Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Active SCS
Deactivated
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pain focused on measuring Chronic pain, Electric Stimulation Therapy, Neurologic Examination
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Sites / Locations
- Danish Pain Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active SCS
Inactive SCS
Arm Description
Outcomes
Primary Outcome Measures
Change in sensory parameters
Secondary Outcome Measures
Full Information
NCT ID
NCT01261468
First Posted
December 15, 2010
Last Updated
March 14, 2012
Sponsor
Danish Pain Research Center
1. Study Identification
Unique Protocol Identification Number
NCT01261468
Brief Title
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Official Title
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danish Pain Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Electric Stimulation Therapy, Neurologic Examination
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active SCS
Arm Type
Active Comparator
Arm Title
Inactive SCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Active SCS
Intervention Description
SCS IPG activated
Intervention Type
Device
Intervention Name(s)
Deactivated
Intervention Description
SCS IPG deactivated
Primary Outcome Measure Information:
Title
Change in sensory parameters
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troels S Jensen, prof.
Organizational Affiliation
Danish Pain Research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kaare Meier, MD
Organizational Affiliation
Danish Pain Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
11465587
Citation
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.
Results Reference
background
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Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
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