Status:
COMPLETED
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Lead Sponsor:
MedtronicNeuro
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural t...
Eligibility Criteria
Inclusion
- Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
- Presence of low back and leg pain
- Moderate to crippled disability due to pain
- Stable pain medications for back and leg pain for at least 28 days prior to enrollment
- Willing and able to not increase pain medications through the 3-Month visit
Exclusion
- Previously trialed or implanted with stimulator or intrathecal drug delivery system
- Current diagnosis of moderate to severe central lumbar spinal stenosis
- Major psychiatric comorbidity or other progressive diseases
- Serious drug-related behavioral issues
- Pregnant or planning on becoming pregnant
- Unable to achieve supine position
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2019
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03345472
Start Date
November 30 2017
End Date
October 21 2019
Last Update
November 3 2020
Active Locations (20)
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1
Pain Consultants of San Diego
La Mesa, California, United States, 91942-8901
2
Restore Orthopedics and Spine Center
Orange, California, United States, 92868
3
Center for Interventional Pain and Spine
Wilmington, Delaware, United States, 19803
4
Pain Care
Stockbridge, Georgia, United States, 30281-5023