10 kHz Spinal Cord Stimulation for the Treatment of Failed Back Surgery Syndrome with Predominant Leg Pain: Results from a Prospective Study in Patients from the Dutch Healthcare System

Abstract

Introduction Persistent back/and or leg pain is a common outcome after spinal surgery (otherwise known as failed back surgery syndrome [FBSS]). Studies have shown that spinal cord stimulation (SCS) at 10 kHz provides effective analgesia in FBSS patients with both back and leg pain symptoms and in those with predominant back pain. This study is the first to evaluate the therapy in FBSS patients with predominant leg pain. Methods The safety and efficacy of 10 kHz SCS was evaluated in an uncontrolled, open‐label, prospective study of FBSS patients with predominant leg pain in the Netherlands. Follow‐ups were performed at 1, 3, 6, and 12 months post implantation. Results Sixty out of 68 patients (88%) experienced sufficient pain relief during a stimulation trial. Of these, 58 proceeded to permanent implantation of a 10 kHz SCS system. After 12 months of treatment, 80% of patients experienced ≥ 50% reduction in baseline leg pain, and a similar proportion (76%) experienced ≥ 50% reduction in baseline back pain. At least two‐thirds of patients were also leg pain and back pain remitters (visual analog scale [VAS] ≤ 2.5 cm). The therapy was also associated with a general improvement in patients’ quality of life, as measured by secondary outcomes including disability, perception of health improvement, mental well‐being, and satisfaction. A positive impact on opioid consumption was also observed. Conclusions Consistent with previous findings, 10 kHz SCS for the treatment of FBSS patients with predominant radicular symptoms is safe and effective and is associated with improved quality of life.

Physical functioning following spinal cord stimulation: a systematic review and meta-analysis

“…Figure 1 depicts the PRISMA flow chart of the study selection and inclusion process. A total of 36 studies met the inclusion criteria and were included for the qualitative analysis 22 40–74 Table 1. describes the characteristics of the included studies.…”

“…describes the characteristics of the included studies. There were 7 included RCTs,22 40 50 55 61 63 69 17 prospective studies,41–44 46 47 51 56 59 60 62 64 65 68 70–72 11 retrospective studies,45 48 49 52–54 57 58 66 67 73 and 1 ambispective observational study 74. Thirteen studies were conducted in multiple centers 41–43 46 51 55 56 61 63 68 69 72–74.…”

Application and future trends of spinal cord stimulation

“…Typical SCS indications such as FBSS or CRPS already enjoy a mature market. However, at the present stage, CMM is still the mainstream approach to treating neuropathic pain even though SCS has been available for decades and the performance of SCS therapy overwhelms some of the conventional ones [13]. Although it is not possible for SCS treatment to completely replace CMM due to the intrinsic drawbacks of SCS such as invasiveness and potential failures and complications, it is highly likely for SCS to replace some of the low-efficacy CMM treatments.…”

“…Kallewaard et.al found that HF-SCS took effect on nearly 90% of FBSS patients in their trial. Sixty patients received SCS implantation and after 12 months, 80% of them reported that their pain feeling had a reduction by more than 50% [13]. Nissen et.al analyzed more than 20 years of data collected from 224 patients implanted with SCS and focused on the comparison between CMM and SCS [14].…”

Management of Chronic and Neuropathic Pain with 10 kHz Spinal Cord Stimulation Technology: Summary of Findings from Preclinical and Clinical Studies

“…Second, a growing body of evidence demonstrates clinical superiority in favor of high-frequency 10 kHz SCS over LF-SCS [49][50][51][52][53]. There are numerous high-quality studies with evidence supporting the use of SCS in various conditions demonstrating superior pain relief and functional outcomes with spinal cord stimulation over comprehensive medical management, as well as opioid utilization reduction [54][55][56][57][58][59][60][61][62][63][64][65][66]. Clinical success with high-frequency 10 kHz SCS has been documented with numerous pivotal studies (Table 2).…”