![]() ![]() Fifty-two patients did not meet inclusion criteria 159 patients were randomized 1:1 to either the CMM (n = 76) or 10-kHz SCS (n = 83) treatment group. The sample size was determined as previously described, 10 and 211 patients were enrolled in the study (for complete patient disposition, see Fig. ![]() For subset analyses, crossover patients were identified as “crossovers.” Patients in either treatment group were given the option to cross over to the other treatment arm at the 6-month visit if they met all the following criteria: < 50% back pain relief from baseline, documented dissatisfaction with the treatment, and investigator agreement. Patients were randomized 1:1 to one of two study treatment groups: 10-kHz SCS therapy plus CMM (referred to as 10-kHz SCS) or CMM alone. The protocol was amended to include an observational study extension to 24 months after baseline assessment or crossover, which required additional patient consent and is ongoing. Enrollment began in September 2018 and was completed in January 2020, with patients being followed for a 12-month period after baseline assessment. Appropriate interventional procedures were tried prior to enrollment in the study, and ongoing beneficial treatments were continued as needed.Ī total of 15 study centers in the US participated. These conservative measures could include medications, physical therapy, and interventional procedures such as radiofrequency ablation, steroid injections, and nerve blocks. The choice of appropriate CMM was made by the investigator to be the best standard of care for each individual patient. The system was programmed to high-frequency (10-kHz) electrical stimulation of the spinal cord via two implantable percutaneous leads and an implantable pulse generator (IPG). The Senza SCS system (Nevro Corp.) is an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with intractable low-back pain and leg pain, 16 with specific labeling for management of NSRBP. The “refractory” criterion means that all patients had undergone nonoperative treatment and did not achieve therapeutic goals prior to randomization. The primary inclusion criteria were having chronic, refractory back pain, not being an acceptable surgical candidate as assessed by a surgeon, and no previous spine surgery (complete listing in Supplementary Table 1). 10 Enrollment began in September 2018 for the multicenter, prospective, randomized study examining clinical efficacy, safety, and cost-effectiveness of 10-kHz SCS in addition to CMM versus CMM alone in subjects with NSRBP. The design of the NSRBP randomized controlled trial was previously reported by Patel et al. 12– 15 However, there are few analyses of prospectively collected healthcare utilization (HCU) data with 10-kHz SCS, and there has been no analysis specifically in the NSRBP population. Low-frequency and 10-kHz SCS have been found to significantly reduce costs when compared with CMM for chronic low-back pain, specifically in postsurgical low-back pain. With increasing healthcare costs, it is important to determine the cost benefit of treatments for chronic low-back pain. 10 The recently published 12-month results from a multicenter randomized controlled trial demonstrated improved outcomes for pain relief, function, and quality of life (QOL) with 10-kHz SCS therapy compared with CMM alone. 8, 9 Nonsurgical refractory back pain (NSRBP) refers to chronic neuropathic pain that is refractory to conventional medical management (CMM) among surgically naive patients who are not spine surgery candidates. 7 Most of the high-level evidence for SCS has supported treating chronic low-back pain that is postsurgical, 5 while limited evidence had supported SCS therapy for refractory back pain in patients who have not had previous spine surgery. The traditional stimulation parameters for SCS include frequencies between 30 and 120 Hz, but there is a growing body of evidence that high-frequency (10-kHz) SCS may produce greater pain reduction without the adverse side effect of paresthesia. 6 One such condition is chronic low-back pain. 4 Since its introduction in 1967, 5 SCS has gained widespread acceptance for the treatment of many chronic pain conditions. Spinal cord stimulation (SCS) is electrical stimulation of the spinal cord primarily used to provide relief of chronic pain. However, these treatments may have limited efficacy, without providing lasting relief. 2 Current nonsurgical treatments for chronic low-back pain include pharmacological treatments, physical therapy, and injections. 1 Patients with chronic low-back pain have more comorbidities and higher healthcare costs than those without. L ow- back pain is a leading cause of disability. ![]()
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