Emerging Evidence for the Application of Restorative Neurostimulation in an Aging Population

Introduction: Low back pain is often referred to as a disease of the middle income and middle aged due to the emphasis of this condition on the impact to working-aged. Data from the Medicare population shows that eligible patients are still major consumers of low back pain interventions. In 2016 CMS reported over 2.4 million facet joint related procedures highlighting a significant burden of disease in this population.

An effective approach for patients with mechanical low back pain that has been refractory to conservative management is restorative neurostimulation (ReActiv8, Mainstay Medical, Dublin Ireland).

The efficacy of restorative neurostimulation has been demonstrated in a randomised controlled trial with 3 year published follow-up and several multi centre cohort studies with 2 and 4 year published data, showing a consistent durable effect.

Methods: The data from three clinical studies was aggregated. The ReActiv8 B study the ReActiv8-C study , and the ReActiv8-PMCF6 prospectively followed 204, 87 and 42 patients respectively in the US, UK Europe and Australia.

We identified two cohorts with completed cases at 2 years follow-up; an older aged population ≥ 60 (n=33), and a similarly sized young patient cohort ≤ 35 years old (n=28) and reported changes in disability, pain and quality of life.

Results: At 2 years, 20-point reductions in ODI were seen in 62% and 48% (p=0.4) of young and old patients respectively and 57% and 58%(p=1) of young and old patients had a remission of pain (VAS≤2.5 NRS≤3).

Conclusion : This aggregate analysis of three independent studies provides insight into the performance of restorative neurostimulation in a population over 60. Older patients derived significant and clinically meaningful benefit in disability, HRQoL and pain. When compared to a similarly indicated cohort of younger patients (≤35 years) there were no statistically or clinically significant differences.