Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Active SCS

Group Type ACTIVE_COMPARATOR

Active SCS

Intervention Type DEVICE

SCS IPG activated

Inactive SCS

Group Type SHAM_COMPARATOR

Deactivated

Intervention Type DEVICE

SCS IPG deactivated

Interventions

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Active SCS

SCS IPG activated

Intervention Type DEVICE

Deactivated

SCS IPG deactivated

Intervention Type DEVICE

Eligibility Criteria

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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