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Randomized Controlled Trial
. 2020 Jan;23(1):109-117.
doi: 10.1111/ner.13019. Epub 2019 Jul 19.

Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period: Results From the Prospective, Multicenter, Randomized, DELIVERY Study

Jason E Pope  1 , Stefan Schu  2 , Dawood Sayed  3 , Ahmed M Raslan  4 , Ganesan Baranidharan  5 , Robert D Heros  6 , Bram Blomme  7 , Robyn A Capobianco  7 , Timothy R Deer  8
Affiliations
Randomized Controlled Trial

Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period: Results From the Prospective, Multicenter, Randomized, DELIVERY Study

Jason E Pope et al. Neuromodulation. 2020 Jan.

Abstract

Objective: The purpose of this study was to compare the trial success rate between anatomic lead placement (AP) and paresthesia-mapped (PM) lead placement techniques for spinal cord stimulation (SCS) using a nonlinear burst stimulation pattern.

Materials and methods: Eligible patients with back and/or leg pain with a Numeric Rating Scale (NRS) score of ≥6 who had not undergone previous SCS were enrolled in the study. A total of 270 patients were randomized in a 1:1 ratio to each treatment arm. In the AP group, one lead tip was placed at the mid-body of T8, and the other at the superior endplate of T9. In the PM group, physicians confirmed coverage of the patient's primary pain location. Trial success was a composite of the following: ≥50% patient-reported pain relief at the end of the minimum three-day trial period, physician's recommendation, and patient's interest in a permanent implant.

Results: Trial success for AP vs. PM groups was equivalent to 84.4% and 82.3%, respectively. Physicians who performed both techniques preferred AP technique (70% vs. 30%). Procedure times for placement of two leads were 31% shorter in the AP group (p < 0.0001). Decrease in the mean NRS pain score was similar between groups (53.2%, AP group; 53.8%, PM group, p = 0.79). Trial success for patients who went on to an extended trial with tonic stimulation was 50% (5/10) vs. 79% (11/14) for AP group and PM group, respectively (p = 0.2). A total of 13 adverse events were observed (4.5%), most commonly lead migrations and pain around implant site, with no difference between groups.

Conclusions: When using a nonlinear burst stimulation pattern, anatomic or PM lead placement technique may be used. Nonresponders to subthreshold stimulation had a higher conversion rate when a PM technique was used. AP resulted in shorter procedure times with a similar safety profile and was strongly preferred by trialing physicians.

Keywords: Burst stimulation therapy; chronic pain; intraoperative paresthesia testing; lead placement; spinal cord stimulation.

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Comment in

  • "Nonlinear" Burst Stimulation.
    North RB. North RB. Neuromodulation. 2020 Feb;23(2):260-261. doi: 10.1111/ner.13115. Neuromodulation. 2020. PMID: 32103591 No abstract available.

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