviews, mentioned feeling motivated physically active wearing tracker. evaluation form showed 84% 75% very satisfied would participate similar design. remotely baseline, trial, follow‐up. Conclusion Collecting activities status receiving appeared feasible neuromodulation if correctly worn wrist or clear instructions. add value holistic outcomes. Participating supported prospective

Language: Английский

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Should we Oppose or Combine Waveforms for Spinal Cord Stimulation in PSPS-T2 Patients? A Prospective Randomized Crossover Trial (MULTIWAVE Study)

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

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Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements With Closed-Loop Spinal Cord Stimulation

Neuromodulation Technology at the Neural Interface, Journal Year: 2024, Volume and Issue: unknown

Published: Sept. 1, 2024

Spinal cord stimulation (SCS) has been challenged by the lack of neurophysiologic data to guide therapy optimization. Current SCS programming trial-and-error results in suboptimal and variable therapeutic effects. A novel system with a physiologic closed-loop feedback mechanism using evoked-compound action potentials enables optimization neural dose consistently accurately activating spinal fibers. We aimed identify metrics their ranges that resulted clinically meaningful treatment responses.

Language: Английский

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Factors Predicting Clinically Relevant Pain Relief After Spinal Cord Stimulation for Patients With Chronic Low Back and/or Leg Pain: A Systematic Review With Meta-Analysis and Meta-Regression

Neuromodulation Technology at the Neural Interface, Journal Year: 2024, Volume and Issue: 27(1), P. 70 - 82

Published: Jan. 1, 2024

RationaleTo optimize results with spinal cord stimulation (SCS) for chronic low back pain (CLBP) and/or leg pain, including persistent syndrome (PSPS), careful patient selection based on proved predictive factors is essential. Unfortunately, the necessary process required to outcomes of SCS remains challenging.ObjectiveThis review aimed evaluate clinically relevant relief after patients CLBP radicular PSPS.Materials and MethodsIn August 2023, PubMed, Cinahl, Cochrane, EMBASE were searched identify studies published between January 2010 2023. Studies reporting percentage ≥50% in PSPS at 12 or 24 months, included. Meta-analysis was conducted pool back, leg, general relief. Predictive months examined using univariable multivariable meta-regression.ResultsA total 27 (2220 patients) included further analysis. The mean percentages substantial 68% 63% 73% follow-up, 59% 71% follow-up assessment. implantation method baseline Oswestry Disability Index made meta-regression model Sex duration final Variable relief.ConclusionsThis supports as an effective pain-relieving treatment models developed predict To provide high-grade evidence factors, high quality are needed which standardized success, in-patient improvements, monitored reported.

Language: Английский

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Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement

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

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Emotional and psychosocial function after dorsal column spinal cord stimulator implantation: a systematic review and meta-analysis

Regional Anesthesia & Pain Medicine, Journal Year: 2024, Volume and Issue: unknown, P. rapm - 105523

Published: June 27, 2024

Background The efficacy of spinal cord stimulation (SCS) in chronic pain studies is traditionally assessed by scores, which do not reflect the multidimensional nature perception. Despite evidence SCS’s influence on emotional functioning comprehensive assessments its effect remain lacking. Objective To assess changes and psychosocial patients who underwent SCS implantation for pain. Evidence review Ovid MEDLINE, EMBASE, PsychINFO, Cochrane CENTRAL Scopus databases were searched original peer-reviewed publications reporting after SCS. primary outcomes a pooled mean difference (MD) anxiety, depression, global functioning, mental well-being catastrophizing at 12 months. Grading Recommendation, Assessment, Development, Evaluation (GRADE) was used to determine quality evidence. Findings Thirty-two included analysis. Statistically significant improvements observed anxiety (MD −2.16; 95% CI −2.84 −1.49; p<0.001), depression −4.66; −6.26 −3.06; 20.30; 14.69 25.90; 4.95; 3.60 6.31; −12.09; −14.94 −9.23; p<0.001). Subgroup analyses revealed differences Global Assessment Functioning based study design waveform paradigm. Conclusion results highlight statistically clinically with undergoing therapy. However, these need be interpreted caution due very low certainty per GRADE criteria. PROSPERO registration CRD42023446326.

Language: Английский

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Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population

Pain and Therapy, Journal Year: 2024, Volume and Issue: 13(5), P. 1119 - 1136

Published: July 2, 2024

Closed-loop spinal cord stimulation (CL-SCS) is a recently introduced system that records evoked compound action potentials (ECAPs) from the elicited by each pulse and uses this information to automatically adjust strength in real time, known as ECAP-controlled SCS. This innovative compensates for fluctuations distance between epidural leads maintaining neural response (ECAP) at predetermined target level. data collection study was designed assess performance of first CL-SCS real-world setting under normal conditions use multiple European centers. The analyzes presents clinical outcomes electrophysiological device compares these findings with those reported earlier pre-market studies same system. prospective, multicenter, observational conducted 13 centers aimed gather data. focused on application treating chronic pain affecting trunk and/or limbs, adhering standard use. In addition collecting analyzing basic demographic information, inaugural patient cohort permanently implanted A significant decrease intensity observed overall back or leg scores (verbal numerical rating score [VNRS]) baseline (mean ± error mean [SEM]; n = 135; 8.2 0.1), 3 months (n 93; 2.3 0.2), 6 82; 2.5 0.3), 12 76; 0.3). Comparison relief (%) AVALON EVOKE showed no differences release (RWE; 71.3%; 69.6%) (71.2%; 73.6%) (78.1%; 76.7%) studies. Further investigation undertaken objectively characterize physiological parameters SCS therapy using metrics percent time above ECAP threshold (%), dose ratio, accuracy (µV), according previously described methods. Results median 90% (40.7–99.2) stimuli were threshold, ratio 1.3 (1.1–1.4) 4.4 µV (0.0–7.1), based 236, 230, 254 patients, respectively. Thus, across all three metrics, majority patients had objective corresponding highest levels (usage over > 80%, 1.2, < 10 µV). conclusion, provides valuable insights into system, highlighting its potential effective neurophysiological seen randomized control trials, quantifying burden associated via patient–device interaction metrics. Netherlands, duly registered International Clinical Trials Registry Platform (Trial NL7889). Germany, NCT05272137 United Kingdom ISCRTN27710516 has been reviewed ethics committee both countries.

Language: Английский

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Is There a Correlation Between Objective Measurement Tools and Self-Reporting Questionnaires To Evaluate Physical Activity and Health Status in Patients With Persistent Spinal Pain Syndrome Type 2 Before and After Spinal Cord Stimulation? Outcomes of a Feasibility Study

Neuromodulation Technology at the Neural Interface, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 1, 2025

Language: Английский

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