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This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients 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 | Other | Spinal cord stimulator is switched off for 12 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability changes | The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off) | 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 | Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain). | 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 |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23750425 | Background | Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6. |
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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 |
| Other |
Spinal cord stimulator is on |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |