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An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.

Publication ,  Journal Article
Gilligan, C; Volschenk, W; Russo, M; Green, M; Gilmore, C; Mehta, V; Deckers, K; De Smedt, K; Latif, U; Georgius, P; Gentile, J; Mitchell, B ...
Published in: Pain
October 1, 2021

Chronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.gov identifier: NCT02577354). Two hundred four eligible participants with refractory mechanical (musculoskeletal) chronic LBP and a positive prone instability test indicating impaired multifidus control were implanted and randomized to therapeutic (N = 102) or low-level sham (N = 102) stimulation of the medial branch of the dorsal ramus nerve (multifidus nerve supply) for 30 minutes twice daily. The primary endpoint was the comparison of responder proportions (≥30% relief on the LBP visual analogue scale without analgesics increase) at 120 days. After the primary endpoint assessment, participants in the sham-control group switched to therapeutic stimulation and the combined cohort was assessed through 1 year for long-term outcomes and adverse events. The primary endpoint was inconclusive in terms of treatment superiority (57.1% vs 46.6%; difference: 10.4%; 95% confidence interval, -3.3% to 24.1%, P = 0.138). Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year. The incidence of serious procedure- or device-related adverse events (3.9%) compared favorably with other neuromodulation therapies for chronic pain.

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Published In

Pain

DOI

EISSN

1872-6623

Publication Date

October 1, 2021

Volume

162

Issue

10

Start / End Page

2486 / 2498

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pain Measurement
  • Lumbosacral Region
  • Low Back Pain
  • Humans
  • Double-Blind Method
  • Chronic Pain
  • Anesthesiology
  • 52 Psychology
  • 42 Health sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Gilligan, C., Volschenk, W., Russo, M., Green, M., Gilmore, C., Mehta, V., … ReActiv8-B investigators, . (2021). An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain, 162(10), 2486–2498. https://doi.org/10.1097/j.pain.0000000000002258
Gilligan, Christopher, Willem Volschenk, Marc Russo, Matthew Green, Christopher Gilmore, Vivek Mehta, Kristiaan Deckers, et al. “An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.Pain 162, no. 10 (October 1, 2021): 2486–98. https://doi.org/10.1097/j.pain.0000000000002258.
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, et al. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain. 2021 Oct 1;162(10):2486–98.
Gilligan, Christopher, et al. “An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial.Pain, vol. 162, no. 10, Oct. 2021, pp. 2486–98. Pubmed, doi:10.1097/j.pain.0000000000002258.
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten J-P, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Levy R, Heemels JP, Eldabe S, ReActiv8-B investigators. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain. 2021 Oct 1;162(10):2486–2498.

Published In

Pain

DOI

EISSN

1872-6623

Publication Date

October 1, 2021

Volume

162

Issue

10

Start / End Page

2486 / 2498

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Pain Measurement
  • Lumbosacral Region
  • Low Back Pain
  • Humans
  • Double-Blind Method
  • Chronic Pain
  • Anesthesiology
  • 52 Psychology
  • 42 Health sciences