Stimulation-naïve patients from five large pain centers in the Netherlands, experienced in neurostimulation, were approached to take part in the study. We hypothesized that SCS is effective in the treatment of unilateral neuropathic leg pain, and that a 1000 Hz strategy is equally as effective as a 30 Hz strategy in pain suppression. In order to evaluate if one of these stimulation strategies would be an equally effective and advantageous treatment for unilateral neuropathic leg pain in stimulation-naïve patients, we decided to perform a study comparing a 1000 Hz strategy (the maximum frequency available in this neurostimulation system) to a conventional SCS strategy (30 Hz). We therefore chose to perform a study in the most well accepted and clearly defined patient group for SCS, namely predominant (greater than 80%) unilateral neuropathic leg pain. Low back pain may therefore consist of a mechanical, nociceptive, and/or neuropathic component, of which only neuropathic pain responds to spinal cord stimulation. The pathophysiology of low back pain is complex and includes mechanical disorders, non-mechanical diseases, and organ diseases. Randomized controlled trials (RCTs) using both conventional and higher frequencies showed a difference in effect between back and leg pain, and between conventional and higher frequencies. These strategies utilize a higher electrical frequency than conventional SCS (up to 10 kHz). At the conception of this study, a number of alternative SCS strategies became available. Ĭonventional SCS stimulation (30–80 Hz) is a treatment option for patients with FBSS. Spinal cord stimulation (SCS) is well established in the treatment of the neuropathic pain components of FBSS. One specific group with chronic neuropathic pain is patients with failed back surgery syndrome (FBSS). The effectiveness of conservative medical management is limited and treatments such as neurostimulation are used. Chronic pain can be classified into six categories, including chronic neuropathic pain, according to the new International Classification of Diseases, version 11 (ICD-11). Both stimulation strategies led to a large, sustainable, clinically relevant pain suppression and improvement in quality of life.Ĭhronic pain is a widespread disease, of moderate to severe intensity, which occurs in approximately 19% of adult Europeans, seriously affecting the quality of their social and working lives. We conclude that our hypothesis regarding the effect of 1000 Hz and 30 Hz stimulation strategies on pain suppression was confirmed. Medtronic provided a grant for additional study costs. Fifty percent of patients had greater than 80% pain suppression ( p < 0.001).Īt study termination, all events were resolved no unanticipated events were reported. Secondary outcomes (22 patients): pain suppression and improved quality of life were sustained at 12 months both were statistically significant and clinically relevant. Ninety-two percent of patients in both periods experienced greater than 34% pain suppression (minimal clinically important difference, MCID). There was no period effect (delta 4 mm, p = 0.42, 95% CI ), allowing direct intrapatient comparison of the treatment effect (delta 1 mm, p = 0.92, 95% CI ). The primary outcome was analyzed in 26 patients. The main investigators were blinded to strategy allocation, patients were blinded to the outcome, a blinded assessor analyzed the primary outcome. Primary outcome was pain suppression (mean of VAS scores 4×/day) during the crossover period. After a 5-day washout, they crossed over, for another 9 days. Thirty-two patients (18–70 years, minimum leg pain 50 mm on 100 mm visual analog scale (VAS), minimal back pain) were randomized (1:1) to start 1000 Hz or 30 Hz neurostimulation for 9 days. We hypothesized that the pain suppressive effects of 1000 Hz and 30 Hz spinal cord stimulation (SCS) strategies are equally effective in patients with chronic, neuropathic, unilateral leg pain after back surgery. Multicenter, randomized, double-blinded crossover study.
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