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

Ganesan Baranidharan; Richard Feltbower; Beatrice Bretherton; Tracey Crowther; Lynne Cooper; Paulito Castino; Helen Radford

doi:10.1111/ner.13345

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. 2021 Apr;24(3):479-487. doi: 10.1111/ner.13345. Epub 2020 Dec 22.

Authors

Ganesan Baranidharan^{1

2}, Richard Feltbower², Beatrice Bretherton^{1

3}, Tracey Crowther¹, Lynne Cooper¹, Paulito Castino¹, Helen Radford^{1

4}

Affiliations

¹ Leeds Teaching Hospitals NHS Trust, Leeds, UK.
² School of Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.
³ School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds, UK.
⁴ School of Medicine, Leeds Institute of Clinical Trials Research, Faculty of Medicine & Health, University of Leeds, Leeds, UK.

PMID: 33351230
DOI: 10.1111/ner.13345

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 μsec. 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.

Keywords: 10 kHz; Allodynia; Hyperalgesia; non-operative back pain; spinal cord stimulation.

MeSH terms

Chronic Pain* / therapy
Humans
Low Back Pain* / therapy
Prospective Studies
Quality of Life
Spinal Cord
Spinal Cord Stimulation*
Treatment Outcome