Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.
Burst stimulation
randomized double-blind crossover trial
sham stimulation
spinal cord stimulation
tonic sub-threshold stimulation
Journal
Neuromodulation : journal of the International Neuromodulation Society
ISSN: 1525-1403
Titre abrégé: Neuromodulation
Pays: United States
ID NLM: 9804159
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
revised:
29
10
2020
received:
20
09
2020
accepted:
31
10
2020
pubmed:
1
12
2020
medline:
19
8
2021
entrez:
30
11
2020
Statut:
ppublish
Résumé
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. 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). 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. 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.
Identifiants
pubmed: 33251662
doi: 10.1111/ner.13321
pii: S1094-7159(21)00053-2
doi:
Substances chimiques
Analgesics
0
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
471-478Subventions
Organisme : Medical Research Council
ID : MR/K02325X/1
Pays : United Kingdom
Organisme : Medtronic funded the study through a grant to South Tees Hospitals
Organisme : The study was sponsored by South Tees Hospitals. Medtronic played no further role in study design, execution, data analysis or write up.
Informations de copyright
© 2020 International Neuromodulation Society.
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