Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort

Simon Thomson, Rajiv Chawla, Sarah Love-Jones, Manohar Sharma, Girish Vajramani, Adam Williams, Sam Eldabe, ReActiv8 PMCF Investigators, Shaishav Bhagat, Nik Patel, Jane Hazelgrove, Simon Thomson, Rajiv Chawla, Sarah Love-Jones, Manohar Sharma, Girish Vajramani, Adam Williams, Sam Eldabe, ReActiv8 PMCF Investigators, Shaishav Bhagat, Nik Patel, Jane Hazelgrove

Abstract

Introduction: Low back pain impacts most people throughout the course of their lives and contributes significantly to the global burden of disease. In some patients, symptoms resolve with little intervention, while others are amenable to surgical intervention, some cases are intractable to current care paradigms. Restorative neurostimulation is an emerging therapy for chronic mechanical low back pain.

Methods: We conducted a prospective post-market follow-up of 42 patients treated for longstanding chronic mechanical low back pain with restorative neurostimulation. Patients were followed up at 45, 90, and 180 days and 1 and 2 years following activation of the device. Pain, disability, and health-related quality of life were recorded.

Results: Among the 37 patients completing 2-year follow-up, numerical rating scale (NRS) pain scores improved from 7.0 ± 0.2 to 3.5 ± 0.3 (p < 0.001), Oswestry Disability Index (ODI) scores improved from 46.2 ± 2.2 to 29.2 ± 3.1 (p < 0.001), and health-related quality of life (measured by the EuroQol 5-Dimension 5-Level questionnaire-EQ-5D-5L) improved from 0.426 ± 0.035 to 0.675 ± 0.030 (p < 0.001). Additionally, 57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements.

Conclusion: This real-world sample of patients shows that restorative neurostimulation can provide substantial and durable benefit to a cohort of patients that have traditionally had few reliable treatment options. Our findings support the continued used of this therapy in well-selected patients.

Trial registration: ClinicalTrials.gov Identifier: NCT01985230.

Keywords: Mechanical chronic low back pain; Multifidus; Real-world evidence; Restorative neurostimulation.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Implantation procedure and materials
Fig. 2
Fig. 2
Trial schema. Post-market clinical study of ReActiv8 therapy through 2 years. Patient follow-up will continue annually for up to 5 years
Fig. 3
Fig. 3
Patient disposition
Fig. 4
Fig. 4
Mean ± SEM patient-reported outcomes. a NRS, b ODI, c EQ-5D-5L showing statistically significant improvements over baseline at all time points (repeated-measures ANOVA with Bonferroni adjustment for multiplicity). Missing data were imputed using last observation carried forward
Fig. 5
Fig. 5
Proportion of patients reaching clinically meaningful thresholds in a pain NRS and b disability ODI
Fig. 6
Fig. 6
Waterfall plots demonstrating magnitude of effect and proportion of responders in a change in pain (NRS) and b change in disability (ODI) at 2 years over baseline

