Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial

Eldabe, Sam; Nevitt, Sarah J; Griffiths, Sara; Gulve, Ashish; Thomson, Simon; Baranidharan, Ganesan; Houten, Rachel; Brookes, Morag; Kansal, Anu; Earle, Jenny; Bell, Jill A.; Taylor, Rod S; Duarte, Rui

doi:10.1227/neu.0000000000002165

Cited by 15 publications

(7 citation statements)

References 58 publications

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“…In their study of patients undergoing a screening trial followed by OL-SCS implant versus going directly to OL-SCS implant, Eldabe et al reported clinically important reductions in pain intensity and EQ-5D at 36 months for both groups. 25 A ≥50% reduction in pain was observed for 33% (21/66) of the patients at 36 months. In the Eldabe et al study, different types of OL-SCS were used; the mean change in pain intensity measured on a Numerical Rating Scale from baseline was −2.80 for paresthetic stimulation, −1.87 for high-frequency stimulation and −2.04 for burst stimulation.…”

Section: Discussionmentioning

confidence: 89%

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

Mekhail,

Levy,

Deer

et al. 2023

Reg Anesth Pain Med

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IntroductionThe evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is associated with better outcomes when compared with fixed-output, open-loop SCS (OL-SCS) 36 months following implant.MethodsThe EVOKE study was a multicenter, participant-blinded, investigator-blinded, and outcome assessor-blinded, randomized, controlled, parallel-arm clinical trial that compared ECAP-controlled CL-SCS with fixed-output OL-SCS. Participants with chronic, intractable back and leg pain refractory to conservative therapy were enrolled between January 2017 and February 2018, with follow-up through 36 months. The primary outcome was a reduction of at least 50% in overall back and leg pain. Holistic treatment response, a composite outcome including pain intensity, physical and emotional functioning, sleep, and health-related quality of life, and objective neural activation was also assessed.ResultsAt 36 months, more CL-SCS than OL-SCS participants reported ≥50% reduction (CL-SCS=77.6%, OL-SCS=49.3%; difference: 28.4%, 95% CI 12.8% to 43.9%, p<0.001) and ≥80% reduction (CL-SCS=49.3%, OL-SCS=31.3%; difference: 17.9, 95% CI 1.6% to 34.2%, p=0.032) in overall back and leg pain intensity. Clinically meaningful improvements from baseline were observed at 36 months in both CL-SCS and OL-SCS groups in all other patient-reported outcomes with greater levels of improvement with CL-SCS. A greater proportion of patients with CL-SCS were holistic treatment responders at 36-month follow-up (44.8% vs 28.4%), with a greater cumulative responder score for CL-SCS patients. Greater neural activation and accuracy were observed with CL-SCS. There were no differences between CL-SCS and OL-SCS groups in adverse events. No explants due to loss of efficacy were observed in the CL-SCS group.ConclusionThis long-term evaluation with objective measurement of SCS therapy demonstrated that ECAP-controlled CL-SCS resulted in sustained, durable pain relief and superior holistic treatment response through 36 months. Greater neural activation and increased accuracy of therapy delivery were observed with ECAP-controlled CL-SCS than OL-SCS.Trial registration numberNCT02924129.

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Section: Discussionmentioning

confidence: 89%

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

Mekhail,

Levy,

Deer

et al. 2023

Reg Anesth Pain Med

Self Cite

View full text Add to dashboard Cite

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“…20 More recently, others have advocated for no trial because there was no difference in numerical rating scale scores at 36 months between patients with and without a trial. 21 Reimbursement rates of trials and different economic models across the globe will likely play a role in the debate and ultimate decision. Of note, although most trials are percutaneous, in some cases where anatomy or previous surgery prevents percutaneous lead passage, a “buried” lead trial may be used.…”

Section: Resultsmentioning

confidence: 99%

“…22,23 Table 2 summarizes the evolution of trialing in SCS. [12][13][14][15][16][17][18][19][20][21][24][25][26] What is the Current Role of Neuromonitoring?…”

Section: Evolution Of Trial Usage In Scs Placementmentioning

confidence: 99%

The Evolution of Surgical Technique in Spinal Cord Stimulation: A Scoping Review

Bean,

Goon,

McClure

et al. 2023

Operative Neurosurgery

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Since the advent of spinal cord stimulation (SCS), its operative technique has consistently advanced. We performed a scoping review of the literature regarding SCS operative techniques to highlight key advancements. To review, summarize, and highlight key changes in SCS implantation techniques since their inception. The authors performed a MEDLINE search inclusive of articles from 1967 to June 2023 including human and modeling studies written in English examining the role of trialing, intraoperative neuromonitoring, and surgical adaptations. Using the Rayyan platform, two reviewers performed a blinded title screen. Of the 960 articles, 197 were included in the title screen, 107 were included in the abstract review, and ultimately 69 articles met inclusion criteria. We examined the utility of trialing and found that historical controls showed significant efficacy, whereas recent results are more equivocal. We discuss the significant improvement in outcomes with intraoperative neuromonitoring for asleep SCS placement. We highlight technique improvements that led to significant reductions in infection, lead migration, and inadequate pain relief. Physicians implanting SCS systems for chronic pain management must continually refine their surgical techniques to keep up with this rapidly evolving therapy. In addition, through collaborative efforts of neuromodulators and industry, SCS is safer and more effective for patients suffering from chronic pain.

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“…The analysis in the current study of patients who completed the follow-up is consistent with other previous reports of SCS. [20][21][22][23][24]…”

Section: Original Researchmentioning

confidence: 99%

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

Mekhail,

Levy,

Deer

et al. 2024

Reg Anesth Pain Med

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IntroductionA 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 physiologic neural dose and the accuracy of the stimulation, not possible with any other commercially available SCS systems. The report of objective spinal cord measurements is essential to increase the transparency and reproducibility of SCS therapy. Here, we report a cohort of the EVOKE double-blind randomized controlled trial treated with CL-SCS for 36 months to evaluate the ECAP dose and accuracy that sustained the durability of clinical improvements.Methods41 patients randomized to CL-SCS remained in their treatment allocation and were followed up through 36 months. Objective neurophysiological data, including measures of spinal cord activation, were analyzed. Pain relief was assessed by determining the proportion of patients with ≥50% and ≥80% reduction in overall back and leg pain.ResultsThe performance of the feedback loop resulted in high-dose accuracy by keeping the elicited ECAP within 4µV of the target ECAP set on the system across all timepoints. Percent time stimulating above the ECAP threshold was >98%, and the ECAP dose was ≥19.3µV. Most patients obtained ≥50% reduction (83%) and ≥80% reduction (59%) in overall back and leg pain with a sustained response observed in the rates between 3-month and 36-month follow-up (p=0.083 and p=0.405, respectively).ConclusionThe results suggest that a physiological adherence to supra-ECAP threshold therapy that generates pain inhibition provided by ECAP-controlled CL-SCS leads to durable improvements in pain intensity with no evidence of loss of therapeutic effect through 36-month follow-up.

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Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial

Cited by 15 publications

References 58 publications

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

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

The Evolution of Surgical Technique in Spinal Cord Stimulation: A Scoping Review

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

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