Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact.

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Date

2023-02

Authors

Shaffrey, Christopher
Gilligan, Christopher

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Abstract

Background

High-impact chronic low back pain (CLBP) correlates with high healthcare resource utilization. Therapies that can alter impact status may provide beneficial long-term economic benefits. An implantable restorative neurostimulation system (ReActiv8, Mainstay Medical) designed to over-ride multifidus inhibition to facilitate motor control restoration, thereby resolving mechanical low back pain symptoms, has shown significant durable clinical effects in moderately and severely impacted patients.

Objective

To examine changes in high-impact chronic low back pain in patients treated with restorative neurostimulation at 2 years.

Methods

ReActiv8-B is a prospective, international, multicenter trial to evaluate the safety and efficacy of restorative neurostimulation in patients with intractable CLBP and no prior surgery. For this longitudinal subanalysis, patients were stratified into low-, moderate-, and high-impact CLBP categories using the US Department of Health and Human Services definition comprising pain intensity, duration, and impact on work, self-care, and daily activities.

Results

Of 2-year completers (n = 146), 71% had high-impact CLBP at baseline and this proportion reduced to 10%, with 85% reporting no or low impact. This corresponds with measurements of HRQoL returning to near-population norms.

Conclusion

In addition to clinically meaningful improvements in pain and function with long-term durability, the overwhelming majority of patients transitioned from a high- to a no- or low-impact CLBP state. This is typically associated with significantly lower healthcare-utilization levels. The of recovery trajectory is consistent with a restorative mechanism of action and suggests that over the long term, the improvement in these health states will be maintained.

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Subjects

Humans, Low Back Pain, Prospective Studies, Chronic Pain, Quality of Life, Pain Measurement

Citation

Published Version (Please cite this version)

10.1227/neu.0000000000002305

Publication Info

Shaffrey, Christopher, and Christopher Gilligan (2023). Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact. Neurosurgery, 92(4). pp. 716–724. 10.1227/neu.0000000000002305 Retrieved from https://hdl.handle.net/10161/27955.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Shaffrey

Christopher Ignatius Shaffrey

Professor of Orthopaedic Surgery

I have more than 25 years of experience treating patients of all ages with spinal disorders. I have had an interest in the management of spinal disorders since starting my medical education. I performed residencies in both orthopaedic surgery and neurosurgery to gain a comprehensive understanding of the entire range of spinal disorders. My goal has been to find innovative ways to manage the range of spinal conditions, straightforward to complex. I have a focus on managing patients with complex spinal disorders. My patient evaluation and management philosophy is to provide engaged, compassionate care that focuses on providing the simplest and least aggressive treatment option for a particular condition. In many cases, non-operative treatment options exist to improve a patient’s symptoms. I have been actively engaged in clinical research to find the best ways to manage spinal disorders in order to achieve better results with fewer complications.


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