12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Academisch Medisch Centrum
Amsterdam, Netherlands
Specificity of Stimulation Induced Paresthesia
A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia
Time frame: 3 Months post implantation
Stability of Stimulation Induced Paresthesia
A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position
Time frame: 3 Months post implantation
Patient Interactions with System
A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily
Time frame: 3 Months post implantation
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