Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain-a Consecutive Cohort Study.

dc.contributor.author

Ardeshiri, Ardeshir

dc.contributor.author

Shaffrey, Christopher

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Stein, Klaus-Peter

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Sandalcioglu, Ibrahim Erol

dc.date.accessioned

2023-06-15T16:49:16Z

dc.date.available

2023-06-15T16:49:16Z

dc.date.issued

2022-09

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2023-06-15T16:49:16Z

dc.description.abstract

Background

Neuromuscular instability of the lumbar spine resulting from impaired motor control and degeneration of the multifidus muscle is a known root cause of refractory chronic low back pain (LBP). An implantable neurostimulation system that aims to restore multifidus motor control by stimulating the L2 medial branch of the dorsal ramus thereby relieving pain and reducing disability has demonstrated clinically significant benefits in the clinical trial setting. The 1-year results of a single-site real-world cohort study are presented.

Methods

This study recruited 44 consecutive patients with refractory, predominantly nociceptive axial chronic LBP, evidence of multifidus dysfunction, and no surgical indications or history of surgical intervention for chronic LBP. Each patient was implanted with a neurostimulation device. Pain (numeric rating scale), disability (Oswestry Disability Index), and quality of life (5-level EuroQol 5-Dimension) outcomes were collected at baseline and 3, 6, and 12 months after activation.

Results

Statistically significant improvements in pain, disability, and quality of life from baseline were seen at all assessment time points. At 12 months after activation, mean ± standard error of the mean numeric rating scale score was reduced from 7.6 ± 0.2 to 3.9 ± 0.4 (P < 0.001), Oswestry Disability Index score was reduced from 43.0 ± 2.8 to 25.8 ± 3.9 (P < 0.001), and 5-level EuroQol 5-Dimension index improved from 0.504 ± 0.034 to 0.755 ± 0.039 (P < 0.001). No lead migrations were observed. One patient required revision due to lead fracture.

Conclusions

Restorative neurostimulation is a new treatment option for well-selected patients with refractory chronic LBP. Clinically meaningful improvements in pain, disability, and quality of life demonstrated in routine clinical practice are consistent with published results of controlled trials.
dc.identifier

S1878-8750(22)01381-X

dc.identifier.issn

1878-8750

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1878-8769

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https://hdl.handle.net/10161/27989

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eng

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Elsevier BV

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World neurosurgery

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10.1016/j.wneu.2022.09.104

dc.subject

Chronic low back pain

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Dorsal ramus stimulation

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Lumbar multifidus

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Motor control

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Restorative neurostimulation

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Humans

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Low Back Pain

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Cohort Studies

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Quality of Life

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Lumbosacral Region

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Paraspinal Muscles

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Treatment Outcome

dc.title

Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain-a Consecutive Cohort Study.

dc.type

Journal article

duke.contributor.orcid

Shaffrey, Christopher|0000-0001-9760-8386

pubs.begin-page

S1878-8750(22)01381-X

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Duke

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School of Medicine

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Clinical Science Departments

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Orthopaedic Surgery

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Neurosurgery

pubs.publication-status

Published

pubs.volume

168

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