Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2020 Jan 15;21(1):87.
doi: 10.1186/s13063-019-4007-y.

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

Nagy A Mekhail  1 , Charles E Argoff  2 , Rod S Taylor  3   4 , Christian Nasr  5 , David L Caraway  6 , Bradford E Gliner  6 , Jeyakumar Subbaroyan  6 , Elizabeth S Brooks  7
Affiliations
Randomized Controlled Trial

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

Nagy A Mekhail et al. Trials. .

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.

Trial registration: ClincalTrials.gov identifier: NCT03228420 (registered 24 July 2017).

PubMed Disclaimer

Conflict of interest statement

NAM served as independent medical monitor for the Senza PDN study. CEA, RST, and CN have received consulting fees from Nevro. DLC, BEG, JS, and ESB are employees of Nevro.

Figures

Fig. 1
Fig. 1
Summary of the sequence of study-related assessments, procedures, and activities
See this image and copyright information in PMC

References

    1. World Health Organization . Global report on diabetes. 2016.
    1. Centers for Disease Control and Prevention . National diabetes statistics report. 2014.
    1. Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18:350–354. doi: 10.1097/00002508-200211000-00002. - DOI - PubMed
    1. Hsieh ST. Pathology and functional diagnosis of small-fiber painful neuropathy. Acta Neurol Taiwanica. 2010;19:82–89. - PubMed
    1. Azhary H, Farooq MU, Bhanushali M, Majid A, Kassab MY. Peripheral neuropathy: differential diagnosis and management. Am Fam Physician. 2010;81:887–892. - PubMed

Publication types

Associated data

Grants and funding