Status:
COMPLETED
Spinal Cord Stimulation (SCS) Dosing Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Back Pain
Leg Pain
Eligibility:
All Genders
22+ years
Phase:
PHASE4
Brief Summary
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
Detailed Description
This feasibility study assessed the following outcomes: * Patient satisfaction * VAS pain scores
Eligibility Criteria
Inclusion
- 22 years of age or older
- Implanted with a RestoreSensor system (for back and leg pain) for at least 1 month
- Has approproate SCS settings
- Willing and able to provide signed and dated informed consent
- Capable of comprehending and consenting in English
- Capable of getting into the supine and sitting positions
- Willing and able to comply with all study procedures and visits
- On stable (no change in dose, route, or frequency) prescribed pain medications
Exclusion
- Implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system
- Had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study
- Implanted with quadripolar lead
- Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study
- Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
- Has untreated major psychiatric comorbidity
- Has serious drug-related behavioral issues
- Has unresolved major issues of secondary gain
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03284411
Start Date
November 1 2017
End Date
March 15 2019
Last Update
April 15 2020
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Pain Doctors
Chandler, Arizona, United States, 85224
2
Georgia Pain and Wellness Center
Lawrenceville, Georgia, United States, 30046
3
Global Scientific Innovations
Evansville, Indiana, United States, 47714
4
Goodman Campbell Brain and Spine
Indianapolis, Indiana, United States, 46202