Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.
Neuromodulation
; 24(3): 471-478, 2021 Apr.
Article
en En
| MEDLINE
| ID: mdl-33251662
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 ANDMETHODS:
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.Palabras clave
Texto completo:
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Banco de datos:
MEDLINE
Asunto principal:
Dolor Crónico
/
Estimulación de la Médula Espinal
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Humans
Idioma:
En
Año:
2021
Tipo del documento:
Article