Eldabe, Sam, Duarte, Rui, Gulve, Ashish, Williams, Heather, Garner, Fay, Brookes, Morag, Madzinga, Grace, Buchser, Eric and Batterham, Alan M
(2021)
Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.
NEUROMODULATION, 24 (3).
pp. 471-478.
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Abstract
<h4>Objectives</h4>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.<h4>Materials and methods</h4>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).<h4>Results</h4>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.<h4>Conclusions</h4>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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Burst stimulation, randomized double‐, blind crossover trial, sham stimulation, spinal cord stimulation, tonic sub‐, threshold stimulation |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 07 Dec 2020 08:55 |
| Last Modified: | 18 Jan 2023 23:19 |
| DOI: | 10.1111/ner.13321 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3109193 |
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