Effect of Spinal Cord Burst Stimulation in Patients with Chronic Radicular Pain After Lumbar Surgery .
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Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial
JAMA . 2022 Oct 18;328(15):1506-1514.Fifty patients with chronic radicular pain after lumbar spinal surgery were included in this crossover randomized trial; they received 4 three-month periods of intervention: two 3 month periods of spinal cord burst stimulation, and two 3 month periods of placebo stimulation (stimulators were switched off). The closely-spaced, high-frequency stimulus was delivered through an implanted pulse generator connected to electrodes with leads. The primary outcome of interest was the change from baseline in the Oswestry Disability Index (ODI). Secondary outcomes of interest included leg and back pain, quality of life, physical activity levels, and adverse events. 91 stimulation periods and 89 placebo periods were included in the primary analysis. Results revealed no significant difference between burst stimulation and placebo on all primary and secondary outcomes. 9 adverse events occurred within 3 months of spinal cord stimulator implantation.
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