Validation of a holistic composite outcome measure for the evaluation of chronic pain interventions DOI Creative Commons
Rod S Taylor, Quinton Neville, Christopher M. Mullin

et al.

PAIN Reports, Journal Year: 2024, Volume and Issue: 9(6), P. e1202 - e1202

Published: Oct. 14, 2024

Abstract Introduction: Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using intensity measure alone to assess the effectiveness of chronic intervention fails fully evaluate its impact on multifaceted experience. The holistic minimal clinically important difference (MCID) composite outcome developed provide comprehensive assessment in response intervention, across 5 domains: intensity, health-related quality life, sleep quality, physical, and emotional function. To focus domains where individual need greatest, MCID reflects cumulative averaged over only subjects were impaired preintervention. Objectives: internal construct validity Holistic score inform future use as an evidence-based tool. Methods: This validation study was undertaken using data from EVOKE trial with 111 patients up 24-month follow-up. Internal consistency assessed Cronbach alpha statistic dimensional exploration principal component analysis. Results: demonstrated strong >0.7 at all follow-ups. Principal analysis showed one overarching dimension be present composite. Construct increase being associated both increased Patients' Global Impression Change, EuroQol visual analogue scale score, each “leave-one-out” (all P < 0.001). Conclusion: provides valid for comprehensive, personalized after intervention. requires further confirmation other populations different interventions.

Language: Английский

Maximal Analgesic Effect Attained by the Use of Objective Neurophysiological Measurements With Closed-Loop Spinal Cord Stimulation DOI Creative Commons
Robert M. Levy, Nagy Mekhail, Leonardo Kapural

et al.

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

Citations

6
The American Society of Pain and Neuroscience (ASPN) Guidelines and Consensus on the Definition, Current Evidence, Clinical Use and Future Applications for Physiologic Closed-Loop Controlled Neuromodulation in Chronic Pain: A NEURON Group Project DOI Creative Commons
Jason E. Pope, Timothy R. Deer, Dawood Sayed

et al.

Journal of Pain Research, Journal Year: 2025, Volume and Issue: Volume 18, P. 531 - 551

Published: Feb. 1, 2025

Introduction: Neuromodulation has been a staple of treatment for moderate-to-severe chronic refractory pain since the introduction first spinal cord stimulator by Norman Shealy in 1967. Appreciating dynamic nature electrical modulation nervous system from epidural space, goal consistent, reliable, and therapeutic neural activation cord. This proven to be extremely difficult. Recently, Food Drug Administration (FDA) released guidance on physiologic closed loop controlled (PCLC) devices, highlighting potential these therapies deliver accurate, real-time therapy, enhancing medical care reducing variability. Because growing neuromodulation market focus PCLC strategies, American Society Pain Neuroscience (ASPN) sought develop safety efficacy, along with taxonomy surrounding systems (PCLCSs) an evidence-based best practice review. Methods: A librarian-assisted literature search was performed identify manuscripts relevant topic stimulation management pain. Initial utilizing MEDLINE, EMBASE, Cochrane database, BioMed Central, Web Science. Included encompassed meta-analyses, systematic reviews, randomized trials (RCTs), prospective or retrospective studies follow-up 12 months, limited English language. MESH terms utilized included "closed-loop", "physiologic controlled", "spinal stimulation", "closed feedback", "feedback "neuromodulation", "pain", "persistent pain", "neuropathic "chronic pain". The modified USPSTF evidence recommendation grading strategy previously again employed. Results: Four were identified review, 2 prospective, one retrospective, study at least 12-month follow-up. Conclusion: is innovation that requires responsible introduction. As commercial access grows, there responsibility consistency definition, generation, focused efficacy. Keywords: stimulation, clinical neuropathic pain,

Language: Английский

Citations

0
Demystifying Spinal Cord Stimulation as Not More Than a Placebo: An Evidence‐Based Perspective DOI
Marc Russo, Robert M. Levy, Luana Colloca

et al.

