Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Apr;24(3):479-487.
doi: 10.1111/ner.13345. Epub 2020 Dec 22.

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  1   2 , Richard Feltbower  2 , Beatrice Bretherton  1   3 , Tracey Crowther  1 , Lynne Cooper  1 , Paulito Castino  1 , Helen Radford  1   4
Affiliations

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 et al. Neuromodulation. 2021 Apr.

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.

PubMed Disclaimer

References

REFERENCES

    1. Deer T, Slavin KV, Amirdelfan K et al. Success using Neuromodulation with BURST (SUNBURST) study: results from a prospective, randomized controlled trial using a novel Burst waveform. Neuromodulation 2018;21:56-66. https://doi.org/10.1111/ner.12698.
    1. Duarte RV, Thomson S. Trial versus no trial of spinal cord stimulation for chronic neuropathic pain: cost analysis in United Kingdom National Health Service. Neuromodulation 2019;22:208-214. https://doi.org/10.1111/ner.12898.
    1. Kapural L, Yu C, Doust MW et al. Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain. Anesthesiology 2015;123:851-860. https://doi.org/10.1097/ALN.0000000000000774.
    1. Tiede J, Brown L, Gekht G, Vallejo R, Yearwood T, Morgan D. Novel spinal cord stimulation parameters in patients with predominant Back pain. Neuromodulation 2013;16:370-375. https://doi.org/10.1111/ner.12032.
    1. Van Buyten J-P, Al-Kaisy A, Smet I, Palmisani S, Smith T. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation 2013;16:59-66. https://doi.org/10.1111/ner.12006.