INTRODUCTION: Chronic refractory back pain causes significant disability and is one of the most common reasons for patients seeking health care. Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for spine surgery, a condition we refer to as non-surgical refractory back pain (NSRBP). METHODS: Patients with NSRBP were evaluated after 1:1 randomization to 10kHz SCS plus CMM or CMM alone. Primary endpoint and secondary endpoints were assessed, and optional crossover was allowed at 6 months, with observational follow-up over 12 months (Kapural, 2022). All patients treated with 10kHz SCS were eligible for follow-up through 24 months after implantation. Outcomes included pain, Oswestry Disability Index (ODI), quality-of-life (EQ-5D-5L), 3-item Pain Sleep Questionnaire (PSQ-3), opioid use, patient’s global impression of change (PGIC), and safety. RESULTS: Of the 125 patients who received a permanent implant, 121 completed 12-month follow-up, 101 reconsented for extended follow-up, and 98 completed 24-month follow-up. At 24 months after implantation 82% achieved =50% pain relief. All outcome measures improved by at least double the minimal clinically important difference. Ninety-percent of patients met at least one of the multidimensional outcomes. Of those who reported opioid use during the study, and 62% of decreased or stopped. Through 24 months, 3 of 125 (2.4%) devices were explanted due to patient dissatisfaction with SCS therapy. CONCLUSIONS: The addition of 10kHz SCS to CMM in patients with NSRBP offers profound improvements at 24 months in pain, function, quality-of-life, and reduced opioid use. This study provides much-needed evidence to inform current clinical practice for managing patients with NSRBP.

OBJECTIVE The objective of this study was to evaluate the 24-month durability of pain relief, function, quality of life, and safety outcomes for patients with nonsurgical refractory back pain (NSRBP) treated with high-frequency spinal cord stimulation (SCS) within a large, national, multicenter randomized controlled trial (RCT). METHODS Following the completion of an RCT comparing high-frequency SCS plus CMM with CMM alone for the treatment of NSRBP, patients gave additional consent for a follow-up extension to 24 months. Presented is the cohort analysis of all patients treated with high-frequency SCS following the optional crossover at 6 months. The outcomes assessed to 24 months included responder rate of ≥ 50% pain relief measured according to the visual analog scale [VAS]), disability (Oswestry Disability Index [ODI]), quality of life (EQ-5D 5-level [EQ-5D-5L]), opioid reduction. RESULTS Of the 125 patients who received a permanent implant, 121 completed the 12-month follow-up, 101 gave additional consent for extended follow-up, and 98 completed the 24-month follow-up. At 24 months after implantation, the mean back pain VAS score was reduced by 73% and the responder rate was 82%. ODI and EQ-5D-5L both improved by at least double the minimal clinically important difference for each measure. No unexpected adverse events were observed, and the rates of serious adverse events (3.4%) and device explantations (4.8%) were low. CONCLUSIONS The addition of high-frequency SCS to CMM in patients with NSRBP offers profound improvements at 24 months in pain, function, quality of life, and reduced opioid use. This study provides much-needed evidence to inform current clinical practice for managing patients with NSRBP.

Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for spine surgery, a condition we refer to as non-surgical refractory back pain (NSRBP). Access to spinal cord stimulation (SCS) is inconsistent for NSRBP due to limited clinical evidence.1 Twenty-four-month (24M) outcomes are reported from a RCT that compared 10kHz-SCS to CMM in the treatment of NSRBP.

Chronic refractory back pain causes significant disability and has a major negative impact on mental health. Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for spine surgery, a condition we refer to as non-surgical refractory back pain (NSRBP). Access to spinal cord stimulation (SCS) is inconsistent in this population due to limited clinical evidence.1 Twenty-four-month outcomes including a functional test is reported from a RCT that compared 10kHz SCS to CMM in the treatment of NSRBP.

Patients with moderate to severe chronic back pain, refractory to available nonsurgical therapies (medications, physical therapy, nerve blocks and radio frequency ablation) have limited options if they are not candidates for surgery. In addition, access to spinal cord stimulation (SCS) may be difficult due to limited clinical evidence for SCS in this patient population (1). Here, 24-month follow-up is reported from a RCT that was designed to compare clinical and cost-effectiveness of 10kHz SCS versus CMM to treat non-surgical refractory back pain (NSRBP).

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.

Previous studies have shown spinal cord stimulation (SCS) to be cost-effective in comparison to conventional medical management (CMM) in persistent back and leg pain following spine surgery (1), but this has not been studied in patients with chronic neuropathic and refractory back pain who do not respond to CMM and have no history of and are not good candidates for spine surgery, a condition we term non-surgical refractory back pain (NSRBP). This is the first randomized controlled study (RCT) to prospectively gather health care utilization (HCU) information in the NSRBP population.

