Real-world two-year durability of restorative neurostimulation for treatment of multifidus dysfunction in patients with chronic low back pain: an observational German cohort study.

Abstract

To evaluate 2-year longitudinal patient-reported outcomes from a multisite, prospective observational study involving a real-world German cohort with mechanical chronic low back pain (CLBP) implanted with restorative neurostimulation. Patients with refractory, predominantly nociceptive, mechanical CLBP associated with lumbar multifidus dysfunction (N=87) consented to undergo restorative neurostimulation therapy implantation through five German clinics. Outcomes measures for pain (Numeric Pain Rating Scale), disability (Oswestry Disability Index-ODI), and quality of life (Euroqol's EQ-5D) were collected at 90 and 180 days, one year, and two years from therapy activation. The painDETECT scale assessed the likelihood of mixed pain presentation. Sub-cohorts of painDETECT scores ≥19 (High) and <19 (Low) were compared on outcomes to assess mixed pain response. Among patients with complete (n=74) and imputed data, all outcomes improved significantly at two years. Over 75% achieved pain reduction by ≥30%, 64% met the minimal clinically important difference for ODI, and EQ-5D improved by 0.233. High and Low painDETECT groups showed similar recovery patterns. No lead migrations nor unanticipated adverse device effects occurred over the two years. This two-year real-world analysis of German patients with CLBP due to multifidus dysfunction treated with restorative neurostimulation showed sustained improvements in pain and function. Patients with mixed pain responded similarly to those with predominantly nociceptive pain, though supplemental conservative strategies may be needed to optimize functional recovery.