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12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axium SCS System | Active Comparator | Implantation with the Axium Neurostimulator |
|
| Medtronic SCS System | Active Comparator | Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with the Axium SCS system | Device |
| ||
| Treatment with the Medtronic SCS System |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of Stimulation Induced Paresthesia | A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia | 3 Months post implantation |
| Stability of Stimulation Induced Paresthesia | A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position | 3 Months post implantation |
| Patient Interactions with System | A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily | 3 Months post implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M W Hollmann, Prof | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum | Amsterdam | Netherlands |
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| Device |
|
| 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 |
|---|---|
| D013812 | Therapeutics |
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