PMID- 37486284
OWN - NLM
STAT- MEDLINE
DCOM- 20231027
LR  - 20231027
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Linking)
VI  - 26
IP  - 7
DP  - 2023 Oct
TI  - A Novel, Paresthesia-Free Spinal Cord Stimulation Waveform for Chronic 
      Neuropathic Low Back Pain: Six-Month Results of a Prospective, Single-Arm, 
      Dose-Response Study.
PG  - 1412-1423
LID - S1094-7159(23)00697-9 [pii]
LID - 10.1016/j.neurom.2023.06.007 [doi]
AB  - OBJECTIVES: The aim of this prospective, single-blinded, dose-response study was 
      to evaluate the safety and efficacy of a novel, paresthesia-free (subperception) 
      spinal cord stimulation (SCS) waveform designed to target dorsal horn dendrites 
      for the treatment of chronic neuropathic low back pain (LBP). MATERIALS AND 
      METHODS: Twenty-seven participants with chronic neuropathic LBP were implanted 
      with a commercial SCS system after a successful trial of SCS therapy. Devices 
      were programmed to deliver the investigative waveform (100 Hz, 1000 mus, T9/T10 
      bipole) at descending stimulation perception threshold amplitudes (80%, 60%, 
      40%). Programs were evaluated at six, ten, and 14 weeks, after which participants 
      selected their preferred program, with more follow-up at 26 weeks (primary 
      outcomes). Participants were blinded to the nature of the programming. Pain score 
      (visual analog scale [VAS]), Brief Pain Inventory (BPI), quality of life 
      (EQ-5D-5L), and health status (36-Item Short Form [SF-36]) were measured at 
      baseline and follow-ups. Responder rate, treatment satisfaction, clinician global 
      impression of change, and adverse events (AEs) also were evaluated. RESULTS: Mean 
      (+/- SD) baseline VAS was 72.5 +/- 11.2 mm. At 26 weeks (n = 26), mean change from 
      baseline in VAS was -51.7 mm (95% CI, -60.7 to -42.7; p < 0.001), with 76.9% of 
      participants reporting >/=50% VAS reduction, and 46.2% reporting >/=80% VAS 
      reduction. BPI, EQ-5D-5L, and SF-36 scores were all statistically significantly 
      improved at 26 weeks (p < 0.001), and 100% of participants were satisfied with 
      their treatment. There were no unanticipated AEs related to the study 
      intervention, device, or procedures. CONCLUSIONS: This novel, paresthesia-free 
      stimulation waveform may be a safe and effective option for patients with chronic 
      neuropathic LBP eligible for SCS therapy and is deliverable by all current 
      commercial SCS systems. CLINICAL TRIAL REGISTRATION: This study is registered on 
      anzctr.org.au with identifier ACTRN12618000647235.
CI  - Copyright (c) 2023 International Neuromodulation Society. Published by Elsevier 
      Inc. All rights reserved.
FAU - Russo, Marc A
AU  - Russo MA
AD  - Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis 
      Research Services, Broadmeadow, New South Wales, Australia; University of 
      Newcastle, School of Biomedical Sciences and Pharmacy, College of Health, 
      Medicine and Wellbeing, Callaghan, New South Wales, Australia. Electronic 
      address: algoguy@gmail.com.
FAU - Volschenk, Willem
AU  - Volschenk W
AD  - Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis 
      Research Services, Broadmeadow, New South Wales, Australia.
FAU - Bailey, Dominic
AU  - Bailey D
AD  - Genesis Research Services, Broadmeadow, New South Wales, Australia.
FAU - Santarelli, Danielle M
AU  - Santarelli DM
AD  - Genesis Research Services, Broadmeadow, New South Wales, Australia.
FAU - Holliday, Elizabeth
AU  - Holliday E
AD  - Hunter Medical Research Institute, New Lambton Heights, New South Wales, 
      Australia.
FAU - Barker, Daniel
AU  - Barker D
AD  - Hunter Medical Research Institute, New Lambton Heights, New South Wales, 
      Australia.
FAU - Dizon, Jason
AU  - Dizon J
AD  - Hunter Medical Research Institute, New Lambton Heights, New South Wales, 
      Australia.
FAU - Graham, Brett
AU  - Graham B
AD  - University of Newcastle, School of Biomedical Sciences and Pharmacy, College of 
      Health, Medicine and Wellbeing, Callaghan, New South Wales, Australia.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20230722
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - Humans
MH  - *Chronic Pain/diagnosis/therapy
MH  - *Low Back Pain/diagnosis/therapy
MH  - Paresthesia/diagnosis/therapy
MH  - *Peripheral Nervous System Diseases
MH  - Prospective Studies
MH  - Quality of Life
MH  - Spinal Cord
MH  - *Spinal Cord Stimulation/adverse effects/methods
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Dorsal horn
OT  - low back pain
OT  - neuropathic pain
OT  - spinal cord stimulation
OT  - stimulation waveform
EDAT- 2023/07/24 13:07
MHDA- 2023/10/23 00:43
CRDT- 2023/07/24 10:32
PHST- 2023/04/25 00:00 [received]
PHST- 2023/06/08 00:00 [revised]
PHST- 2023/06/18 00:00 [accepted]
PHST- 2023/10/23 00:43 [medline]
PHST- 2023/07/24 13:07 [pubmed]
PHST- 2023/07/24 10:32 [entrez]
AID - S1094-7159(23)00697-9 [pii]
AID - 10.1016/j.neurom.2023.06.007 [doi]
PST - ppublish
SO  - Neuromodulation. 2023 Oct;26(7):1412-1423. doi: 10.1016/j.neurom.2023.06.007. 
      Epub 2023 Jul 22.