Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
- Conditions
- Chronic Pain
- Interventions
- Device: Spinal Cord Stimulation System
- Registration Number
- NCT03345472
- Lead Sponsor
- MedtronicNeuro
- 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 targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated Spinal Cord Stimulation System Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
- Primary Outcome Measures
Name Time Method Change in Overall Pain Intensity on the Visual Analog Scale (0-100) Baseline to 3 months Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS).
The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain.
The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study.
- Secondary Outcome Measures
Name Time Method Overall Pain Efficacy Responder Rate Baseline to 3 months Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS).
The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as \[100\*(Baseline VAS - 3-month VAS)/Baseline VAS\], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.
The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders).Leg Pain Efficacy Responder Rate Baseline to 3 months Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS).
The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as \[100\*(Baseline VAS - 3-month VAS)/Baseline VAS\], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.
The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders).Low Back Pain Efficacy Responder Rate Baseline to 3 months Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS).
The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as \[100\*(Baseline VAS - 3-month VAS)/Baseline VAS\], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.
The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders).
Trial Locations
- Locations (20)
Center for Interventional Pain and Spine
🇺🇸Wilmington, Delaware, United States
Lowcountry Orthopaedics/Coastal Carolina Research Center
🇺🇸Charleston, South Carolina, United States
The Pain Management Center
🇺🇸Voorhees, New Jersey, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Carolina Center for Advanced Management of Pain
🇺🇸Spartanburg, South Carolina, United States
Restore Orthopedics and Spine Center
🇺🇸Orange, California, United States
Pain Care
🇺🇸Stockbridge, Georgia, United States
National Spine and Pain
🇺🇸Oxon Hill, Maryland, United States
Michigan Pain Consultants
🇺🇸Wyoming, Michigan, United States
Comprehensive and Interventional Pain Management
🇺🇸Henderson, Nevada, United States
University of Rochester Neurosurgery Partners Pain Management
🇺🇸Rochester, New York, United States
Carolinas Pain Center
🇺🇸Huntersville, North Carolina, United States
Lehigh Valley Healthcare Network
🇺🇸Allentown, Pennsylvania, United States
Saint Luke's Neurosurgical Associates
🇺🇸Bethlehem, Pennsylvania, United States
Pain Diagnostics and Interventional Care
🇺🇸Sewickley, Pennsylvania, United States
Delaware Valley Pain and Spine Institute
🇺🇸Trevose, Pennsylvania, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States
Carilion Clinic Roanoke Memorial Hospital
🇺🇸Roanoke, Virginia, United States
Northwest Pain Care
🇺🇸Spokane, Washington, United States
Pain Consultants of San Diego
🇺🇸La Mesa, California, United States