Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2011

Interventions

  • Device: Active SCS
    • SCS IPG activated
  • Device: Deactivated
    • SCS IPG deactivated

Arms, Groups and Cohorts

  • Active Comparator: Active SCS
  • Sham Comparator: Inactive SCS

Clinical Trial Outcome Measures

Primary Measures

  • Change in sensory parameters
    • Time Frame: 24 hours

Participating in This Clinical Trial

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:

-

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Pain Research Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Troels S Jensen, prof., Study Director, Danish Pain Research Center
    • Kaare Meier, MD, Principal Investigator, Danish Pain Research Center

References

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.

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