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Completed

NCT Number: NCT01261468

Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Pain Research Center

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Active SCS

Device

SCS IPG activated

Deactivated

Device

SCS IPG deactivated

Primary outcomes

  1. Change in sensory parameters

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2010
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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