Comparison of Paresthesia Mapping With Anatomic Placement in Burst Spinal Cord Stimulation: Long-Term Results of the Prospective, Multicenter, Randomized, Double-Blind, Crossover CRISP Study

Adnan Al-Kaisy*, Ganesan Baranidharan, Haggai Sharon, Stefano Palmisani, David Pang, Onita Will, Samuel Wesley, Tracey Crowther, Karl Ward, Paul Castino, Adil Raza, Yagna J. Pathak, Filippo Agnesi, Thomas Yearwood

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: Spinal cord stimulation (SCS) is an effective therapy for chronic intractable pain. Conventional SCS involves electrode placement based on intraoperative paresthesia mapping; however, newer paradigms like burst may allow for anatomic placement of leads. Here, for the first time, we report the one-year safety and efficacy of burst SCS delivered using a lead placed with conventional, paresthesia mapping, or anatomic placement approach in subjects with chronic low back pain (CLBP). Materials and Methods: Subjects with CLBP were implanted with two leads. The first lead was placed to cross the T8/T9 disc and active contacts for this lead were chosen through paresthesia mapping. The second lead was placed at the T9/T10 spinal anatomic landmark. Subjects initially underwent a four-week, double-blinded, crossover trial with a two-week testing period with burst SCS delivered through each lead in a random order. At the end of trial period, subjects expressed their preference for one of the two leads. Subsequently, subjects received burst SCS with the preferred lead and were followed up at 3, 6, and 12 months. Pain intensity (visual analog scale), quality-of-life (EuroQol-5D instrument), and disability (Oswestry Disability Index) were evaluated at baseline and follow-up. Results: Forty-three subjects successfully completed the trial. Twenty-one preferred the paresthesia mapping lead and 21 preferred the anatomic placement lead. Anatomic placement lead was activated in one subject who had no preference. The pain scores (for back and leg) significantly improved from baseline for both lead placement groups at all follow-up time points, with no significant between-group differences. Conclusions: This study demonstrated that equivalent clinical benefits could be achieved with burst SCS using either paresthesia mapping or anatomic landmark-based approaches for lead placement. Nonparesthesia-based approaches, such as anatomic landmark-based lead placement investigated here, have the potential to simplify implantation of SCS and improve current surgical practice.

Original languageEnglish
Pages (from-to)85-93
Number of pages9
JournalNeuromodulation
Volume25
Issue number1
DOIs
StatePublished - Jan 2022

Funding

FundersFunder number
Mainstay Medical
Micron Device LLC
Abbott Laboratories
Medtronic
Boston Scientific Corporation
Saluda Medical
Nevro

    Keywords

    • Burst
    • burst spinal cord stimulation
    • failed back surgery syndrome
    • implant techniques
    • neuropathic pain

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