This prospective 100 consecutive PNFS patient outcome study demonstrates that PNFS can be a safe and effective treatment option for, otherwise, intractable chronic pain conditions. PNFS has the potential to fundamentally change the way we think about pain management.

ObjectivesThe purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS).Materials and MethodsFifty‐three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10‐Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ≥2‐point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ‐5D).ResultsFor 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ≥MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ≥MCID improvement in ODI was 52%, 57%, and 60% while those with ≥MCID improvement in EQ‐5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach.ConclusionsElectrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.

The false-negative rate for medial branch blocks is likely to be lower than previously reported. The rate of inadvertent intravascular injection for thoracic medial branch blocks is 0.7%. Cervical and lumbar medial branch blocks are associated with an overall rate of 3.9% and 3.7%, respectively. Although these rates are lower than previously reported, the incidence of false-negative blocks still justifies the use of contrast to confirm nonvascular injection.

Objective. This study aims to evaluate the usefulness of peripheral nerve stimulation as a treatment option for patients with chronic low back pain. Materials and Methods. More than 12 months, we collected data on consecutive patients who had successful trials and were subsequently implanted with octrode percutaneous leads placed subcutaneously within the major area of pain. Eleven patients met diagnostic criteria for failed back surgery syndrome. A questionnaire assessed outcomes including: pain, analgesic use, and patient satisfaction. The response rate was 93% (13/14): average follow-up time was seven months. Results. There was a significant decrease in pain levels: an average reduction of 3.77 visual analog scale points. Eleven patients (85%) reported successful outcomes and an average pain reduction of 4.18 points but two reported a poor response. Pain relief was highly correlated with reduced analgesia and patient satisfaction. No complications were reported. Conclusion. This study demonstrates a treatment option that is safe, nonpharmacologic, reversible, and effective for patients with chronic low back pain that have exhausted other treatment options. KEY WORDS:Chronic pain, failed back surgery syndrome, low back pain, neuromodulation, neuropathic pain, peripheral nerve stimulation.