Steven M. Falowski, MD: No relevant disclosure to display
Introduction: Chronic low back pain (CLBP) debilitating experiences are suffered by roughly 43 million in the United States (US) today. Unfortunately, patients with CLBP find inadequate symptom relief with conservative care. Restorative neurostimulation aims to treat pain and neuromuscular control impairments involving impaired multifidus dysfunction in patients with mechanical CLBP. This study aims to aggregate analyses across three clinical studies with a significant volume of published clinical data incorporating all pertinent demographics and outcomes from pre- and post-implantation of restorative neurostimulation.
Methods: Data from three restorative neurostimulation clinical trials (clinicaltrials.gov ID: NCT01985230, N=204, US, United Kingdom (UK), Europe, Australia, clinicaltrials.gov ID: NCT03255200, N=87, Germany, and clinicaltrial.gov ID: NCT01985230, N=42, UK7) were aggregated. All consented patients received an implanted restorative neurostimulation device for stimulation of the medial branches of the bilateral L2 dorsal rami. A cohort of 261 (78% of total) had complete assessments pre-operatively, and 6, 12, and 24 months post-operatively. Pain ratings (Numeric Pain Rating Scale (NPRS)/Visual Analog Scale (VAS)), disability (Oswestry Disability Index (ODI)), and quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L)) were collected. Inclusion and exclusion criteria were varied across studies, therefore, the minimum requirements for inclusion were identified.
Results: Patients (N=261; age=49.1±0.7yrs; F=51%; BMI=28.4±0.3kg/m2) at baseline rated ODI=40.6±0.8 and EQ-5D=0.544±0.013. At the 2-year follow-up, 65% reported >50% pain reduction, and 60% were classified as remitters (≤2.5 on VAS; ≤3 on NPRS) and 60% had >15-point reduction in ODI. Effects of demographics on outcomes were also assessed
Conclusion : Restorative neurostimulation is developing a significant evidence base to support safety, efficacy, and durability of this technique in mechanical CLBP patients with multifidus dysfunction.
