(PS2) Two-year Outcomes from a Multicenter Randomized Controlled Trial Investigating the Effects of 10khz Spinal Cord Stimulation on Nonsurgical Refractory Back Pain

Introduction: Patients with moderate to severe chronic back pain, refractory to available non-operative therapies have limited options if they are not candidates for spine surgery. In addition, access to spinal cord stimulation (SCS) may be difficult due to previously limited clinical evidence for SCS in this patient population. Here, 24-month follow-up is reported from a RCT comparing 10kHz SCS versus conventional medical management (CMM) to treat non-surgical refractory back pain (NSRBP).

Methods: Patients were enrolled if they were ineligible for surgery based on surgical consultation, had moderate to severe refractory back pain, and had no previous spine surgery. Patients were randomized 1:1 to either 10kHz-SCS plus CMM or CMM alone. Both groups had the option of crossing over at 6 months. Also, patients could consent to a study extension to 24 months. We present pain relief reported on the VAS, Oswestry Disability Index (ODI), and quality-of-life (EQ-5D-5L) at 24 months(24M) for all implanted patients.

Results: Outcomes from 159 randomized patients at 3 and 6-months showed 10kHz SCS superior to CMM (p < 0.001) in terms of pain relief, disability, quality of life, and opioid reduction. At 6 months, none of the 69 patients in the 10kHz SCS arm chose to crossover, while 56/75 (74.7%) in the CMM arm crossed over, resulting in 125 implanted patients. Pain relief was maintained in implanted patients through 24M, with 81% reporting ≥50% pain relief at 24M. In addition, there was durable reduction in disability and improvement in quality-of-life at >2X the minimum clinically important difference. A total of 6/125 (4.8%) explants occurred during 24-month follow-up (infection(3), inefficacy(3)).

Conclusion : Profound and durable improvements in pain relief, function, and quality-of-life were obtained with the addition of 10kHz SCS to CMM in these NSRBP patients who have been deemed not surgical candidates and failed to achieve adequate pain relief with CMM.