title: Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial.
abstract: BACKGROUND
  Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain.
  
  
  METHODS
  A total of 198 subjects with both back and leg pain were randomized in a 1:1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit.
  
  
  RESULTS
  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 < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias.
  
  
  CONCLUSIONS
  HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.
authors.affiliation: From the Center for Clinical Research and Carolina's Pain Institute at Brookstown, Wake Forest Baptist Health, Winston-Salem, North Carolina (L.K.); Swedish Pain Center, Seattle, Washington (C.Y., T.Y.); The Pain Center of Arizona and HOPE Research Institute, Phoenix, Arizona (M.W.D.A.H.B.); Clinical and Regulatory Affairs, Nevro Corp., Menlo Park, California (B.E.G.); Millennium Pain Center, Bloomington, Illinois (R.V., R. Benyamin); Advanced Pain Therapy, PLLC, Hattiesburg, Mississippi (B.T.S.); IPM Medical Group, Inc., Walnut Creek, California (K.A.); Pain Consultants of Oregon, Eugene, Oregon (D.M.M.); Coastal Orthopedics and Pain Medicine, Bradenton, Florida (L.L.B., R. Bundschu); Comprehensive Pain and Rehabilitation, Pascagoula, Mississippi (T.L.Y.); and Houston Pain Associates, Houston, Texas (A.W.B.).
authors.forename: Leonardo
authors.initials: L
authors.lastname: Kapural
authors.forename: Cong
authors.initials: C
authors.lastname: Yu
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Doust
authors.forename: Bradford E
authors.initials: BE
authors.lastname: Gliner
authors.forename: Ricardo
authors.initials: R
authors.lastname: Vallejo
authors.forename: B Todd
authors.initials: BT
authors.lastname: Sitzman
authors.forename: Kasra
authors.initials: K
authors.lastname: Amirdelfan
authors.forename: Donna M
authors.initials: DM
authors.lastname: Morgan
authors.forename: Lora L
authors.initials: LL
authors.lastname: Brown
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Yearwood
authors.forename: Richard
authors.initials: R
authors.lastname: Bundschu
authors.forename: Allen W
authors.initials: AW
authors.lastname: Burton
authors.forename: Thomas
authors.initials: T
authors.lastname: Yang
authors.forename: Ramsin
authors.initials: R
authors.lastname: Benyamin
authors.forename: Abram H
authors.initials: AH
authors.lastname: Burgher
mesh_terms: D000328:Adult; D000368:Aged; D001416:Back Pain / Q000175:diagnosis / Q000628:therapy*; D059350:Chronic Pain / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007866:Leg / Q000473:pathology; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods / Q000592:standards; D011446:Prospective Studies; D062187:Spinal Cord Stimulation / Q000379:methods* / Q000592:standards*; D016896:Treatment Outcome