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

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.

• Authors: Jason E Pope, Stefan Schu, Dawood Sayed, Ahmed M Raslan, Ganesan Baranidharan, Robert D Heros, Bram Blomme, Robyn A Capobianco, Timothy R Deer
• Journal: Neuromodulation : journal of the International Neuromodulation Society (Neuromodulation) Vol. 23 Issue 1 Pg. 109-117 (Jan 2020) ISSN: 1525-1403 [Electronic] United States
• PMID: 31323175 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2019 International Neuromodulation Society.

Topics

• Aged
• Chronic Pain (diagnosis, therapy)
• Double-Blind Method
• Female
• Forecasting
• Humans
• Implantable Neurostimulators
• Male
• Middle Aged
• Paresthesia
• Prospective Studies
• Spinal Cord Stimulation (instrumentation, methods)
• Treatment Outcome