How Should we Use Multicolumn Spinal Cord Stimulation to Optimize Back Pain Spatial Neural Targeting? A Prospective, Multicenter, Randomized, Double‐Blind, Controlled Trial ( ESTIMET Study)

2020 ◽  
Author(s):  
Philippe Rigoard ◽  
Maxime Billot ◽  
Pierre Ingrand ◽  
Isabelle Durand‐Zaleski ◽  
Manuel Roulaud ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Back Pain ◽  
Spinal Cord Stimulation ◽  
Controlled Trial ◽  
Double Blind

scholarly journals Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (MODULATE-LBP): A Trial Protocol

2019 ◽  
Author(s):  
Adnan Al-Kaisy ◽  
Jonathan Royds ◽  
Stefano Palmisani ◽  
David Pang ◽  
Samuel Wesley ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Low Back Pain ◽  
Back Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Controlled Trial ◽  
Low Back ◽  
Double Blind ◽  
Prior Surgery ◽  
Secondary Outcomes

Abstract Introduction Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. There is evidence demonstrating high frequency 10kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with Failed Back Surgery Syndrome (FBSS) but there is limited evidence in CNLBP without prior surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10kHz SCS for this population. Methods This is a multicentre double-blind randomised sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10kHz SCS plus usual care (intervention group) or sham 10kHz SCS plus usual care (control group) after full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. Primary outcome will be a 7 day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6-months adjusting for baseline outcome scores. Incremental cost per quality adjusted life year (QALY) will be calculated at 6-months and over the patient lifetime. Discussion The outcomes of this trial will inform clinical practice and healthcare policy on the role of high frequency 10kHz SCS for patients with CNLBP without prior surgery.

scholarly journals Multicentre, Double Blind, Randomised Sham-Controlled Trial of 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (MODULATE-LBP): A Trial Protocol

2019 ◽  
Author(s):  
Adnan Al-Kaisy ◽  
Jonathan Royds ◽  
Stefano Palmisani ◽  
David Pang ◽  
Samuel Wesley ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Low Back Pain ◽  
Back Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Controlled Trial ◽  
Low Back ◽  
Double Blind ◽  
Prior Surgery ◽  
Secondary Outcomes

Abstract Introduction Chronic neuropathic low back pain (CNLBP) is a debilitating condition in which established medical treatments seldom alleviate symptoms. There is evidence demonstrating high frequency 10kHz spinal cord stimulation (SCS) reduces pain and improves health-related quality of life in patients with Failed Back Surgery Syndrome (FBSS) but there is limited evidence in CNLBP without prior surgery. The aim of this multicentre randomised trial is to assess the clinical and cost-effectiveness of 10kHz SCS for this population. Methods This is a multicentre double-blind randomised sham-controlled trial with a parallel economic evaluation. A total of 96 patients with CNLBP who have not had spinal surgery will be implanted with an epidural lead and a sham lead outside the epidural space without a screening trial. Patients will be randomised 1:1 to 10kHz SCS plus usual care (intervention group) or sham 10kHz SCS plus usual care (control group) after full implant. The SCS devices will be programmed identically using a cathodal cascade. Participants will use their handheld programmer to alter the intensity of the stimulation as per routine practice. Primary outcome will be a 7 day daily pain diary. Secondary outcomes include the Oswestry Disability Index, complications, EQ-5D-5L, and health and social care costs. Outcomes will be assessed at baseline (pre-randomisation) and at 1 month, 3 months and 6 months after device activation. The primary analyses will compare primary and secondary outcomes between groups at 6-months adjusting for baseline outcome scores. Incremental cost per quality adjusted life year (QALY) will be calculated at 6-months and over the patient lifetime. Discussion The outcomes of this trial will inform clinical practice and healthcare policy on the role of high frequency 10kHz SCS for patients with CNLBP without prior surgery.

Randomized, Double-Blind Trial of Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Patients With Chronic Trunk and/or Limb Pain

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Steven M Falowski
Keyword(s):  
Spinal Cord ◽  
Back Pain ◽  
Spinal Cord Stimulation ◽  
Closed Loop ◽  
Open Loop ◽  
Therapeutic Window ◽  
Double Blind ◽  
Objective Evidence ◽  
Patient Reported ◽  
Compound Action

Abstract INTRODUCTION Spinal cord stimulation (SCS) is a well-established treatment for chronic pain. Advancements in SCS systems have focused on eliminating paresthesias, but long-term success rates remain suboptimal. Variability in spinal cord (SC) activation with open-loop systems results in unpredictable inhibition of pain processing pathways, and may limit the efficacy of SCS. We report the first randomized, double-blind, pivotal study of SCS and the first therapy to measure real-time in Vivo SC neurophysiology using evoked compound action potentials (ECAPs). This study provides comparative efficacy and safety of ECAP-controlled closed-loop (CL) feedback stimulation compared to open-loop (OL) stimulation, and objective evidence of the mechanism of action of SCS. METHODS A total of 134 subjects were randomized into OL or CL. Subjects and the clinical staff were blinded to the treatment assignment. Both groups received the same device. Programming was equivalent with the only difference being that the closed-loop feedback feature was enabled in the Investigational group. A pain assessment and other patient reported outcome measures per IMMPACT were collected. ECAPs were also collected in both groups to compare the magnitude of SC activation and the percentage of time within the therapeutic window. RESULTS The primary composite endpoint demonstrated superior results in overall pain responders (P = .005) for CL-SCS (82.3%) compared to OL-SCS (60.3%). In addition, all prespecified hierarchical endpoints demonstrated better outcomes in the CL group, with both back pain reduction (P = .015) and back pain responders (P = .003) demonstrating superiority. The magnitude of SC activation was 7 times greater for CL-SCS and CL subjects spend 50% more time within the therapeutic window. In both groups, subjects showed improvements across disability, psychological, sleep, quality of life, and satisfaction. CONCLUSION ECAP-controlled closed-loop SCS has demonstrated superior overall pain relief compared to open-loop SCS. The study has just completed the primary outcome data analysis.

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