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Only 2 patients enrolled
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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.
The study is a controlled trial with subjects that have an already-implanted SCS device (Eon Miniâ„¢) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulator | Other | Burst neurostimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulator | Device | We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDRâ„¢, Abbott Saint Jude Medical). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Osborne, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058542 | Implantable Neurostimulators |
| ID | Term |
|---|---|
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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|
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 |
| D019736 | Prostheses and Implants |