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, Stefan Schu, Dawood Sayed, Ahmed Raslan, Ganesan Baranidharan, Robert D. Heros, Bram Blomme, Robyn A. Capobianco, Timothy R. Deer

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalNeuromodulation
DOIs
StatePublished - Jan 1 2019

Fingerprint

Paresthesia
Pain
Spinal Cord Stimulation
Physicians
Therapeutics
Lead
Leg
Arm
Safety

Keywords

  • Burst stimulation therapy
  • chronic pain
  • intraoperative paresthesia testing
  • lead placement
  • spinal cord stimulation

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

Cite this

Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period : Results From the Prospective, Multicenter, Randomized, DELIVERY Study. / Pope, Jason E.; Schu, Stefan; Sayed, Dawood; Raslan, Ahmed; Baranidharan, Ganesan; Heros, Robert D.; Blomme, Bram; Capobianco, Robyn A.; Deer, Timothy R.

In: Neuromodulation, 01.01.2019.

Research output: Contribution to journalArticle

Pope, Jason E. ; Schu, Stefan ; Sayed, Dawood ; Raslan, Ahmed ; Baranidharan, Ganesan ; Heros, Robert D. ; Blomme, Bram ; Capobianco, Robyn A. ; Deer, Timothy R. / Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period : Results From the Prospective, Multicenter, Randomized, DELIVERY Study. In: Neuromodulation. 2019.
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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.",
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AU - Pope, Jason E.

AU - Schu, Stefan

AU - Sayed, Dawood

AU - Raslan, Ahmed

AU - Baranidharan, Ganesan

AU - Heros, Robert D.

AU - Blomme, Bram

AU - Capobianco, Robyn A.

AU - Deer, Timothy R.

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N2 - 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.

AB - 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.

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KW - chronic pain

KW - intraoperative paresthesia testing

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