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Peripheral nerve stimulation (PNS) with micro-implantable pulse generator (IPG) presents as comfortable, easy to use option for the relief of chronic peripheral pain in over 80% of patients.
Findings from the study reported in “Regional Anesthesia and Pain Medicine” evaluated PNS along with micro-IPG for chronic peripheral pain treatment. Hatheway and co-authors conducted COMFORT, the first large-scale, post-market, multicentre, on-label, randomized control trial (RCT) documenting the effectiveness and safety of PNS and conventional medical management (CMM) versus CMM alone.
Randomization was performed in a 2:1 ratio, with subjects assigned to either the experimental group, which received PNS and CMM, or the control group, which received CMM only. Treatments were targeted to the shoulder, knee, lower back, foot and ankle.
The treatment group demonstrated 88% response rate, with an average pain reduction of 70%, indicating significant symptom improvement at 6 months. The active treatment group achieved a substantial lead over the control group at the 3-month primary endpoint, with an 84% responder rate and 67% average pain reduction, compared to 3% responder rate and 6% pain reduction in the control arm. The active arm displayed statistically significant responder rate and pain reduction, with a p-value of less than 0.001 in comparison to the control arm. No device-related cases like pocket pain or severe adverse events were reported. Comfort was a key aspect of the PNS system's design, with 81% of subjects stating that the external wearable component was comfortable.
Regional Anesthesia and Pain Medicine
Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial
John Hatheway et al.
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