High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)

Mekhail, N. A., Argoff, C. E., Taylor, R. S. , Nasr, C., Caraway, D. L., Gliner, B. E., Subbaroyan, J. and Brooks, E. S. (2020) High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN). Trials, 21, 87. (doi: 10.1186/s13063-019-4007-y) (PMID:31941531) (PMCID:PMC6961392)

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Abstract

Background: Painful diabetic neuropathy (PDN), a debilitating and progressive chronic pain condition that significantly impacts quality of life, is one of the common complications seen with long-standing diabetes mellitus. Neither pharmacological treatments nor low-frequency spinal cord stimulation (SCS) has provided significant and long-term pain relief for patients with PDN. This study aims to document the value of 10-kHz SCS in addition to conventional medical management (CMM) compared with CMM alone in patients with refractory PDN. Methods: In a prospective, multicenter, randomized controlled trial (SENZA-PDN), 216 subjects with PDN will be assigned 1:1 to receive 10-kHz SCS combined with CMM or CMM alone after appropriate institutional review board approvals and followed for 24 months. Key inclusion criteria include (1) symptoms of PDN for at least 12 months, (2) average pain intensity of at least 5 cm—on a 0- to 10-cm visual analog scale (VAS)—in the lower limbs, and (3) an appropriate candidate for SCS. Key exclusion criteria include (1) large or gangrenous ulcers or (2) average pain intensity of at least 3 cm on VAS in the upper limbs or both. Along with pain VAS, neurological assessments, health-related quality of life, sleep quality, and patient satisfaction will be captured. The primary endpoint comparing responder rates (≥50% pain relief) and safety rates between the treatment groups will be assessed at 3 months. Several secondary endpoints will also be reported on. Discussion: Enrollment commenced in 2017 and was completed in 2019. This study will help to determine whether 10-kHz SCS improves clinical outcomes and health-related quality of life and is a cost-effective treatment for PDN that is refractory to CMM.

Item Type:Articles
Additional Information:This study is funded by Nevro.
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Taylor, Professor Rod
Authors: Mekhail, N. A., Argoff, C. E., Taylor, R. S., Nasr, C., Caraway, D. L., Gliner, B. E., Subbaroyan, J., and Brooks, E. S.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO SPHSU
Journal Name:Trials
Publisher:BMC
ISSN:1745-6215
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2020 The Authors
First Published:First published in Trials 21:87
Publisher Policy:Reproduced under a Creative Commons License

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