A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
TerminatedNot applicableNCT02250469
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System
- Conditions
- Interventions
- Device: Treatment with the Axium SCS system
- Device: Treatment with the Medtronic SCS System
- Sponsor
- Abbott Medical Devices
- Start date
- 2014-09
- Primary completion
- 2016-12
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 exclusion criteria for SCS implantation according to standard criteria 2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months 4. Subject has participated in another clinical study within 30 days 5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02250469