Compelling Clinical Data

Collection of clinical evidence and scientific literature supporting Restorative Neurostimulation

Clinical Studies –
First ever randomized sham control research in neuromodulation

ReActiv8 – B Trial for FDA Approval

Summary

  • 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.

Summary

  • 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

Summary

  • 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

Summary

  • 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

Summary

  • 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

Restorative Neurostimulation –
Review literature and scientific discussions on the importance of this new therapy

Summary

  • 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.

Summary

  • 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.

Physiologic Testing –
How to objectively identify patients with neuromotor dysfunction

Summary

  • Observation of trunk movement is considered an important part of the clinical examination of patients with low back pain (LBP).
  • The presence of forward-bending movement aberrance is frequently seen in patients with acute/subacute, nonspecific LBP, compared to those without a history of LBP.
  • Aberrant movements indicate that some motor control or musculoskeletal impairment remains unresolved in this group.

Summary

  • The lumbar multifidus muscle is a critical contributor to lumbar spine stability and deficits in its function are associated with LBP. 
  • A physical examination method assessing multifidus function could provide great clinical utility as a diagnostic approach.
  • Results provide evidence supporting the reliability and validity of the Multifidus Lift Test (MLT) to assess lumbar multifidus function.

Summary

  • Clinical or functional instability consists of insufficient motor control and is a factor in abnormal inter-segmental movement and LBP, where no lumbar architecture defect can be observed on imaging. 
  • In the absence of imaging as a tool, reliable physical assessments are critical for proper diagnosis of functional instability. 
  • The prone instability test (PIT) demonstrates good reliability and moderate accuracy in diagnosing functional lumbar instability.

Role of the multifidus – how recent science has identified
this muscle as critical in preventing CLBP

Summary

  • The Multifidus morphology is uniquely different from other lumbar muscles, and therefore has a special role in lumbar stability.  
  • Changes in the multifidus have been found by many studies to be related to low back pain.
  • Injury and overloading of lumbar tissues has been shown to cause multifidus inhibition. 
  • Clinical studies have demonstrated that the multifidus can be rehabilitated and low back pain decreased.

Summary

  • Lumbar multifidus atrophy is related to low back pain.
  • Multifidus atrophy can be observed and categorized via MRI as fatty infiltration of the muscle. 
  • Multifidus fatty infiltration has been strongly associated with low back pain. 

Summary

  • The spinal stabilizing system consists of three subsystems: 
    • the passive spinal column subsystem, 
    • the active muscular subsystem,
    • the neural and feedback control subsystem. 
  • Injury, degeneration or disease can cause dysfunction in the spinal system, which cannot be compensated for beyond certain limits. 

Summary

  • The neutral zone is the spinal range of motion where there is little to no resistance. 
  • An increase in the size of the neutral zone is correlated with spinal degeneration and injury.
  • The bodies inability to maintain neutral zones within physiological limits, therefore causing mechanical dysfunction and pain, is termed “clinical instability”.  
  • Improved neurocontrol and motor function may reduce an aberrant neutral zone, decreasing clinical instability and reducing pain. 

Summary

  • Increased neutral zones as a result of injury or degeneration are shown to be correlated to pain. 
  • The spinal muscles provide significant stability to the spine.
  • Less efficient muscular control and decreased stability has been found in patients with low back pain. 
  • A compromised spinal system can be stabilized with muscle strengthening and retraining of the neuromuscular control system. 

Summary

  • Inhibition produces underlying weakness in muscles associated with joint disease, and studies suggest possible neurophysiological mechanisms are involved.
  • Severe motor inhibition limits the potential response to voluntary therapeutic exercise. 
  • Studies of intermittent neurostimulation of motor neurons in patients showed no evidence of the atrophy in type I and type II muscle fibers seen in untreated patients.