One-Year Results of Prospective Research Study Using 10 kHz Spinal Cord Stimulation in Persistent Nonoperated Low Back Pain of Neuropathic Origin: Maiden Back Study
Neuromodulation: Technology at the Neural Interface(2021)
Abstract
Purpose Spinal cord stimulation (SCS) is a recommended treatment for chronic neuropathic pain. Persistent nonoperative low back pain of neuropathic origin has profound negative impacts on patient's lives. This prospective, open label, research study aimed to explore the use of SCS in patients with associated features of central sensitisation such as allodynia and hyperalgesia. Materials and Methods Twenty-one patients with back pain and hyperalgesia or allodynia who had not had prior spinal surgery underwent a SCS trial followed by full implantation. SCS comprised administering electrical impulses epidurally at a frequency of 10 kHz and pulse width of 30 mu sec. Patients attended follow-up visits after 6 and 12 months of SCS. Repeated measure ANOVAs/Friedman tests explored change after 6 and 12 months of 10 kHz SCS. Independent sample t-tests/Mann-Whitney U tests examined differences in response after 12 months of 10 kHz SCS. Results Back and leg pain, quality of life (QoL), pain-related disability, and morphine equivalence significantly improved compared with baseline following 6 and 12 months of 10 kHz SCS. There were no increases in the consumption of opioids, amitriptyline, gabapentin or pregabalin in any patient. After 12 months of treatment, 52% encountered >= 50% improvement in back pain, 44% achieved remission (0-3 cm back pain VAS), 40% reported ODI scores between 0 and 40 and 60% experienced a reduction of at least 10 ODI points. Patients reporting >= 10-point improvement in ODI had significantly longer pain history durations and experienced significantly greater improvements in back pain, leg pain and QoL than those reporting <10-point improvement in ODI. Conclusion The 10 kHz SCS improved back and leg pain, QoL, pain-related disability and medication consumption in patients with nonoperative back pain of neuropathic origin. With further research incorporating a sham control arm, the efficacy of 10 kHz SCS in this patient cohort will become more established.
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Key words
10 ,kHz,Allodynia,Hyperalgesia,non‐,operative back pain,spinal cord stimulation
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