Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters

D

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

15 participants in 2 patient groups

Active SCS
Active Comparator group
Treatment:
Device: Active SCS
Inactive SCS
Sham Comparator group
Treatment:
Device: Deactivated

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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