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Research ArticleTesting & Regulatory Affairs

International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability

Morgan Lorio, Kai-Uwe Lewandrowski, Domagoj Coric, Frank Phillips and Christopher I. Shaffrey
International Journal of Spine Surgery August 2023, 8525; DOI: https://doi.org/10.14444/8525
Morgan Lorio
1 Advanced Orthopedics, Altamonte Springs, FL, USA
MD
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  • For correspondence: mloriomd@gmail.com
Kai-Uwe Lewandrowski
2 Center for Advanced Spine Care of Southern Arizona, The Surgical Institute of Tucson, Tucson, AZ, USA
3 Department of Orthopedics, Fundación Universitaria Sanitas, Bogotá, DC, Colombia
4 Department of Orthopedics Hospital Universitário Gaffre e Guinle, Universidade Federal do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil
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Domagoj Coric
5 Neuroscience Institute, Carolinas Healthcare System and Carolina Neurosurgery & Spine Associates, Charlotte, NC, USA
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Frank Phillips
6 Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL, USA
MD
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Christopher I. Shaffrey
7 Spine Division, Duke Neurosurgery, Duham, NC, USA
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  • Figure 1
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    Figure 1

    Panjabi’s model of spinal stability.9

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    Figure 2

    The US health care spending by payer for low back and neck pain totals $134.5 billion, compared with total diabetes spending of $111.2 billion and ischemic heart disease spending of $89.3 billion14 Reproduced with permission from Dieleman, J. L., et al., Journal of the American Medical Association, 2020, 323 (9) 863-884. Copyright © 2020. American Medical Association. All rights reserved.

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    Figure 3

    Motor control feedforward and feedback loops. Source: Adapted from Holm et al.74

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    Figure 4

    Key muscles of the lumbar trunk.

  • Figure 5
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    Figure 5

    Progression of acute to chronic low back pain. Source: Adapted from Hodges et al.7

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    Figure 6

    Anatomical orientation of the lumbar dorsal ramus.

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    Figure 7

    A restorative neurostimulation system.

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    Figure 8

    Implanted restorative neurostimulation system with lead fixation to the L2/3 intertransversarii.

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    Figure 9

    Anteroposterior and lateral view of the implanted leads. The leads are placed outside the spinal canal, adjacent to the peripheral nerve that innervates the multifidus muscle.

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    Figure 10

    Prone Instability Test. Source: Reprinted from Chakravarthy et al. Restorative neurostimulation: a clinical guide for therapy adoption. J Pain Res. 2022;15:1759–1774 under the Creative Commons Attribution Non-commercial license.

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    Figure 11

    Multifidus lift test. Source: Reprinted from Chakravarthy et al. Restorative neurostimulation: a clinical guide for therapy adoption. J Pain Res. 2022;15:1759–1774 under the Creative Commons Attribution Non-commercial license. The negative and positive responses have been reversed from the published version.

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    Figure 12

    Aberrant movement patterns/multifidus toe touch test.

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    Figure 13

    Magnetic resonance imaging classification of fatty infiltration. Source:Reprinted from Chakravarthy et al. Restorative neurostimulation: a clinical guide for therapy adoption. J Pain Res. 2022;15:1759–1774 under the Creative Commons Attribution Non-commercial license.

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    Figure 14

    Aggregated clinical data from published studies on restorative neurostimulation (ReActiv8-A Study,146,147 ReActiv8-B Study,150–153 ReActiv8-C Study,154 and ReActiv8-A-PMCF Study148,149).

Tables

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    Table 1

    Representative comparisons for behavioral therapies.

    Treatment Comparison and TimeframePainDepressionFunctional Status
    Cognitive behavioral therapy vs waiting list control
     Short term−0.6 (−0.97, –0.22)−1.92 (−6.16, 2.32)−0.37 (−0.87, 0.13)
    Behavioral treatment vs group exercise
     Short term−2.31 (−6.33, 1.7)0.25 (−0.07, 0.58)-
     Intermediate term1.18 (3.16, 5.53)0.02 (−0.32, 0.35)-
     Long term0.14 (−4.4, 4.67)0.07 (−0.27, 0.41)-
    • View popup
    Table 2

    Subjective factors for chronic low back resulting from clinical lumbar spine instability.

