Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
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| ClinicalTrials.gov Identifier: NCT03345472 |
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Recruitment Status :
Completed
First Posted : November 17, 2017
Results First Posted : March 20, 2020
Last Update Posted : November 3, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Pain | Device: Spinal Cord Stimulation System | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 175 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters |
| Actual Study Start Date : | November 30, 2017 |
| Actual Primary Completion Date : | February 4, 2019 |
| Actual Study Completion Date : | October 21, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
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Device: Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Other Names:
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- Change in Overall Pain Intensity on the Visual Analog Scale (0-100) [ Time Frame: 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.
- Overall Pain Efficacy Responder Rate [ Time Frame: 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).
- Low Back Pain Efficacy Responder Rate [ Time Frame: 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).
- Leg Pain Efficacy Responder Rate [ Time Frame: 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345472
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| Study Director: | Vectors Post Market Clinical Research Study Team | Medtronic Restorative Therapies, Pain Therapy |
Documents provided by MedtronicNeuro:
| Responsible Party: | MedtronicNeuro |
| ClinicalTrials.gov Identifier: | NCT03345472 |
| Other Study ID Numbers: |
MDT17053 |
| First Posted: | November 17, 2017 Key Record Dates |
| Results First Posted: | March 20, 2020 |
| Last Update Posted: | November 3, 2020 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Chronic Pain Pain Neurologic Manifestations |