Improved Pain Control with Combination Spinal Cord Stimulator Therapy Utilizing Sub-perception and Traditional Paresthesia Based Waveforms: A Pilot Study

 Chronic back and neck pain affects 20% of Americans. Spinal cord stimulation (SCS) is an effective therapy for otherwise refractory chronic pain. Traditional SCS relies on low-frequency stimulus in the 40 - 60 Hz range causing robust paresthesia in regions overlapping with painful dermatomes.

 This study aims to determine the effect of superimposing sub-perception stimulation in patients who previously had good long-term relief with paresthesia.

 This is a prospective observational trial examining patients who had previously been implanted with paresthesia based SCS for failed back surgery syndrome (FBSS) or complex regional pain syndrome (CRPS). These patients presented for implantable pulse generator (IPG) replacement based on battery depletion with an IPG capable of combined sub-perception and paresthesia based SCS therapy. Patients were assessed immediately following the exchange and four weeks later using a telephone survey. Their pain was assessed on each follow up using a Numerical Rating scale (NRS); the primary outcome was the change in NRS after four weeks from the exchange day. Secondary outcomes included paresthesia changes, which included the subjective quality of sensation generated, the overall subjective coverage of the painful region, subjective variation of coverage with positional changes, and global perception of the percentage improvement in pain.

 Based on our clinic registry, 30 patients were eligible for IPG exchange, 16 were consented for follow up and underwent an exchange, and 15 were available for follow up four weeks following. The average NRS decreased from 7.47 with traditional SCS to 4.5 with combination therapy. 80% of patients reported an improvement in the quality of paresthesia over traditional SCS therapy, and in most patients, this translated to significantly improved pain control.

 Our findings suggest improved pain relief in patients who had previously had good results with paresthesia based therapy and subsequently underwent IPG exchange to a device capable of delivering combined sub-perception stimulation. The mechanism of action is unclear though there may be an additive and/or synergistic effect of the two waveforms delivered. Larger studies with long-term follow-up are needed to elucidate the durability of pain relief and the precise mechanism by which combined subperception and paresthesia based SCS may improve overall patient outcomes.