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Clinical Trials/NCT01261468
NCT01261468
Completed
Not Applicable

Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Danish Pain Research Center1 site in 1 country15 target enrollmentApril 2011
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Danish Pain Research Center
Enrollment
15
Locations
1
Primary Endpoint
Change in sensory parameters
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
December 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Danish Pain Research Center
Responsible Party
Sponsor

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

  • Not provided

Outcomes

Primary Outcomes

Change in sensory parameters

Time Frame: 24 hours

Study Sites (1)

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