The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
497
Spinal cord stimulation system (SCS) is an approved system to manage chronic intractable pain of the limbs and/or leg by delivering electrical stimulation using implantable leads and rechargeable implantable pulse generator (IPG) with 16 output channels. The IPG is implanted in a subcutaneous pocket and is capable of stimulating the spinal cord nerves when used with one or two 8-contact percutaneous or paddle leads.
Neuroversion, Inc.
Anchorage, Alaska, United States
ACTIVE_NOT_RECRUITINGMichigan Pain Specialists
Ann Arbor, Michigan, United States
RECRUITINGHenry Ford Health
West Bloomfield, Michigan, United States
Trial success rate/Responder rate
Percentage of patients with a successful trial phase (responder rate) i.e. at least 50% reduction in patient-reported overall pain relief.
Time frame: 2 weeks
Patient-reported overall pain relief
The average percentage of patient-reported pain relief at 3,6 and 12 months.
Time frame: 12 months
Leg pain
Leg pain will be assessed using a 10 cm Visual Analog Scale (VAS) with 0 indicating no pain and 10 indicating the worst pain. Following outcome measures will be derived from the VAS score on leg pain. * Responder rate for leg pain i.e. percentage of patients who experience at least 50% reduction in leg pain compared to Baseline at 3, 6, and 12 months. * Change from Baseline in mean leg pain at 3, 6, and 12 months * Percentage change from Baseline in mean leg pain at 3, 6, and 12 months
Time frame: 12 months
Quality of life measure
Change from baseline in quality of life at 3, 6 and 12 months will be assessed using the EQ-5D-5L questionnaire.
Time frame: 12 months
Pain Inventory
Change from baseline in pain symptoms at 3, 6 and 12 months assessed by 11-point BPI-DPN (Brief Pain Inventory for Diabetic Peripheral Neuropathy) pain scale, with 0 indicating no pain and 10 indicating worst pain.
Time frame: 12 months
Global impression of change in health status
The patient's general health status at 3, 6 and 12 months will be assessed both by the patients themselves as well as the study investigators using the 7-point PGIC (Patient Global Impression of Change) and the CGIC (Clinician Global Impression of Change) instrument respectively. Responses for this questionnaire range from "no change (or condition has got worse)" to "a great deal better".
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Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGClinical Investigations, LLC
Edmond, Oklahoma, United States
ACTIVE_NOT_RECRUITINGColumbia Pain Management
Milwaukie, Oregon, United States
RECRUITINGWellSpan Interventional Pain Specialists
York, Pennsylvania, United States
RECRUITINGVirginia Interventional Pain & Spine Centers
Roanoke, Virginia, United States
RECRUITINGTime frame: 12 months