Pain Practice, Journal Year: 2025, Volume and Issue: 25(5)

Published: May 20, 2025

Language: Английский

Citations

0
Neurophysiological outcomes that sustained clinically significant improvements over 3 years of physiologic ECAP-controlled closed-loop spinal cord stimulation for the treatment of chronic pain DOI Creative Commons
Nagy Mekhail, Robert M. Levy, Timothy R. Deer

et al.

Regional Anesthesia & Pain Medicine, Journal Year: 2024, Volume and Issue: unknown, P. rapm - 105370

Published: March 15, 2024

Introduction A novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of neural dose and accuracy stimulation, not possible any other commercially available SCS systems. The report objective measurements is essential to increase transparency reproducibility therapy. Here, we cohort EVOKE double-blind randomized trial treated CL-SCS for 36 months evaluate ECAP that sustained durability clinical improvements. Methods 41 patients remained in their treatment allocation were followed up through months. Objective neurophysiological data, including measures activation, analyzed. Pain relief was assessed determining proportion ≥50% ≥80% reduction overall back leg pain. Results performance loop resulted high-dose keeping elicited within 4µV target set on across all timepoints. Percent time stimulating above threshold >98%, ≥19.3µV. Most obtained (83%) (59%) pain response observed rates between 3-month 36-month follow-up (p=0.083 p=0.405, respectively). Conclusion results suggest physiological adherence supra-ECAP therapy generates inhibition provided ECAP-controlled leads durable improvements intensity no evidence loss therapeutic effect follow-up.

Language: Английский

Citations

3
Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy DOI Creative Commons
Jason E. Pope,

Ajay Antony,

Erika Petersen

et al.

Pain and Therapy, Journal Year: 2024, Volume and Issue: 13(5), P. 1173 - 1185

Published: July 9, 2024

Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation therapeutic neural activation pulse-to-pulse adjustment. We report on the immediate patient-reported neurophysiologic treatment response post-physiologic CL-SCS feasibility early responder prediction.

Language: Английский

Citations

3
Real-world evidence of durable multi-dimensional improvement after 60-day peripheral nerve stimulation treatment used for shoulder pain DOI Creative Commons

Ali Valimahomed,

David Dickerson,

Henry Vucetic

et al.

Pain Management, Journal Year: 2024, Volume and Issue: 14(7), P. 355 - 364

Published: July 2, 2024

This real-world analysis aims to quantify improvements in multiple health domains patients who received 60-day peripheral nerve stimulation (PNS) for shoulder pain.

Language: Английский

Citations

1
Validation of a holistic composite outcome measure for the evaluation of chronic pain interventions DOI Creative Commons
Rod S Taylor, Quinton Neville, Christopher M. Mullin

et al.

PAIN Reports, Journal Year: 2024, Volume and Issue: 9(6), P. e1202 - e1202

Published: Oct. 14, 2024

Abstract Introduction: Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using intensity measure alone to assess the effectiveness of chronic intervention fails fully evaluate its impact on multifaceted experience. The holistic minimal clinically important difference (MCID) composite outcome developed provide comprehensive assessment in response intervention, across 5 domains: intensity, health-related quality life, sleep quality, physical, and emotional function. To focus domains where individual need greatest, MCID reflects cumulative averaged over only subjects were impaired preintervention. Objectives: internal construct validity Holistic score inform future use as an evidence-based tool. Methods: This validation study was undertaken using data from EVOKE trial with 111 patients up 24-month follow-up. Internal consistency assessed Cronbach alpha statistic dimensional exploration principal component analysis. Results: demonstrated strong >0.7 at all follow-ups. Principal analysis showed one overarching dimension be present composite. Construct increase being associated both increased Patients' Global Impression Change, EuroQol visual analogue scale score, each “leave-one-out” (all P < 0.001). Conclusion: provides valid for comprehensive, personalized after intervention. requires further confirmation other populations different interventions.

Language: Английский

Citations

1