Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST).
Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.
After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.
The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
|Official Title:||Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters|
- Change in sensory parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Active SCS||
Device: Active SCS
SCS IPG activated
|Sham Comparator: Inactive SCS||
SCS IPG deactivated
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261468
|Danish Pain Research Center|
|Aarhus C, Denmark, 8000|
|Study Director:||Troels S Jensen, prof.||Danish Pain Research Center|
|Principal Investigator:||Kaare Meier, MD||Danish Pain Research Center|