    Consultation Considerations
    Neuropathic origin
    • Does the pain present in a dermatomal pattern?

    • Is the pain unilateral leg pain?

    • Is the leg pain greater than the low back pain?

    • Are there sensory disturbances, such as allodynia or paresthesia?

    • Is there a lower limb motor disturbance?

    • Is there a positive Lasègue’s sign or straight leg raise?

    Mechanical origin
    • Does your back giving way or giving out cause feelings of instability?

    • Do you need to frequently crack or pop the back to reduce symptoms?

    • Do you experience painful catching or locking during trunk motions?

    • Do you experience pain during transitional activities (sit to stand, etc)?

    • Does returning to an erect position from flexion cause greater pain?

    • Do you find it more difficult to sit unsupported than with a backrest?

    • Do sudden, trivial, or mild movements such as brushing teeth or low load task while flexed cause pain?

    • Is pain worse with sustained postures (driving, extended standing, etc)?

    • Are you fearful of moving?

    • View popup
    Table 3

    Current published evidence for restorative neurostimulation for CLBP.

    Clinical StudyNumber of ParticipantsLOFEvidence LevelPublication
    Feasibility study263 moII-1Deckers et al 2015145
    ReActiv8-A5312 moII-1Deckers et al 2018146
    48 moII-1Mitchell et al 2021147
    ReActiv8- PMCF3724 moII-1Thomson et al 2021148
    36 moII-1Thomson et al 2023149
    ReActiv8-B204120 d/12 moI/IIGilligan et al 2021150
    24 moII-1Gilligan et al 2022151
    36 moII-1Gilligan et al 2022152
    48 moN/AGilligan et al153
    SubanalysisII-1Shaffrey et al 2022135
    ReActiv8-C4112 moII-1Ardeshiri et al 2022154
    • Abbreviation: LOF, length of follow-up.

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International Journal of Spine Surgery: 19 (S2)
International Journal of Spine Surgery
Vol. 19, Issue S2
1 Apr 2025
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International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability
Morgan Lorio, Kai-Uwe Lewandrowski, Domagoj Coric, Frank Phillips, Christopher I. Shaffrey
International Journal of Spine Surgery Aug 2023, 8525; DOI: 10.14444/8525

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International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability
Morgan Lorio, Kai-Uwe Lewandrowski, Domagoj Coric, Frank Phillips, Christopher I. Shaffrey
International Journal of Spine Surgery Aug 2023, 8525; DOI: 10.14444/8525
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  • Article
    • Abstract
    • MECHANICAL CHRONIC LOW BACK PAIN CLINICAL PRESENTATION
    • PREVALENCE
    • ROLE OF MUSCLES IN LBP
    • CURRENT TREATMENTS FOR CLBP
    • REVIEW OF RESTORATIVE NEUROSTIMULATION
    • PATIENT SELECTION CHARACTERISTICS
    • CLINICAL EVIDENCE SUMMARY
    • COMBINED OUTCOMES OF ReActiv8-A, ReActiv8-B, ReActiv8-C, AND ReActiv8-A-PMCF—1- TO 4-YEAR COMPLETERS
    • GUIDANCE ON APPROPRIATE COVERAGE CRITERIA
    • CURRENT COSTS ASSOCIATED WITH THE TREATMENT OF CLBP
    • CODING FOR RESTORATIVE NEUROSTIMULATION
    • CONCLUSION
    • LIMITATIONS
    • Footnotes
    • References
  • Figures & Data
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Keywords

  • low back pain
  • lumbar spine
  • restorative neurostimulation
  • peripheral nerve
  • multifidus

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