Status:
TERMINATED
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
Lead Sponsor:
Abbott Medical Devices
Conditions:
Chronic Pain
Eligibility:
All Genders
18-75 years
Phase:
NA
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 tre...
Eligibility Criteria
Inclusion
- Subject is appropriate for SCS implantation according to standard criteria
- Subject is \>18 to \<75 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Subject has chronic (\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain
- Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain
- Subject is able to provide written informed consent
Exclusion
- Subject has no other exclusion criteria for SCS implantation according to standard criteria
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- Subject has participated in another clinical study within 30 days
- Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02250469
Start Date
September 1 2014
End Date
December 1 2016
Last Update
November 9 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Academisch Medisch Centrum
Amsterdam, Netherlands