Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain

Abstract

BACKGROUND:Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10 therapy) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy.OBJECTIVE:To compare long-term results of HF10 therapy and traditional low-frequency SCS.METHODS:A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ≥5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ≥50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority.RESULTS:In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < .001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain: 76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P < .001 for non-inferiority and superiority; leg pain: 72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P < .001 for non-inferiority and P = .003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P < .001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P < .001 for non-inferiority and P = .002 for superiority).CONCLUSION:This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially.ABBREVIATIONS:IPG, implantable pulse generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog Scale

Long-term quality of life improvement for chronic intractable back and leg pain patients using spinal cord stimulation: 12-month results from the SENZA-RCT

“…This assessment is completed by both the patient (PGIC, A) and the clinician (CGIC, B). The total percentage of subjects whose change from baseline was classified as either "a great deal better" or "better" is indicated next to each bar Prior publications have demonstrated the safety, efficacy, and stability of 10 kHz SCS for long-term treatment of chronic, intractable pain of the trunk and limbs, including the axial low-back [23,29,49]. Results presented here further demonstrate that 10 kHz SCS markedly improves secondary outcomes that reflect the subjects' better health, functionality, and overall well-being.…”

“…Other study limitations include the subjects and the investigators not being masked to the assigned treatment group and the heterogeneity of pain diagnoses, as previously discussed [23].…”

“…But a combination of anatomical midline lead placement and stimulation parameters results in paresthesia-free pain relief with 10 kHz SCS. In a multicenter, randomized controlled trial (SENZA-RCT), 10 kHz SCS demonstrated superior, long-lasting back and leg pain relief, when compared to traditional, low-frequency SCS without the need for painparesthesia overlap [22,23]. At 12 months, the responder rates (≥ 50% pain relief) for the 10 kHz SCS and lowfrequency SCS were 76.5% and 49.3% for back pain and 72.9% and 49.3% for leg pain, respectively.…”

New Therapy for Refractory Chronic Mechanical Low Back Pain—Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

“…High frequency (10 kHz) SCS has demonstrated superiority compared to conventional SCS in patients with predominantly neuropathic pain 16. However, there is limited evidence of effectiveness in other patient populations.…”

Spinal cord stimulation for chronic non-cancer pain: a review of current evidence and practice

“…27 At 24-month follow-up, 76.5% and 72.9% of patients with HF-SCS had at least a 50% reduction in back pain and leg pain, respectively. 28 This reduction of pain was significantly higher than that for patients using tonic stimulation, where only 49.3% had at least a 50% reduction in back pain and leg pain. 28 Of note, HF-SCS also resulted in better outcomes in terms of disability and patient satisfaction, and one third of the patients had reduced opioid consumption.…”