Application of restorative neurostimulation for chronic mechanical low back pain in an older population with 2-year follow up

Introduction Data on the Medicare-aged population show that older patients are major consumers of low back pain (LBP) interventions. An effective approach for patients with mechanical LBP that has been refractory to conservative management is restorative neurostimulation. The efficacy of restorative neurostimulation has been demonstrated in multiple prospective studies, with published follow-up over 4 years, showing a consistent durable effect.Methods To further examine the effect of restorative neurostimulation in an older demographic, data from three clinical studies were aggregated: ReActiv8-B prospectively followed 204 patients, ReActiv8-C study prospectively followed 87 patients and ReActiv8-PMCF prospectively followed 42 patients. Two hundred and sixty-one patients were identified with complete 2-year follow-up and divided into cohorts of equal size based of age quartiles. At 2 years from device activation, patients in either cohort were classified by change in disability (Oswestry Disability Index (ODI)) or change in pain score(NRS/VAS) and assessed as proportion of patients per group at each time point. Additionally, health-related quality of life (HRQoL) (EQ5D-5L) was longitudinally compared with baseline. Differences in proportions were assessed using chi 2 and continuous variables by repeated measures analysis of variance.Methods To further examine the effect of restorative neurostimulation in an older demographic, data from three clinical studies were aggregated: ReActiv8-B prospectively followed 204 patients, ReActiv8-C study prospectively followed 87 patients and ReActiv8-PMCF prospectively followed 42 patients. Two hundred and sixty-one patients were identified with complete 2-year follow-up and divided into cohorts of equal size based of age quartiles. At 2 years from device activation, patients in either cohort were classified by change in disability (Oswestry Disability Index (ODI)) or change in pain score(NRS/VAS) and assessed as proportion of patients per group at each time point. Additionally, health-related quality of life (HRQoL) (EQ5D-5L) was longitudinally compared with baseline. Differences in proportions were assessed using chi 2 and continuous variables by repeated measures analysis of variance.Methods To further examine the effect of restorative neurostimulation in an older demographic, data from three clinical studies were aggregated: ReActiv8-B prospectively followed 204 patients, ReActiv8-C study prospectively followed 87 patients and ReActiv8-PMCF prospectively followed 42 patients. Two hundred and sixty-one patients were identified with complete 2-year follow-up and divided into cohorts of equal size based of age quartiles. At 2 years from device activation, patients in either cohort were classified by change in disability (Oswestry Disability Index (ODI)) or change in pain score(NRS/VAS) and assessed as proportion of patients per group at each time point. Additionally, health-related quality of life (HRQoL) (EQ5D-5L) was longitudinally compared with baseline. Differences in proportions were assessed using chi 2 and continuous variables by repeated measures analysis of variance.Results The oldest quartile (n=65) had a median age of 60 (56-82) years compared with the entire population (n=261) who had a median age of 49 (22-82) years. The completer analysis on patients with 2 years of continuous data showed improvement of a 50% in pain was achieved by 62% and 65% and a 15-point ODI improvement in 48% and 60% in the oldest quartile and entire population, respectively. HRQoL (EuroQol 5-Dimension) improved from baselines of 0.568 and 0.544 to 0.763 and 0.769 in the oldest quartile and entire population respectively. All age quartiles improved statistically and clinically over baseline.Conclusions This aggregate analysis of three independent studies provides insight into the performance of restorative neurostimulation in an older population. Patients derived significant and clinically meaningful benefit in disability, pain and HRQoL. When compared with a similarly indicated cohort of younger patients, there were no statistically or clinically significant differences.