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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, Nagy A; Argoff, Charles E; Taylor, Rod S; Nasr, Christian; Caraway, David L; Gliner, Bradford E; Subbaroyan, Jeyakumar; Brooks, Elizabeth S.
Afiliação
  • Mekhail NA; Evidence-Based Pain Management Research, Cleveland Clinic, C25, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
  • Argoff CE; Department of Neurology, Albany Medical College, MC 70, 47 New Scotland Avenue, Albany, NY, 12208, USA.
  • Taylor RS; Institute of Health and Well Being, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, Scotland, UK.
  • Nasr C; College of Medicine and Health, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter EX1 2LU, England, UK.
  • Caraway DL; Department of Endocrinology & Metabolism, Cleveland Clinic, F20, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
  • Gliner BE; Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA.
  • Subbaroyan J; Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA.
  • Brooks ES; Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA.
Trials ; 21(1): 87, 2020 Jan 15.
Article em En | MEDLINE | ID: mdl-31941531
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).
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neuropatias Diabéticas / Dor Crônica / Estimulação da Medula Espinal Tipo de estudo: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neuropatias Diabéticas / Dor Crônica / Estimulação da Medula Espinal Tipo de estudo: Clinical_trials / Etiology_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article