Analgesic Efficacy of “Burst” and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study

Sam Eldabe, Rui Duarte, Ashish Gulve, Heather Williams, Fay Garner, Morag Brookes, Grace Madzinga, Eric Buchser, Alan M. Batterham

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: The aim of this study was to compare the efficacy in reducing pain intensity in adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs. sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity. Materials and Methods: A multicentre randomized double-blind, three-period, three-treatment, crossover study was undertaken at two centers in the United Kingdom. Patients who had achieved stable pain relief with a conventional SCS capable of automated postural adjustment of current intensity were randomized to sequences of BST, T500, and sham SCS with treatment order balanced across the six possible sequences. A current leakage was programmed into the implantable pulse generator (IPG) in the sham period. The primary outcome was patient reported pain intensity using a visual analog scale (VAS). Results: Nineteen patients were enrolled and randomized. The mean reduction in pain with T500 was statistically significantly greater than that observed with either sham (25%; 95% CI, 8%–38%; p = 0.008) or BST (28%; 95% CI, 13%–41%; p = 0.002). There were no statistically significant differences in pain VAS for BST versus Sham (5%; 95% CI, −13% to 27%; p = 0.59). Exploratory sub-group analyses by study site and sex were also conducted for the T500 vs. sham and BST versus sham comparisons. Conclusions: The findings suggest a superior outcome versus sham from T500 stimulation over BST stimulation and a practical equivalence between BST and sham in a group of subjects with leg and back pain habituated to tonic SCS and having achieved a stable status with stimulation.

Original languageEnglish
Pages (from-to)471-478
Number of pages8
JournalNeuromodulation
Volume24
Issue number3
Early online date29 Nov 2020
DOIs
Publication statusPublished - 1 Apr 2021
Externally publishedYes

Bibliographical note

© 2020 International Neuromodulation Society.

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