Treatment of chronic axial back pain with 60‐day percutaneous medial branch PNS: Primary end point results from a prospective, multicenter study

Abstract

Background:The objective of this prospective, multicenter study is to characterize responses to percutaneous medial branch peripheral nerve stimulation (PNS) to determine if results from earlier, smaller single-center studies and reports were generalizable when performed at a larger number and wider variety of centers in patients recalcitrant to nonsurgical treatments. Materials & Methods:Participants with chronic axial low back pain (LBP) were implanted with percutaneous PNS leads targeting the lumbar medial branch nerves for up to 60 days, after which the leads were removed. Participants were followed long-term for 12 months after the 2-month PNS treatment. Data collection is complete for visits through end of treatment with PNS (primary end point) and 6 months after lead removal (8 months after start of treatment), with some participant follow-up visits thereafter in progress. Results: Clinically and statistically significant reductions in pain intensity, disability, and pain interference were reported by a majority of participants. Seventy-three percent of participants were successes for the primary end point, reporting clinically significant (≥30%) reductions in back pain intensity after the 2-month percutaneous PNS treatment (n = 54/74). Whereas prospective follow-up is ongoing, among those who had already completed the long-term follow-up visits (n = 51), reductions in pain intensity, disability, and pain interference were sustained in a majority of participants through 14 months after the start of treatment. Conclusion:Given the minimally invasive, nondestructive nature of percutaneous PNS and the significant benefits experienced by participants who were recalcitrant to nonsurgical treatments, percutaneous PNS may provide a promising first-line neurostimulation treatment option for patients with chronic axial back pain.

Evidence-Based Clinical Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Peripheral Nerve Stimulation in the Treatment of Chronic Pain

“…19 Moreover, recent studies have demonstrated the role of PNS in peripheral and central analgesic mechanisms by modulating the inflammatory pathways, autonomic nervous system, endogenous pain inhibition pathways, and cortical and subcortical areas. 20,21 The ASPN society formed an international multidisciplinary panel consisting of anesthesiologists, neurosurgeons, and pain medicine physicians who are experts in the field of PNS neuromodulation to create these consensus practice guidelines. To qualify for inclusion on the expert panel, each author was required to have experience with performing PNS trials and lead implantation, publications and ongoing research pertaining to PNS neuromodulation, and impact on the field of neuromodulation.…”

Non-Spinal Neuromodulation of the Lumbar Medial Branch Nerve for Chronic Axial Low Back Pain: A Narrative Review

“…Percutaneous PNS of the LMBN is a relatively new modality, and to date, there are 10 human, clinical studies focusing on nonspinal neuromodulation for chronic axial LBP (16)(17)(18)(19)(20)(21)(22)(23)(24)(25). Kapural et al (25) was the first to publish clinical data using the SPRINT device.…”

“…Low-frequency pulse train stimulation of the LMBN terminal branches activates both sensory afferents and muscle efferent fibers, producing proprioceptive signals in large diameter fibers that convergently directly activate sensory afferents engaging in the spinal cord gating mechanism. Data are limited but have demonstrated sustained results, even after cessation of 60-day temporary stimulation for patients with multifactorial chronic axial low back pain, including degenerative disc disease, lumbar spondylosis, lumbar facet arthropathy, discogneic pain, etc (17,(20)(21)(22)(23)25). The permanently implanted restorative LMBN PNS system, on the other hand, has a more regimented minimally invasive technique.…”

“…93% had clinically significant improvement in at least 1 category at all time points ( 17 ). The most recent and robust study of the 60-day percutaneous PNS technique comes from Gilmore et al ( 20 ). In this study, 74 patients across multiple centers were followed for 8 months, with longer follow up visits completed in 51 patients.…”

Peripheral Nerve Stimulation for Chronic Shoulder Pain Due to Rotator Cuff Pathology

“…17-20 Additionally, there is some growing evidence to support the use of PNS as a non-opioid therapy to assist in the treatment of chronic axial back pain as well as other neuropathic pain conditions. [20][21][22] Studies on the use of PNS for chronic pain conditions continue to demonstrate that peripheral nerve stimulation can lead to significant improvement in pain and…”