Treatment of failed back surgery syndrome patients with low back and leg pain: a pilot study of a new dual lead spinal cord stimulation system.

Objective. Treatment of pain associated with failed back surgery syndrome was evaluated in a pilot clinical study of a new dual lead spinal cord stimulation (SCS) system. Methods. The following data was retrospectively sought from 20 non-randomized patients at 2 centers treated by the new SCS system, instead of an implantable drug pump: 1) prior back surgeries, 2) pain and paresthesia mapping, 3) VAS ratings, 4) medication use, 5) sleep patterns, 6) physical abilities, 7) hardware problems, and 8) willingness to repeat the procedure. Two-year follow-up was sought from all patients. Results. The new dual lead SCS system provided good low back and leg paresthesia coverage. Patients reported having less pain and using fewer analgesics and narcotics during follow-up, compared to their preimplant experience. These improvements were statistically significant. Patients also improved their sleep and physical abilities during follow-up. While external hardware problems occurred, 65% of dual lead SCS patients were willing to repeat the SCS implant procedure. Conclusions. Dual lead stimulation proved beneficial for patients with low back and leg pain associated with failed back surgery syndrome.