Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated<br>Enrolled subjects who are implanted with a spinal cord stimulation system that is activated. | Device: Spinal Cord Stimulation System<br>* Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.<br>* Other names: Medtronic Intellis AdaptiveStim neurostimulation system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Pain Intensity on the Visual Analog Scale (0-100) | 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. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Pain Efficacy Responder Rate | 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). | Baseline to 3 months | 
| Low Back Pain Efficacy Responder Rate | 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). | Baseline to 3 months | 
| Leg Pain Efficacy Responder Rate | 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). | Baseline to 3 months |