Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction

• DOI: 10.1016/j.neurom.2024.01.006
• Publication Date: 2024-03-12T06:27:10Z
• Authors: Christopher Gilligan; Willem Volschenk; Marc Russo; Matthew Green; Christopher Gilmore; Vivek Mehta; Kristiaan Deckers; Kris De Smedt; Usman Latif; Dawood Sayed; Peter Georgius; Jonathan Gentile; Bruce Mitchell; Meredith Langhorst; Frank Huygen; Ganesan Baranidharan; Vikas Patel; Eugene Mironer; Edgar Ross; Alexios Carayanno...; Salim Hayek; Ashish Gulve; Jean-Pierre Van B...; Antoine Tohmeh; Jeffrey Fischgrund; Shivanand Lad; Farshad Ahadian; Timothy Deer; William Klemme; Richard Rauck; James Rathmell; Greg Maislin; Jan Pieter Heemels; Sam Eldabe
• Keywords: Male; Adult; Paraspinal Muscles; Electric Stimulation Therapy; Middle Aged; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Humans; Female; Longitudinal Studies; Prospective Studies; Chronic Pain; Low Back Pain; Follow-Up Studies; Pain Measurement; Aged

Adults with refractory, mechanical chronic low back pain associated with impaired neuromuscular control of the lumbar multifidus muscle have few treatment options that provide long-term clinical benefit. This study hypothesized that restorative neurostimulation, a rehabilitative treatment that activates the lumbar multifidus muscles to overcome underlying dysfunction, is safe and provides relevant and durable clinical benefit to patients with this specific etiology.In this prospective five-year longitudinal follow-up of the ReActiv8-B pivotal trial, participants (N = 204) had activity-limiting, moderate-to-severe, refractory, mechanical chronic low back pain, a positive prone instability test result indicating impaired multifidus muscle control, and no indications for spine surgery. Low back pain intensity (10-cm visual analog scale [VAS]), disability (Oswestry Disability Index), and quality of life (EuroQol's "EQ-5D-5L" index) were compared with baseline and following the intent-to-treat principle, with a supporting mixed-effects model for repeated measures that accounted for missing data.At five years (n = 126), low back pain VAS had improved from 7.3 to 2.4 cm (-4.9; 95% CI, -5.3 to -4.5 cm; p < 0.0001), and 71.8% of participants had a reduction of ≥50%. The Oswestry Disability Index improved from 39.1 to 16.5 (-22.7; 95% CI, -25.4 to -20.8; p < 0.0001), and 61.1% of participants had reduction of ≥20 points. The EQ-5D-5L index improved from 0.585 to 0.807 (0.231; 95% CI, 0.195-0.267; p < 0.0001). Although the mixed-effects model attenuated completed-case results, conclusions and statistical significance were maintained. Of 52 subjects who were on opioids at baseline and had a five-year visit, 46% discontinued, and 23% decreased intake. The safety profile compared favorably with neurostimulator treatments for other types of back pain. No lead migrations were observed.Over a five-year period, restorative neurostimulation provided clinically substantial and durable benefits with a favorable safety profile in patients with refractory chronic low back pain associated with multifidus muscle dysfunction.The Clinicaltrials.gov registration number for the study is NCT02577354; registration date: October 15, 2016; principal investigator: Christopher Gilligan, MD, Brigham and Women's Hospital, Boston, MA, USA. The study was conducted in Australia (Broadmeadow, New South Wales; Noosa Heads, Queensland; Welland, South Australia; Clayton, Victoria), Belgium (Sint-Niklaas; Wilrijk), The Netherlands (Rotterdam), UK (Leeds, London, Middlesbrough), and USA (La Jolla, CA; Santa Monica, CA; Aurora, CO; Carmel, IN; Indianapolis, IN; Kansas City, KS; Boston, MA; Royal Oak, MI; Durham, NC; Winston-Salem, NC; Cleveland, OH; Providence, RI; Spartanburg, SC; Spokane, WA; Charleston, WV).