Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Evaluation Study of Patient Experience Comparing Tonic Vs. Burst Spinal Cord Stimulation For Chronic Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spinal Cord Stimulator<br>Burst neurostimulation | Device: Spinal Cord Stimulator<br>* We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).<br>* Other names: Neurostimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Change in Pain scores using Numeric Rating Scale (1-10) | 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 | 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 | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Change in depression scores using Beck Depression Inventory-II self reported survey | 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 | 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 | 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'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 | Participants will be followed at baseline, before and after the 2-3 weeks burst reprograming trial, and 3-8 months after burst trial ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord stimulator (SCS)