Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT01261468
First received: December 15, 2010
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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 Intervention
Chronic Pain
Device: Active SCS
Device: Deactivated

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Resource links provided by NLM:


Further study details as provided by Danish Pain Research Center:

Primary Outcome Measures:
  • Change in sensory parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active SCS Device: Active SCS
SCS IPG activated
Sham Comparator: Inactive SCS Device: Deactivated
SCS IPG deactivated

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261468

Locations
Denmark
Danish Pain Research Center
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
Investigators
Study Director: Troels S Jensen, prof. Danish Pain Research Center
Principal Investigator: Kaare Meier, MD Danish Pain Research Center
  More Information

Publications:
Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT01261468     History of Changes
Other Study ID Numbers: SCS-24h
Study First Received: December 15, 2010
Last Updated: March 14, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Danish Pain Research Center:
Chronic pain
Electric Stimulation Therapy
Neurologic Examination

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014