title: Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-Month Results From a Multicenter, Randomized, Controlled Pivotal Trial.
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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  IPG, implantable pulse generatorMCID, minimal clinically important differencePI, permanent implantODI, Oswestry Disability IndexSCS, spinal cord stimulationVAS, Visual Analog Scale.
authors: *Center for Clinical Research and Carolina's Pain Institute, Winston-Salem, North Carolina;‡Swedish Pain Center, Seattle, Washington;§The Pain Center of Arizona and HOPE Research Institute, Phoenix, Arizona;¶Clinical and Regulatory Affairs, Nevro Corp., Menlo Park, California;‖Millennium Pain Center, Bloomington, Illinois;#Advanced Pain Therapy, PLLC, Hattiesburg, Mississippi;**IPM Medical Group, Inc., Walnut Creek, California;‡‡Pain Consultants of Oregon, Eugene, Oregon;§§Comprehensive Pain & Rehabilitation, Pascagoula, Mississippi;¶¶Coastal Orthopedics and Pain Medicine, Bradenton, Florida.
authors: Leonardo
authors: L
authors: Kapural
authors: Cong
authors: C
authors: Yu
authors: Matthew W
authors: MW
authors: Doust
authors: Bradford E
authors: BE
authors: Gliner
authors: Ricardo
authors: R
authors: Vallejo
authors: B Todd
authors: BT
authors: Sitzman
authors: Kasra
authors: K
authors: Amirdelfan
authors: Donna M
authors: DM
authors: Morgan
authors: Thomas L
authors: TL
authors: Yearwood
authors: Richard
authors: R
authors: Bundschu
authors: Thomas
authors: T
authors: Yang
authors: Ramsin
authors: R
authors: Benyamin
authors: Abram H
authors: AH
authors: Burgher
mesh_terms: D000328:Adult; D000368:Aged; D001416:Back Pain / Q000209:etiology / Q000628:therapy; D059350:Chronic Pain / Q000209:etiology / Q000628:therapy*; D055111:Failed Back Surgery Syndrome / Q000628:therapy*; D005260:Female; D006801:Humans; D055959:Intervertebral Disc Degeneration / Q000150:complications; D007866:Leg; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D010292:Paresthesia / Q000209:etiology; D011843:Radiculopathy / Q000209:etiology / Q000628:therapy*; D062187:Spinal Cord Stimulation / Q000379:methods*; D064232:Visual Analog Scale