Introduction: Spinal cord stimulation (SCS) effectively manages a range of painful etiologies, but little published evidence supports its use for axial low back pain (1, 2). Here we present preliminary outcomes of a prospective multi-institutional clinical trial designed to assess the therapeutic value of SCS in treating axial back pain associated with failed back surgery syndrome (FBSS).

Methods: Subjects with FBSS and a primary complaint of axial low back pain were implanted with an SCS system (Precision™, Advanced Bionics). All SCS trial and permanent implant procedures were conducted according to standard clinical practice. Pain scores, quality of life (QOL), and disability assessments were gathered at 3, 6, and 12 months after activation of the SCS system and compared to baseline measures. Additional assessments were made at 3.5 months after a 2-week period of no stimulation.

Results: A total of 259 subjects at 24 sites consented to participate (subjects were 50% female, 97% Caucasian, 54 ±14 years). Of 226 temporary trials, 172 (76%) were successful, and 159 subjects (70%) received permanent implants. Reported here are outcome data for all subjects through 3.5 months, and for those subjects who have completed 6 and 12 month evaluations. A subsequent report will include all 12 month data.

SCS significantly reduced axial low back pain, and when present, leg and foot pain, from baseline at all time points (ps<0.001). With stimulation off, pain scores returned to near baseline. QOL and disability also significantly improved with SCS.

Conclusions: This study represents the largest prospective experience reported to date for SCS in axial low back pain (2). Careful patient selection and stimulation programming can improve capture of the axial low back with SCS. Technological capabilities of the SCS system, particularly fractionalized current across contacts, uniquely provide the type of stimulation needed to relieve axial back pain.