Physician Argires Marotti Neurosurgical Associates of Lancaster Lancaster, PA, US
Introduction: Debilitation chronic low back pain (CLBP) experiences are suffered by roughly 43 million in the United States (US) today.1,2 Unfortunately, patients with CLBP find inadequate symptom relief with conservative care. Restorative neurostimulation goals are to treat pain and neuromuscular control impairments involving multifidus dysfunction in patients with mechanical CLBP (having no radicular symptoms or need for surgery). 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 clinical trials in the US, United Kingdom (UK), Europe, Australia were aggregated (N=204, Clinicaltrials.gov Identifier: NCT025773543–5, N=87, Clinicaltrials.gov Identifier: NCT03255200, Germany6, and N=42, Clinicaltrials.gov Identifier: NCT01985230, UK)7. All consented patients received restorative neurostimulation implantable devices. Inclusion and exclusion criteria varied across studies, therefore, minimum inclusion requirements were identified.
A cohort (N=261, 78% of total) had complete assessments pre-operatively, and at six, 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 evaluated.
Results: At baseline, patients (mean ± standard deviation: N=261; age=49.1±0.7yrs; F=51%; BMI=28.4±0.3kg/m2) ODI ratings were 40.6±0.8 and EQ-5D-5L were 0.544±0.013. At the 2-year follow-up, 65% reported greater than 50% pain reduction, and 60% were classified as remitters (less than or equal to 2.5 and 3 for VAS and NRS, respectively) and 60% had greater than 15-point reduction in ODI. By two years, 74% of patients reported 50% reduction in pain and/or a 15-point reduction in ODI and 51% of patients experienced both. 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.
