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Title: Effective Relief of Pain and Associated Symptoms With Closed‐Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study
Authors: Russo M 
Cousins M
Brooker C
Taylor N
Boesel T
Sullivan R
Poree L
Shariati NH
Hanson E
Parker J
Keywords: Evoked Compound Action Potential (ECAP)
Spinal Cord Stimulation
back pain
closed loop
feedback stimulation
Issue Date: Jan-2018
Source: 21(1):38-47
Journal Title: Neuromodulation: Technology at the Neural Interface
Abstract: OBJECTIVES: Conventional spinal cord stimulation (SCS) delivers a fixed-input of energy into the dorsal column. Physiologic effects such as heartbeat, respiration, spinal cord movement, and history of stimulation can cause both the perceived intensity and recruitment of stimulation to increase or decrease, with clinical consequences. A new SCS system controls stimulation dose by measuring the recruitment of fibers in the dorsal column and by using the amplitude of the evoked compound action potentials (ECAPs) to maintain stimulation within an individualized therapeutic range. Safety and efficacy of this closed-loop system was evaluated through six-month postimplantation. MATERIALS AND METHODS: Chronic pain subjects with back and/or leg pain who were successfully trialed received a permanent system (Evoke; Saluda Medical, Sydney, Australia). Ratings of pain (100-mm visual analogue scale [VAS] and Brief Pain Instrument [BPI]), quality of life (EuroQol instrument [EQ-5D-5L]), function (Oswestry Disability Index [ODI]), and sleep (Pittsburgh Sleep Quality Index [PSQI]) were collected at baseline and repeated three and six months after implantation. RESULTS: Fifty-one subjects underwent a trial procedure; permanent implants were placed in 36 subjects. The proportion of subjects with ≥50% relief was 92.6% (back) and 91.3% (leg) at three months, and 85.7% (back) and 82.6% (leg) at six months. The proportion with ≥80% pain relief was 70.4% (back) and 56.5% (leg) at three months, and 64.3% (back) and 60.9% (leg) at six months. Statistically significant improvements in mean BPI, EQ-5D-5L, ODI, and PSQI were also observed at both time points. CONCLUSIONS: The majority of subjects experienced profound pain relief at three and six months, providing preliminary evidence for the effectiveness of the closed-loop SCS system. The exact mechanism of action for these outcomes is still being explored, although one likely hypothesis holds that ECAP feedback control may minimize recruitment of Aβ nociceptors and Aδ fibers during daily use of SCS.
DOI: 10.1111/ner.12684
PubMed URL:
Grant Name: ACTRN12615000713594: Avalon Study
Type: Journal Article
Affiliates: Hunter Pain Clinic, Broadmeadow, NSW, Australia
Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital, St Leonards, NSW, Australia
Department of Pain Medicine, Royal North Shore Hospital, St Leonards, NSW, Australia
Northern Clinical School, University of Sydney, Sydney, NSW, Australia
Northern Private Pain Centre, St. Leonards, NSW, Australia
Inner West Pain Center, Newtown, NSW, Australia
Precision Brain, Spine, and Pain Centre, Kew, VIC, Australia
University of California, San Francisco, CA, USA
Saluda Medical Pty Ltd., Artarmon, NSW, Australia
Graduate School of Biomedical Engineering, University of New South Wales, Kensington, NSW, Australia
Study/Trial: Prospective Cohort Study
Appears in Collections:Scholarly and Clinical

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