Learn More About ReActiv8
Collection of clinical evidence and scientific literature supporting ReActiv8 Restorative Neurostimulation
Clinical Application of ReActiv8 (Course 1)
Take a deeper dive into ReActiv8 and Restorative Neurostimulation
Fundamentals of ReActiv8 Resorative Neurostimulation
Prone Instability Test
Multifidus Lift Test
Reading an MRI
Latest Clinical Data Publications
ReActiv8 – B Trial for FDA Approval
- 77% of participants had ≥50% VAS reduction
- 67% reported CLBP resolution (VAS ≤ 2.5 cm)
- 63% had a reduction in ODI of ≥20 points
- Trajectory and durability of three year clinical benefits are consistent with restoration of neuromuscular control and muscle rehabilitation.
- 72% of participants had ≥50% pain relief
- 67% reported CLBP resolution (VAS ≤ 2.5 cm)
- 62% had a reduction in ODI of ≥20 points
- Two-year results show durable, statistically significant, and clinically substantial benefits in patients with severe, disabling CLBP and multifidus muscle dysfunction
ReActiv8 – A Trial for CE Mark
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Real World Evidence
- 57% of patients experienced a substantial improvement of ≥ 50% reduction in NRS pain score
- 51% of patients experienced a substantial improvement of ≥ 15-point reduction in ODI score
- Excellent safety profile compared to similarly implanted devices
- 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-5D-5L)
- Response to ReActiv8 is durable and the 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
Society Position Statements
ReActiv8 – B Trial for FDA Approval
- 77% of participants had ≥50% VAS reduction
- 67% reported CLBP resolution (VAS ≤ 2.5 cm)
- 63% had a reduction in ODI of ≥20 points
- Trajectory and durability of three year clinical benefits are consistent with restoration of neuromuscular control and muscle rehabilitation.
- 72% of participants had ≥50% pain relief
- 67% reported CLBP resolution (VAS ≤ 2.5 cm)
- 62% had a reduction in ODI of ≥20 points
- Two-year results show durable, statistically significant, and clinically substantial benefits in patients with severe, disabling CLBP and multifidus muscle dysfunction
ReActiv8 – B Trial for CE Mark
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Real World Evidence
- Re-establishing control of the multifidus muscle may not be feasible with physical therapy and exercise alone.
- Direct electrical stimulation of the multifidus may be a suitable alternative for motor dysfunction.
- A combination of history, imaging, and multiple provocative maneuvers has allowed for increased accuracy in diagnosis, leading to excellent outcomes.
- Clinical instability is related to chronic low back pain.
- Altered motor control and inhibition of the multifidus is a cause of clinical instability and CLBP.
- Back pain due to disrupted muscle control is associated with neuroplastic changes in the motor cortex, which can be reversed with elimination of back pain.
- A program of biofeedback guided motor control exercise of the multifidus can restore some disrupted motor control, but traditional physiotherapy may be very difficult in the context of inhibition.
Payer Wins
ReActiv8 – C Trial for FDA Approval
- 77% of participants had ≥50% VAS reduction
- 67% reported CLBP resolution (VAS ≤ 2.5 cm)
- 63% had a reduction in ODI of ≥20 points
- Trajectory and durability of three year clinical benefits are consistent with restoration of neuromuscular control and muscle rehabilitation.
- 72% of participants had ≥50% pain relief
- 67% reported CLBP resolution (VAS ≤ 2.5 cm)
- 62% had a reduction in ODI of ≥20 points
- Two-year results show durable, statistically significant, and clinically substantial benefits in patients with severe, disabling CLBP and multifidus muscle dysfunction
ReActiv8 – C Trial for CE Mark
- 73% of Completers showed improvement ≥2 points on NRS
- 76% of Completers showed improvement ≥10 points on ODI
- 97% of Completers were very satisfied with treatment
- In participants with disabling intractable CLBP who receive long-term restorative neurostimulation, treatment satisfaction and results remain durable through four years.
Real World Evidence
- Re-establishing control of the multifidus muscle may not be feasible with physical therapy and exercise alone.
- Direct electrical stimulation of the multifidus may be a suitable alternative for motor dysfunction.
- A combination of history, imaging, and multiple provocative maneuvers has allowed for increased accuracy in diagnosis, leading to excellent outcomes.
- Clinical instability is related to chronic low back pain.
- Altered motor control and inhibition of the multifidus is a cause of clinical instability and CLBP.
- Back pain due to disrupted muscle control is associated with neuroplastic changes in the motor cortex, which can be reversed with elimination of back pain.
- A program of biofeedback guided motor control exercise of the multifidus can restore some disrupted motor control, but traditional physiotherapy may be very difficult in the context of inhibition.
