Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
1 other identifier
interventional
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Apr 2011
Shorter than P25 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 15, 2012
March 1, 2012
8 months
December 15, 2010
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in sensory parameters
24 hours
Study Arms (2)
Active SCS
ACTIVE COMPARATORInactive SCS
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- minimum age 18
- able to understand participant information and cooperate at the neurological examination
- uncomplicated treatment with spinal cord stimulation for at least 3 months
- pain in only one extremity
- treatment effect in only one extremity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish Pain Research Center
Aarhus C, 8000, Denmark
Related Publications (1)
Kemler MA, Reulen JP, Barendse GA, van Kleef M, de Vet HC, van den Wildenberg FA. Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. Anesthesiology. 2001 Jul;95(1):72-80. doi: 10.1097/00000542-200107000-00016.
PMID: 11465587BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Troels S Jensen, prof.
Danish Pain Research Center
- PRINCIPAL INVESTIGATOR
Kaare Meier, MD
Danish Pain Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 16, 2010
Study Start
April 1, 2011
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 15, 2012
Record last verified: 2012-03