Chronic Pain
Conditions
Brief summary
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.
Interventions
DEVICETreatment with the Axium SCS system
DEVICETreatment with the Medtronic SCS System
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is appropriate for SCS implantation according to standard criteria 2. Subject is \>18 to \<75 years old 3. Subject is able and willing to comply with the follow-up schedule and protocol 4. Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain 5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain 6. Subject is able to provide written informed consent
Exclusion criteria
1. Subject has no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of Stimulation Induced Paresthesia | 3 Months post implantation | 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 |
| Stability of Stimulation Induced Paresthesia | 3 Months post implantation | 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 |
| Patient Interactions with System | 3 Months post implantation | A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily |
Countries
Netherlands
Outcome results
None listed