Data from 261 patients completing 2 year follow up from 3 clinical studies (ReActiv8-B, ReActiv8-C, and PMCF)
Combination of RCT data and Real World Evidence
Four equal sized cohorts analyzed based on age range (n=65)
Statistically significant improvements in disability (ODI) and quality of life (EQ-5D-5L) were seen at all assessment time points compared to baseline.
Consistent improvements in pain (VAS/NRS) at all time points compared to baseline.
Patients derived significant and clinically meaningful benefit in disability, health related quality of life, and pain, irrespective of age.
Two-year results show durable, statistically significant, and clinically substantial benefits in patients with severe, disabling CLBP and multifidus muscle dysfunction
Prospective, randomized, controlled multi-center study comparing the effectiveness of ReActiv8 to Optimal Medical Management (OMM) for the treatment of intractable chronic low back pain (CLBP)
25 sites randomized 226 patients: At one-year 94/99 (94.9%) of the treatment arm patients and 94/104 (90.3%) of the control arm were available for assessment of outcomes
ReActiv8 is superior to OMM for the treatment of mechanical chronic low back pain associated with multifidus muscle dysfunction
Clinically and statistically significant improvements in:
Disability (Oswestry Disability Index)
Low back pain (NRS)
Health-related Quality of Life (EQ-5D)
ReActiv8 patient improvements accumulate over time, consistent with the restorative mechanism of action
The majority of patients treated with OMM derived no benefit or had worsening disability, pain, and health-related quality of life at 1-year
ReActiv8 should be considered earlier in the care continuum for mechanical CLBP
Single surgeon, single center, real world evidence with one-year clinical follow-up
44 patients from the Reactiv8-C study were consecutively included into this cohort if they presented with back pain (NRS) ≥ 6 and no prior lumbar surgery
40 patients completed all required testing at the follow up visit showing statistically significant improvements in pain (NRS), disability (ODI) and quality of life (EQ-6D-5L)
Response to ReActiv8 is durable and benefits accumulate over time consistent with the restorative mechanism of action
No lead migrations
Results of this real-world experience are consistent with the published data from the earlier ReActiv8-A and ReActiv8-B studies
Full length presentation of “The Role Muscles in Chronic Low Back Pain: The relationship between multifidus dysfunction and restoration” and “5-Year Outcomes with Restorative Neurostimulation: Understanding the Mechanism of Action & Avoiding Palliative Treatments” with all presenters.
Society Support for ReActiv8 Restorative Neurostimulation
Summary
The highest-level trial of the permanently implanted PNS system was international, multi-center, prospective, randomized, active, sham controlled, blinded trial, which generated high, level I-A evidence supporting the significance of the treatment effect
The ReActiv8-B trial “demonstrated clinical effectiveness as measured by substantial and durable improvements in pain, disability, and quality of life in a cohort of patients with a favorable benefit risk profile
The rates of adverse events are consistent with known SAE rates for spinal cord stimulation therapy; however there was no finding of lead migration
The ASPN Back Group recommends offering the permanently implanted PNS system given that there is a high certainty that the net benefit is substantial
Summary
Restorative neurostimulation for CLBP is supported by several clinical studies that show robust and durable clinical effects over the pretreatment condition.
The totality of evidence suggests that in a well-selected patient population who have exhausted conventional care paradigms, the potential benefits outweigh the risks and costs.
These patients tend to be exposed to multiple therapies with limited durability, resulting in a continuous cycle of high-cost health care utilization.
Restorative neurostimulation should be considered for clinically appropriate patients who have exhausted reasonable conservative approaches.
Commercial Insurance Approval for ReActiv8 Restorative Neurostimulation
Take the First Step Towards ReActiv8 Restorative Neurostimulation for ReActiv8 Restorative Neurostimulation
