A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems

A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System

12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.

Inclusion Criteria:

1. Subject is appropriate for SCS implantation according to standard criteria
2. Subject is >18 to <75 years old
3. Subject is able and willing to comply with the follow-up schedule and protocol
4. Subject has chronic (> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
6. Subject is able to provide written informed consent

Exclusion Criteria:

1. Subject has no other exclusion criteria for SCS implantation according to standard criteria
2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
4. Subject has participated in another clinical study within 30 days
5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy