Chronic Pain
Conditions
Keywords
Spinal cord stimulator (SCS)
Brief summary
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.
Detailed description
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.
Interventions
DEVICESpinal Cord Stimulator
We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females ≥18 years-old * Diagnosed with chronic pain * Have an already-implanted Eon Family IPG for a minimum period of 6 months * Are interested in trying burst technology by reprograming their IPG for 2-3 weeks according to the 30-Day Trial standard of care * Signed informed consent
Exclusion criteria
* Subject's overall Beck Depression Inventory II Score is \>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit; If subjects scores indicate suicidal thoughts, subject is going to be evaluated further if they will be subjects to Baker's act * Subject is currently receiving, applying or considering seeking disability payments, workers compensation, or is involved in disability litigation * Subject has an infusion pump or any other implantable neurostimulator device * Subjects with a separate, concurrent, clinically significant or disabling chronic pain problem that requires additional medical or surgical treatment * Subject's pain originates from peripheral vascular disease * Subject is immunocompromised * Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection * Subject has history of cancer requiring active treatment in the last 6 months * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in Pain scores using Numeric Rating Scale (1-10) |
| Pain quality, intensity and localization | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in pain perception using Short-Form McGill Pain Questionnaire-2 |
| Pain perception | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in pain perception using the Pain Catastrophizing Scale self-reported survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in depression scores using Beck Depression Inventory-II self reported survey |
| Participant's impression of Quality of Life | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in quality of life using Patient Global Impression of Change self-reported survey on activity limitations, symptoms and emotions |
| Functioning | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in patient's functioning using Oswestry Disability Index self-reported survey |
| Participant self-evaluation of Quality of Life | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | Change in quality of life scores using self-reported questionnaire Short-From-36 Health Survey |
Countries
United States
Outcome results
None listed