Nagy A Mekhail1, Charles E Argoff2, Rod S Taylor3,4, Christian Nasr5, David L Caraway6, Bradford E Gliner6, Jeyakumar Subbaroyan6, Elizabeth S Brooks7. 1. Evidence-Based Pain Management Research, Cleveland Clinic, C25, 9500 Euclid Avenue, Cleveland, OH, 44195, USA. 2. Department of Neurology, Albany Medical College, MC 70, 47 New Scotland Avenue, Albany, NY, 12208, USA. 3. Institute of Health and Well Being, University of Glasgow, 1 Lilybank Gardens, Glasgow G12 8RZ, Scotland, UK. 4. College of Medicine and Health, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter EX1 2LU, England, UK. 5. Department of Endocrinology & Metabolism, Cleveland Clinic, F20, 9500 Euclid Avenue, Cleveland, OH, 44195, USA. 6. Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA. 7. Nevro Corp, 1800 Bridge Parkway, Redwood City, CA, 94065, USA. lisa.brooks@nevro.com.
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).
RCT Entities:
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).
Authors: Michael D Staudt; Tarun Prabhala; Breanna L Sheldon; Nicholas Quaranta; Michael Zakher; Ravneet Bhullar; Julie G Pilitsis; Charles E Argoff Journal: J Diabetes Sci Technol Date: 2020-08-28
Authors: Jeffrey L Chen; Andrew W Hesseltine; Sara E Nashi; Shawn M Sills; Tory L McJunkin; Sandeep Patil; Manish Bharara; David L Caraway; Elizabeth S Brooks Journal: J Diabetes Sci Technol Date: 2021-11-29
Authors: N Strand; C Wie; J Peck; M Maita; N Singh; J Dumbroff; V Tieppo Francio; M Murphy; K Chang; D M Dickerson; J Maloney Journal: Curr Pain Headache Rep Date: 2022-04-06
Authors: Erika A Petersen; Thomas G Stauss; James A Scowcroft; Elizabeth S Brooks; Judith L White; Shawn M Sills; Kasra Amirdelfan; Maged N Guirguis; Jijun Xu; Cong Yu; Ali Nairizi; Denis G Patterson; Kostandinos C Tsoulfas; Michael J Creamer; Vincent Galan; Richard H Bundschu; Neel D Mehta; Dawood Sayed; Shivanand P Lad; David J DiBenedetto; Khalid A Sethi; Johnathan H Goree; Matthew T Bennett; Nathan J Harrison; Atef F Israel; Paul Chang; Paul W Wu; Charles E Argoff; Christian E Nasr; Rod S Taylor; David L Caraway; Nagy A Mekhail Journal: Mayo Clin Proc Innov Qual Outcomes Date: 2022-07-01
Authors: Neil E O'Connell; Michael C Ferraro; William Gibson; Andrew Sc Rice; Lene Vase; Doug Coyle; Christopher Eccleston Journal: Cochrane Database Syst Rev Date: 2021-12-02
Authors: Erika A Petersen; Thomas G Stauss; James A Scowcroft; Elizabeth S Brooks; Judith L White; Shawn M Sills; Kasra Amirdelfan; Maged N Guirguis; Jijun Xu; Cong Yu; Ali Nairizi; Denis G Patterson; Kostandinos C Tsoulfas; Michael J Creamer; Vincent Galan; Richard H Bundschu; Christopher A Paul; Neel D Mehta; Heejung Choi; Dawood Sayed; Shivanand P Lad; David J DiBenedetto; Khalid A Sethi; Johnathan H Goree; Matthew T Bennett; Nathan J Harrison; Atef F Israel; Paul Chang; Paul W Wu; Gennady Gekht; Charles E Argoff; Christian E Nasr; Rod S Taylor; Jeyakumar Subbaroyan; Bradford E Gliner; David L Caraway; Nagy A Mekhail Journal: JAMA Neurol Date: 2021-06-01 Impact factor: 18.302