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| Name | Class |
|---|---|
| The eNose Company | INDUSTRY |
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This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCS off | Experimental |
| |
| SCS on | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCS is switched off | Device | Spinal cord stimulator is switched off for 12 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled breath changes | The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose. | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity scores using the Visual Analogue Scale | Pain intensity score on that time on a Visual Analogue Scale (VAS) ranging from zero (no pain) towards 10 (worst possible pain) for the pain intensity. | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten Moens, Prof. dr. | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Jette | 1090 | Belgium |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| SCS is switched on |
| Device |
Spinal cord stimulator is functioning |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |