Trial Outcomes & Findings for Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (NCT NCT03345472)
NCT ID: NCT03345472
Last Updated: 2020-11-03
Results Overview
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.
COMPLETED
NA
175 participants
Baseline to 3 months
2020-11-03
Participant Flow
175 subjects were enrolled. 32 exited before the spinal cord stimulation trial. 143 subjects started the trial and 12 exited during the trial. 131 subjects completed the trial: 117 had a successful high dose (HD) trial; the 14 with unsuccessful HD trial were exited. Of the 117, 14 exited before implant and 103 were implanted (Treated Arm).
Participant milestones
| Measure |
Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Implant to 3 Months
STARTED
|
103
|
|
Implant to 3 Months
COMPLETED
|
99
|
|
Implant to 3 Months
NOT COMPLETED
|
4
|
|
3 Months to 12 Months
STARTED
|
99
|
|
3 Months to 12 Months
COMPLETED
|
91
|
|
3 Months to 12 Months
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Implant to 3 Months
Withdrawal by Subject
|
2
|
|
Implant to 3 Months
Physician Decision
|
1
|
|
Implant to 3 Months
Adverse Event
|
1
|
|
3 Months to 12 Months
Physician Decision
|
3
|
|
3 Months to 12 Months
Lost to Follow-up
|
2
|
|
3 Months to 12 Months
Withdrawal by Subject
|
1
|
|
3 Months to 12 Months
Adverse Event
|
1
|
|
3 Months to 12 Months
Death
|
1
|
Baseline Characteristics
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
Baseline characteristics by cohort
| Measure |
Treated
n=103 Participants
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 13.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=93 Participants
|
|
Years from pain onset to enrollment
|
12.9 years
STANDARD_DEVIATION 11.1 • n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsDemonstrate 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.
Outcome measures
| Measure |
Treated
n=103 Participants
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
|
45.4 units on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsCharacterize 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).
Outcome measures
| Measure |
Treated
n=103 Participants
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Overall Pain Efficacy Responder Rate
|
68.3 percent of subjects who are responder
Interval 59.0 to 77.5
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsCharacterize 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).
Outcome measures
| Measure |
Treated
n=103 Participants
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Low Back Pain Efficacy Responder Rate
|
59.8 percent of subjects who are responders
Interval 49.9 to 69.7
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsCharacterize 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).
Outcome measures
| Measure |
Treated
n=103 Participants
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Leg Pain Efficacy Responder Rate
|
77.4 percent of subjects who are responders
Interval 69.1 to 85.7
|
Adverse Events
Treated
Serious adverse events
| Measure |
Treated
n=103 participants at risk
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
1/103 • Number of events 1 • 12 months post-device activation
Adverse events related to the implanted spinal cord stimulation system, accessories, surgical procedures, and therapy were collected. The sum of subjects affected within each individual event may not add to the total number of subjects affected, as subjects may have experienced more than 1 type of event.
|
Other adverse events
| Measure |
Treated
n=103 participants at risk
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Spinal Cord Stimulation System: Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
|
|---|---|
|
Nervous system disorders
Paraesthesia
|
18.4%
19/103 • Number of events 25 • 12 months post-device activation
Adverse events related to the implanted spinal cord stimulation system, accessories, surgical procedures, and therapy were collected. The sum of subjects affected within each individual event may not add to the total number of subjects affected, as subjects may have experienced more than 1 type of event.
|
|
Product Issues
Device stimulation issue
|
10.7%
11/103 • Number of events 14 • 12 months post-device activation
Adverse events related to the implanted spinal cord stimulation system, accessories, surgical procedures, and therapy were collected. The sum of subjects affected within each individual event may not add to the total number of subjects affected, as subjects may have experienced more than 1 type of event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
9/103 • Number of events 10 • 12 months post-device activation
Adverse events related to the implanted spinal cord stimulation system, accessories, surgical procedures, and therapy were collected. The sum of subjects affected within each individual event may not add to the total number of subjects affected, as subjects may have experienced more than 1 type of event.
|
Additional Information
Stacie Hallaway/Senior Clinical Research Specialist
Medtronic Restorative Therapies Group, Spinal Cord Stimulation
Results disclosure agreements
- Principal investigator is a sponsor employee Per the Clinical Investigation Plan, all proposed publications must be reviewed and approved by Medtronic prior to publication.
- Publication restrictions are in place
Restriction type: OTHER