Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

Danish Pain Research Center

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Deactivated; Device: Active SCS

Study type: Interventional

Funder types: Other

Identifiers

NCT01261468

SCS-24h

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Active SCS

Active Comparator group

Treatment:

Device: Active SCS

Inactive SCS

Sham Comparator group

Treatment:

Device: Deactivated