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. 2021 Dec;10(2):1451-1465.
doi: 10.1007/s40122-021-00307-3. Epub 2021 Sep 3.

Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort

Simon Thomson  1 , Rajiv Chawla  2 , Sarah Love-Jones  3 , Manohar Sharma  2 , Girish Vajramani  4 , Adam Williams  3 , Sam Eldabe  5 ; ReActiv8 PMCF Investigators
Collaborators, Affiliations

Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort

Simon Thomson et al. Pain Ther. 2021 Dec.

Abstract

Introduction: Low back pain impacts most people throughout the course of their lives and contributes significantly to the global burden of disease. In some patients, symptoms resolve with little intervention, while others are amenable to surgical intervention, some cases are intractable to current care paradigms. Restorative neurostimulation is an emerging therapy for chronic mechanical low back pain.

Methods: We conducted a prospective post-market follow-up of 42 patients treated for longstanding chronic mechanical low back pain with restorative neurostimulation. Patients were followed up at 45, 90, and 180 days and 1 and 2 years following activation of the device. Pain, disability, and health-related quality of life were recorded.

Results: Among the 37 patients completing 2-year follow-up, numerical rating scale (NRS) pain scores improved from 7.0 ± 0.2 to 3.5 ± 0.3 (p < 0.001), Oswestry Disability Index (ODI) scores improved from 46.2 ± 2.2 to 29.2 ± 3.1 (p < 0.001), and health-related quality of life (measured by the EuroQol 5-Dimension 5-Level questionnaire-EQ-5D-5L) improved from 0.426 ± 0.035 to 0.675 ± 0.030 (p < 0.001). Additionally, 57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements.

Conclusion: This real-world sample of patients shows that restorative neurostimulation can provide substantial and durable benefit to a cohort of patients that have traditionally had few reliable treatment options. Our findings support the continued used of this therapy in well-selected patients.

Trial registration: ClinicalTrials.gov Identifier: NCT01985230.

Keywords: Mechanical chronic low back pain; Multifidus; Real-world evidence; Restorative neurostimulation.

Plain language summary

The goal of this study was to examine the effectiveness of restorative neurostimulation for the treatment of patients with chronic mechanical low back pain. This technique has been studied in a clinical trial setting and been shown to be both safe and effective. This study reports on the real-world experience from five sites in the United Kingdom. Patients with a history of severe low back pain that lasted on average for more than 13 years were implanted with a nerve stimulation device that targets the nerves that control important spinal stabilising muscles. All of the patients were asked to perform two stimulation sessions per day for 30 min each. Over the next 2 years, patients reported substantial reductions in pain and disability and an improvement in health-related quality of life. The safety profile of the therapy was excellent when compared to similar minimally invasive therapies for different spine pathologies. In this difficult-to-treat patient population who have few remaining therapeutic options, restorative neurostimulation is a valuable tool in the clinician’s armamentarium.

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Figures

Fig. 1
Fig. 1
Implantation procedure and materials
Fig. 2
Fig. 2
Trial schema. Post-market clinical study of ReActiv8 therapy through 2 years. Patient follow-up will continue annually for up to 5 years
Fig. 3
Fig. 3
Patient disposition
Fig. 4
Fig. 4
Mean ± SEM patient-reported outcomes. a NRS, b ODI, c EQ-5D-5L showing statistically significant improvements over baseline at all time points (repeated-measures ANOVA with Bonferroni adjustment for multiplicity). Missing data were imputed using last observation carried forward
Fig. 5
Fig. 5
Proportion of patients reaching clinically meaningful thresholds in a pain NRS and b disability ODI
Fig. 6
Fig. 6
Waterfall plots demonstrating magnitude of effect and proportion of responders in a change in pain (NRS) and b change in disability (ODI) at 2 years over baseline
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