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| ID | Type | Description | Link |
|---|---|---|---|
| 3165-00146B | Other Grant/Funding Number | Independent Research Fund Denmark |
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The aim of the study is to evaluate treatment outcomes of Spinal Cord Stimulation. In the study each patient participates in four test sessions of 4-5 hours. Patients arrive for test days with their stimulation on. In each test session, baseline pain is first evaluated. Then, SCS is regulated (on/off) and patients evaluate their pain intensity immidiately and every 15 minutes during the test sessions. Patients are blinded to the treatment conditions during their participation in the study. At all times, patients can resume their usual treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo condition | Placebo Comparator | The patient is incorrectly told that stimulation is on |
|
| Total treatment | Active Comparator | The patient is correctly told that stimulation is on |
|
| Stimulation treatment | Other | The patient is incorrectly told that stimulation is off |
|
| Control condition | Other | The patient is correctly told that stimulation is off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation ON | Device | Stimulator will be turned on |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients' subjective pain intensity evaluated on a 0-10 Mechanical Visual Analogue Scale (M-VAS) | From enrollment to completion of four test sessions scheduled with a minimum interval of one week between each session. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Emborg, Postdoc | Contact | +4520910215 | chrisemb@psy.au.dk | |
| Lene Vase, Professor | Contact | lenevase@psy.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus N | 8200 | Denmark |
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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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| Stimulation OFF | Device | Stimulation is turned off |
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| Told ON | Device | Verbal suggestion that stimulation is on |
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| Told OFF | Device | Verbal suggestion that stimulation is off |
|