Researchers are evaluating if subjects who have already experienced tonic spinal cord stimulation would have a better pain relief status with burst spinal cord stimulation.
The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Mini™) and are not satisfied with their pain relief status. As part of medical standard of care, patients with already-implanted Eon family tonic implantable pulse generators (IPGs) have the opportunity to experience burst stimulation for 30-Day Trial FDA approved. The aim of the study record patients experience during the 30-Day Trial using standard questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).
Mayo Clinic in Florida
Jacksonville, Florida, United States
Pain intensity
Change in Pain scores using Numeric Rating Scale (1-10)
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Pain quality, intensity and localization
Change in pain perception using Short-Form McGill Pain Questionnaire-2
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Pain perception
Change in pain perception using the Pain Catastrophizing Scale self-reported survey
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Depression
Change in depression scores using Beck Depression Inventory-II self reported survey
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Functioning
Change in patient's functioning using Oswestry Disability Index self-reported survey
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
Participant self-evaluation of Quality of Life
Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participant's impression of Quality of Life
Change in quality of life using Patient Global Impression of Change self-reported survey on activity limitations, symptoms and emotions
Time frame: Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends