139 Durable Pain Relief With 10 kHz Spinal Cord Stimulation for Patients With Refractory Back Pain Who are not Surgical Candidates. (April 2023) - Patel, Naresh P.
Abstract : INTRODUCTION: A large multicenter RCT was undertaken to provide high level evidence of the clinical effectiveness of 10kHz SCS over conventional medical management (CMM) for the treatment of nonsurgical refractory back pain (NSRBP), and the 12-month results were recently published (Kapural et al, 2022). METHODS: Patients were enrolled if ineligible for surgery based on surgical consultation. Subjects were randomized 1:1 to either 10kHz SCS in addition to CMM or CMM alone. Both groups had the option of crossing over at 6 months if satisfactory pain relief was not achieved. In addition, all subjects had the option of consenting to a study extension to 24-months. We present pain relief reported on the visual analog scale (VAS), Oswestry Disability Index (ODI), and quality-of-life (EQ-5D-5L) at 18 months. RESULTS: There were 159 patients randomized to either CMM alone (n = 75) or to 10kHz SCS in addition to CMM (n=83), with similar baseline characteristics. None of the 69 implanted patients in the 10 kHz SCS arm chose to crossover to CMM arm, while 74.7% (56/75) in the CMM arm crossed over, resulting in 125 total implanted patients. A total of 5/125 (4%) explants occurred during 18-month follow-up, two due to dissatisfaction with therapy and three to infection (two replaced). At 18 months the following outcomes were achieved: durable pain relief (mean 71%, 95%CI 66-76%), 74% of patients with clinically significant disability improvement with 40% moving from severe/moderate disability to minimal disability, and significant improvement in all dimensions of the EQ-5D-5L. CONCLUSIONS: This large, multicenter study demonstrates that the addition of 10kHz SCS to CMM results in profound and durable improvements in pain relief, function, and quality-of-life in these NSRBP patients who have been deemed not surgical candidates and exhausted all available appropriate nonoperative medical management.