References

    1. Abbafati C, Abbas KM, Abbasi-Kangevari M, Abd-Allah F, Abdelalim A, Abdollahi M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396:1204–1222. doi: 10.1016/S0140-6736(20)30925-9.
    1. Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64:2028–2037. doi: 10.1002/art.34347.
    1. Hestbaek L, Leboeuf-Yde C, Manniche C. Low back pain: what is the long-term course? A review of studies of general patient populations. Eur Spine J. 2003;12:149–165. doi: 10.1007/s00586-002-0508-5.
    1. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8:8–20. doi: 10.1016/j.spinee.2007.10.005.
    1. Bridges S. Chapter 9: Chronic pain. Health survey for England—2011, health, social care and lifestyles. NHS Digital; 2012.
    1. Ferreira ML, Machado G, Latimer J, Maher C, Ferreira PH, Smeets RJ. Factors defining care-seeking in low back pain—a meta-analysis of population based surveys. Eur J. 2010;14:747.e1–747.e7.
    1. Spears CA, Hodges SE, Kiyani M, Yang Z, Edwards RM, Musick A, et al. Health care resource utilization and management of chronic, refractory low back pain in the United States. Spine. 2020;45:E1333–E1341. doi: 10.1097/BRS.0000000000003572.
    1. Bener A, Verjee M, Dafeeah EE, Falah O, Al-Juhaishi T, Schlogl J, et al. Psychological factors: anxiety, depression, and somatization symptoms in low back pain patients. J Pain Res. 2013;6:95–101. doi: 10.2147/JPR.S40740.
    1. Wynne-Jones G, Cowen J, Jordan JL, Uthman O, Main CJ, Glozier N, et al. Absence from work and return to work in people with back pain: a systematic review and meta-analysis. Occup Environ Med. 2014;71:448–458. doi: 10.1136/oemed-2013-101571.
    1. Kim LH, Vail D, Azad TD, Bentley JP, Zhang Y, Ho AL, et al. Expenditures and health care utilization among adults with newly diagnosed low back and lower extremity pain. JAMA Netw Open. 2019;2:e193676. doi: 10.1001/jamanetworkopen.2019.3676.
    1. Kamper SJ, Logan G, Copsey B, Thompson J, Machado GC, Abdel-Shaheed C, et al. What is usual care for low back pain? A systematic review of health care provided to patients with low back pain in family practice and emergency departments. Pain (US) 2020;161:694–702. doi: 10.1097/j.pain.0000000000001751.
    1. van Middelkoop M, Rubinstein SM, Verhagen AP, Ostelo RW, Koes BW, van Tulder MW. Exercise therapy for chronic nonspecific low-back pain. Best Pract Res Clin Rheumatol. 2010;24:193–204. doi: 10.1016/j.berh.2010.01.002.
    1. NICE . National Institute for Health and Care Excellence: Low back pain and sciatica in over 16s: assessment and management (NICE guideline 59) London: NICE; 2020.
    1. Russo M, Deckers K, Eldabe S, Kiesel K, Gilligan C, Vieceli J, et al. Muscle control and non-specific chronic low back pain. Neuromodulation. 2018;21:1–9. doi: 10.1111/ner.12738.
    1. Macedo LG, Latimer J, Maher CG, Hodges PW, McAuley JH, Nicholas MK, et al. Effect of motor control exercises versus graded activity in patients with chronic nonspecific low back pain: a randomized controlled trial. Phys Ther. 2012;92:363–377. doi: 10.2522/ptj.20110290.
    1. Smuck M, Crisostomo RA, Demirjian R, Fitch DS, Kennedy DJ, Geisser ME. Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study. Spine J. 2015;15:1415–1421. doi: 10.1016/j.spinee.2013.06.096.
    1. Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020;45:424–467. doi: 10.1136/rapm-2019-101243.
    1. Deckers K, De Smedt K, Mitchell B, Vivian D, Russo M, Georgius P, et al. New therapy for refractory chronic mechanical low back pain—restorative neurostimulation to activate the lumbar multifidus: one year results of a prospective multicenter clinical trial. Neuromodulation. 2018;21:48–55. doi: 10.1111/ner.12741.
    1. 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. (Article in press).
    1. Hicks GE, Fritz JM, Delitto A, Mishock J. Interrater reliability of clinical examination measures for identification of lumbar segmental instability. Arch Phys Med Rehabil. 2003;84:1858–1864. doi: 10.1016/S0003-9993(03)00365-4.
    1. Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005;44:227–239. doi: 10.1348/014466505X29657.
    1. Gilligan CJ, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, et al. Long-term outcomes of restorative neurostimulation in patients with refractory chronic low back pain secondary to multifidus dysfunction: 2-year results of the ReActiv8-B Pivotal Trial. Neuromodulation. 2021. (submitted).
    1. Eldabe S, Copley S, Gulve A, Baranidharan G, Bretherton B, Kansal A, et al. A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain. Pain. 2021. (Accepted for Publication).
    1. Kumar K, Taylor RS, Jacques L, Eldabe S, Meglio M, Molet J, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63:762–768. doi: 10.1227/01.NEU.0000325731.46702.D9.
    1. Gatchel R, Bevers K, Licciardone J, Su J, Du Y, Brotto M. Transitioning from acute to chronic pain: an examination of different trajectories of low-back pain. Healthcare. 2018;6:48. doi: 10.3390/healthcare6020048.
    1. Axén I, Leboeuf-Yde C. Trajectories of low back pain. Best Pract Res Clin Rheumatol. 2013;27:601–612. doi: 10.1016/j.berh.2013.10.004.
    1. Dunn KM, Campbell P, Jordan KP. Long-term trajectories of back pain: cohort study with 7-year follow-up. BMJ Open. 2013;3:1–7. doi: 10.1136/bmjopen-2013-003838.
    1. Kongsted A, Kent P, Axen I, Downie AS, Dunn KM. What have we learned from ten years of trajectory research in low back pain? BMC Musculoskelet Disord. 2016;17:220. doi: 10.1186/s12891-016-1071-2.

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