Four-Year Durability of Restorative Neurostimulation Effectiveness in Patients with Chronic Low Back Pain
and Impaired Neuromuscular Control of Lumbar Spine Stability
Christopher Gilligan, MD* on behalf of the ReActive8-B study investigators, *Brigham and Women’s Hospital/Harvard Medical School, Boston, MA, USA
Background
•Mechanical chronic low back pain (CLBP) can result from impaired multifidus neuromuscular control
•Restorative neurostimulation facilitates overriding multifidus neuromuscular inhibition
•Restorative neurostimulation sham-controlled pivotal trial 4-year data shows long-term durability
Methods
•Clinicaltrials.gov ID = NCT025773541,2
•Inclusion criteria:
̶visual analog scale (VAS) ≥6 cm
̶Oswestry Disability Index (ODI) ≥21 points despite optimal medical management (OMM)
̶Prone Instability Test =positive for impaired motor control
̶No indicated surgery
1Gilligan, et al. Pain. (2021); 2Gilligan et al. Neuromodulation. (2021)
Baseline Demographics
•IRB consented participants implanted with restorative neurostimulation system (ReActiv8®, Mainstay Medical, Inc., Ireland)
•N=204, mean age (±SD) = 47(±9) years
•Mean VAS = 7.3±0.7 cm
•Mean ODI = 39±10
•EQ-5D-5L = 0.585±0.174 points
•97±8% pain-filled days in previous year
•37% on opioids
•52% failed interventional pain therapies
Results
•4-Year Data: N=115 with complete data
•73% of participants had a ≥50% VAS improve
•64% reported low back pain resolution (VAS≤2.5 cm)
•63% had a ≥20-point ODI improve
•Composite VAS and ODI scores: 79% had improvement of ≥50% in VAS cm and/or ≥20 ODI points
•76% using opioids at baseline showed reduced or discontinued consumption
•No lead migrations
•Explants due to inadequate relief = 26/204 (13%)
•Explants due to CLBP resolution = 12/204 (6%)
Discussion
•Restorative neurostimulation demonstrates effectiveness, durability, and safety after 4 years
•Imputed data accounted for attrition
•Effective minimally-invasive, reversible treatment for impaired multifidus neuromuscular control and refractory mechanical CLBP
4-year follow-up data analysis demonstrated restorative neurostimulation delivered significant:
•pain and disability reductions
•increased quality of life
•
Patients with refractory mechanical chronic low back pain (CLBP)
•reduced opioid consumption
•“definitely satisfied”
•Requested explant due to successful resolution of CLBP
One of the few neuromodulation trials with outcomes beyond 2 years
