Compelling Clinical Data
Collection of clinical evidence and scientific literature supporting ReActiv8 Restorative Neurostimulation
Clinical Study Publications –
First ever randomized sham-controlled research in neuromodulation
ReActiv8-A Trial for CE Mark
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
- 3-year real-world data collected at 5 sites across the UK. 42 patients enrolled w/33 completing 3-year follow up.
- No formal inclusion or exclusion criteria enforced outside the IFU and indications of the CE Mark.
- 70% of patients reached the remitter threshold reporting mild to negligible pain (NRS ≤ 3) and 55% improved by more than 15 points on ODI.
- 75% of patients had a substantial or profound improvement in NRS (>50%) and/or ODI (>20 point). Patients reported a mean EQ-5D approaching an age matched UK population normal value.
- No lead migrations.
- Response to ReActiv8 consistent with the restorative mechanism of action and published pivotal trial data.
Restorative Neurostimulation –
Literature and scientific discussions on the importance of this new therapy
Physical Testing –
How to objectively identify patients with neuromotor dysfunction
- 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.
Role of the multifidus – how recent science has identified
this muscle as critical in preventing CLBP
- 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.
- 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.
- 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.
- 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.