An interventional study of Spinal Cord Stimulation System in Chronic Pain, sponsored by MedtronicNeuro. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by MedtronicNeuro · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Device: Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Also known as: Medtronic RestoreSensor SureScan MRI neurostimulation system, Medtronic Intellis AdaptiveStim neurostimulation system
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.
Time frame: Baseline to 3 months
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).
Time frame: 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).
Time frame: 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).
Time frame: Baseline to 3 months
| Milestone | Treated |
|---|---|
| Started | 103 |
| Completed | 99 |
| Not completed | 4 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Adverse event | 1 |
| Milestone | Treated |
|---|---|
| Started | 99 |
| Completed | 91 |
| Not completed | 8 |
| Withdrew: Physician decision | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
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.
| units on a scale | Treated |
|---|---|
| Change in Overall Pain Intensity on the Visual Analog Scale (0-100) | 45.4 ± 2.6 |
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).
| percent of subjects who are responder | Treated |
|---|---|
| Overall Pain Efficacy Responder Rate | 68.3 (59.0 to 77.5) |
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).
| percent of subjects who are responders | Treated |
|---|---|
| Low Back Pain Efficacy Responder Rate | 59.8 (49.9 to 69.7) |
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).
| percent of subjects who are responders | Treated |
|---|---|
| Leg Pain Efficacy Responder Rate | 77.4 (69.1 to 85.7) |
Collected over 12 months post-device activation. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treated | 1/103 (1%) | 1/103 (1%) | 36/103 (35%) |
| Event | Treated |
|---|---|
| Back painMusculoskeletal and connective tissue disorders | 1/103 |
| Event | Treated |
|---|---|
| ParaesthesiaNervous system disorders | 19/103 |
| Device stimulation issueProduct Issues | 11/103 |
| Back painMusculoskeletal and connective tissue disorders | 9/103 |
| Age, Continuous(years) | Treated |
|---|---|
| Mean | 60.8 ± 13.4 |
| Sex: Female, Male(Participants) | Treated |
|---|---|
| Female | 56 |
| Male | 47 |
| Ethnicity (NIH/OMB)(Participants) | Treated |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 93 |
| Unknown or Not Reported | 6 |
| Race (NIH/OMB)(Participants) | Treated |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 92 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Treated |
|---|---|
| United States | 103 |
| Years from pain onset to enrollment(years) | Treated |
|---|---|
| Mean | 12.9 ± 11.1 |
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