Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
|ClinicalTrials.gov Identifier: NCT01261468|
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : March 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Device: Active SCS Device: Deactivated||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|Active Comparator: Active SCS||
Device: Active SCS
SCS IPG activated
|Sham Comparator: Inactive SCS||
SCS IPG deactivated
- Change in sensory parameters [ Time Frame: 24 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|