Chronic refractory back pain has a major negative impact on mental health and quality of life (QOL), and a high societal cost in terms of lost productivity and health care utilization (HCU)1. Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for back surgery2, a condition we refer to as non-surgical refractory back pain (NSRBP). The objective of this multicenter, randomized controlled trial (RCT) is to produce evidence comparing 10kHz-SCS plus CMM (10kHz-SCS+CMM) to CMM alone for treatment of NSRBP in terms of clinical- and cost-effectiveness.

OBJECTIVE Spinal cord stimulation (SCS) at 10 kHz (10-kHz SCS) is a safe and effective therapy for treatment of chronic low-back pain. However, it is unclear from existing evidence whether these findings can be generalized to patients with chronic back pain that is refractory to conventional medical management (CMM) and who have no history of spine surgery and are not acceptable candidates for spine surgery. The authors have termed this condition "nonsurgical refractory back pain" (NSRBP) and conducted a multicenter, randomized controlled trial to compare CMM with and without 10-kHz SCS in this population. METHODS Patients with NSRBP, as defined above and with a spine surgeon consultation required for confirmation, were randomized 1:1 to patients undergoing CMM with and without 10-kHz SCS. CMM included nonsurgical treatment for back pain, according to physicians’ best practices and clinical guidelines. Primary and secondary endpoints included the responder rate (≥ 50% pain relief), disability (Oswestry Disability Index [ODI]), global impression of change, quality of life (EQ-5D-5L), and change in daily opioid use and were analyzed 3 and 6 months after randomization. The protocol allowed for an optional crossover at 6 months for both arms, with observational follow-up over 12 months. RESULTS In total, 159 patients were randomized; 76 received CMM, and 69 (83.1%) of the 83 patients who were assigned to the 10-kHz SCS group received a permanent implant. At the 3-month follow-up, 80.9% of patients who received stimulation and 1.3% of those who received CMM were found to be study responders (primary outcome, ≥ 50% pain relief; p < 0.001). There was also a significant difference between the treatment groups in all secondary outcomes at 6 months (p < 0.001). In the 10-kHz SCS arm, outcomes were sustained, including a mean 10-cm visual analog scale score of 2.1 ± 2.3 and 2.1 ± 2.2 and mean ODI score of 24.1 ± 16.1 and 24.0 ± 17.0 at 6 and 12 months, respectively (p = 0.9). In the CMM arm, 74.7% (56/75) of patients met the criteria for crossover and received an implant. The crossover arm obtained a 78.2% responder rate 6 months postimplantation. Five serious adverse events occurred (procedure-related, of 125 total permanent implants), all of which resolved without sequelae. CONCLUSIONS The study results, which included follow-up over 12 months, provide important insights into the durability of 10-kHz SCS therapy with respect to chronic refractory back pain, physical function, quality of life, and opioid use, informing the current clinical practice for pain management in patients with NSRBP.

There are few therapeutic options for patients with chronic refractory back pain who have had no prior spine surgery and are not acceptable candidates for spine surgery. In the large proportion of these patients who do not meet therapeutic goals with conventional medical management (CMM), 10 kHz SCS is a therapy that has shown promise in a feasibility study (1). But inconsistent health care payer reimbursement provides an impetus for providing stronger evidence for SCS treating this condition that we have termed "Non-Surgical Refractory Back Pain" (NSRBP). We present the 18-month extended follow-up from a randomized controlled trial (RCT) comparing 10kHz SCS to CMM in this population.

Background Spinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome. But many patients with chronic back pain have not had major back surgery or are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this condition nonsurgical refractory back pain (NSRBP). Level 1 evidence does not yet exist showing the therapeutic benefit of SCS for NSRBP. Objective To compare 10-kHz SCS plus CMM (10-kHz SCS + CMM) to CMM alone for treatment of NSRBP in terms of clinical and cost effectiveness. Study Design Multicenter, randomized controlled trial (RCT), with subjects randomized 1:1 to either 10-kHz SCS + CMM or CMM alone. Optional crossover occurs at 6 months if treatment does not achieve >= 50% pain relief. Methods Patients with NSRBP as defined above may be enrolled if they are ineligible for surgery based on surgical consultation. Subjects randomized to 10-kHz SCS + CMM will receive a permanent implant if sufficient pain relief is achieved in a temporary trial. Both groups will receive CMM per standard of care and will undergo assessments at baseline and at follow-ups to 12 months. Self-report outcomes include pain, disability, sleep, mental health, satisfaction, healthcare utilization, and quality of life. Results Enrollment was initiated on September 10, 2018. Prespecified independent interim analysis at 40% of the enrollment target indicated the sample size was sufficient to show superiority of treatment at the primary endpoint; therefore, enrollment was stopped at 211. Conclusions This large multicenter RCT will provide valuable evidence to guide clinical decisions in NSRBP.

Facial pain is often debilitating and can be characterized by a sharp, stabbing, burning, aching, and dysesthetic sensation. Specifically, trigeminal neuropathic pain (TNP), anesthesia dolorosa, and persistent idiopathic facial pain (PIFP) are difficult diseases to treat, can be quite debilitating and an effective, enduring treatment remains elusive.