Chronic Pain
Conditions
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.
Interventions
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 3 Months to 12 Months | Adverse Event | 1 |
| 3 Months to 12 Months | Death | 1 |
| 3 Months to 12 Months | Lost to Follow-up | 2 |
| 3 Months to 12 Months | Physician Decision | 3 |
| 3 Months to 12 Months | Withdrawal by Subject | 1 |
| Implant to 3 Months | Adverse Event | 1 |
| Implant to 3 Months | Physician Decision | 1 |
| Implant to 3 Months | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treated |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Region of Enrollment United States | 103 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 47 Participants |
| Years from pain onset to enrollment | 12.9 years STANDARD_DEVIATION 11.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 103 |
| other Total, other adverse events | 36 / 103 |
| serious Total, serious adverse events | 1 / 103 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treated | Change in Overall Pain Intensity on the Visual Analog Scale (0-100) | 45.4 units on a scale | Standard Error 2.6 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Leg Pain Efficacy Responder Rate | 77.4 percent of subjects who are responders |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Low Back Pain Efficacy Responder Rate | 59.8 percent of subjects who are responders |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated | Overall Pain Efficacy Responder Rate | 68.3 percent of subjects who are responder |