Burst Optimized Stimulation Study

This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms.

Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.

Inclusion criteria

• Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain;
• Subject has been exclusively using burst stimulation for at least three months;
• Subject is 18 years of age or older;
• Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation;
• Subject agrees not to add or increase pain-related medication from enrollment through the study duration;
• Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;

Exclusion criteria

• Subject is currently participating in a clinical investigation study that includes an active treatment arm;
• Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation;
• Subject has a non SJM neuromodulation device