PSPS ReActiv8 Position Statement
The Pacific Spine and Pain Society (PSPS) is dedicated to bridging the gap between spine surgery and pain medicine which often encounter the same patients. PSPS serves as an open forum to promote and criticize emerging technologies; it is rooted in research, clinical excellence, and patient-centric care. This includes advocacy and policy for access to care through our collaboration with other societies, the government, and third-party payers.
Patients with intractable axial or mechanical chronic low back pain are commonly seen by our disciplines. Many are refractory to physical therapy and medication, have no indications for surgery and may be chronic consumers of opioids. Their symptoms may be caused by impaired neuromuscular control of the multifidus muscles, which normally provide functional stability to the lumbar spine. This condition is specific, well understood and described in the literature, and diagnosable with simple functional tests. Because historically there were no effective and durable treatments for functional instability, we often resorted to palliative treatment of its symptoms with medication, injections, and rhizotomy and in some cases patients opted for lumbar fusion as a last resort.
Restorative neurostimulation targets the root cause of functional instability. Through bilateral stimulation of the L2 medial branch of the dorsal ramus nerve it (re)activates the multifidus muscles and afferent proprioception to facilitate restoration of neuromuscular control.
Several clinical studies, including the randomized, sham-controlled, double blinded pivotal trial, have consistently documented that this therapy is safe, fully reversible and provides substantial clinical benefits with up to 4-year durability evidence. Furthermore, published Real World Evidence is consistent with those of the RCT and other prospective studies.
Restorative neurostimulation addresses a real and important treatment gap we are facing and therefore exemplifies an ‘emerging technology, rooted in research, clinical excellence’ requiring our advocacy and policy for access to ‘patient-centric care’. Therefore, the PSPS Advocacy and Policy Committee is of the opinion that the current evidence base supports coverage of restorative neurostimulation for patients with intractable CLBP associated with multifidus dysfunction who are refractory to available conventional treatments and not indicated for spine surgery.
The members of PSPS urge commercial insurers and other third-party payers to take immediate steps towards creating a coverage policy that recognizes the unmet clinical need and the ample evidence in support of restorative neurostimulation in this very specific and severely affected patient group. This is an appropriate action that affords well indicated patients the opportunity to access this novel therapy while allowing appropriate governance of utilization. We are happy to contribute to any of the policy development work that might be required. Please don’t hesitate to reach out to us if we can be of assistance.
The Pacific Spine and Pain Society Advocacy and Policy Committee