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

dc.contributor.author

Shaffrey, Christopher

dc.contributor.author

Gilligan, Christopher

dc.date.accessioned

2023-06-15T14:44:37Z

dc.date.available

2023-06-15T14:44:37Z

dc.date.issued

2023-02

dc.date.updated

2023-06-15T14:44:37Z

dc.description.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.
dc.identifier

00006123-202304000-00008

dc.identifier.issn

0148-396X

dc.identifier.issn

1524-4040

dc.identifier.uri

https://hdl.handle.net/10161/27955

dc.language

eng

dc.publisher

Ovid Technologies (Wolters Kluwer Health)

dc.relation.ispartof

Neurosurgery

dc.relation.isversionof

10.1227/neu.0000000000002305

dc.subject

Humans

dc.subject

Low Back Pain

dc.subject

Prospective Studies

dc.subject

Chronic Pain

dc.subject

Quality of Life

dc.subject

Pain Measurement

dc.title

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

dc.type

Journal article

duke.contributor.orcid

Shaffrey, Christopher|0000-0001-9760-8386

pubs.begin-page

716

pubs.end-page

724

pubs.issue

4

pubs.organisational-group

Duke

pubs.organisational-group

School of Medicine

pubs.organisational-group

Clinical Science Departments

pubs.organisational-group

Orthopaedic Surgery

pubs.organisational-group

Neurosurgery

pubs.publication-status

Published

pubs.volume

92

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