Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

March 14, 2012 updated by: Danish Pain Research Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Danish Pain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active SCS
Device: Active SCS
SCS IPG activated
Sham Comparator: Inactive SCS
Device: Deactivated
SCS IPG deactivated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sensory parameters
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Pain Research Center

Investigators

  • Study Director: Troels S Jensen, prof., Danish Pain Research Center
  • Principal Investigator: Kaare Meier, MD, Danish Pain Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 15, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCS-24h

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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