An interventional study of Spinal Cord Stimulation System in Chronic Pain, sponsored by MedtronicNeuro. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-24.
Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable, Interventional, and Treatment
Prospective, multi-center, open-label, post-market study to evaluate the efficacy and energy use of a low energy DTM™ (DTM-LE) SCS therapy for pain relief.
This post market study will measure the following:
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 57 is close to the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
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Exclusion Criteria:
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Device: Spinal Cord Stimulation System
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Also known as: Medtronic Intellis AdaptiveStim Neurostimulation System
Visual Analog Scale (VAS)
To characterize changes in overall (back and leg) pain intensity. Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning "no pain" and 10 cm meaning "worst pain imaginable". Overall pain is defined as a combination of back and leg pain, but not pain from other body parts. Subjects will be asked to report their average pain intensity that is related to their SCS device treatment "in the last 24 hours" by marking a line perpendicular to the VAS line at the point that represents their pain intensity.
Time frame: Baseline to 3 Months
Programming Parameters: Frequency in Hertz (Hz)
To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized using the minimum and maximum frequency across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Time frame: 12 Month
Programming Parameters: Pulse Width in Microseconds (µs)
To characterize programming parameters associated with energy use. Subject's programmed Pulse Width settings will be summarized using the minimum and maximum Pulse Width across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Time frame: 12 Month
Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
To characterize programming parameters associated with energy use. Subject's programmed Amplitude settings will be summarized using the minimum and maximum Amplitude across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Time frame: 12 Month
Programming Parameters: Impedance Range in Ohms
To characterize programming parameters associated with energy use. Subject's programmed Impedance settings will be summarized using the minimum and maximum Impedance across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
Time frame: 12 Month
| Milestone | Spinal Cord Stimulation |
|---|---|
| Started | 57 |
| Completed per protocol at the 12 month visit | 27 |
| Completed | 32 |
| Not completed | 25 |
To characterize changes in overall (back and leg) pain intensity. Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning "no pain" and 10 cm meaning "worst pain imaginable". Overall pain is defined as a combination of back and leg pain, but not pain from other body parts. Subjects will be asked to report their average pain intensity that is related to their SCS device treatment "in the last 24 hours" by marking a line perpendicular to the VAS line at the point that represents their pain intensity.
| Centimeter | Spinal Cord Stimulation |
|---|---|
| Visual Analog Scale (VAS) | -3.9 ± 2.45 |
To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized using the minimum and maximum frequency across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
| Hertz (Hz) | Spinal Cord Stimulation |
|---|---|
| Range Minimum | 250.0 |
| Range Maximum | 300.0 |
To characterize programming parameters associated with energy use. Subject's programmed Pulse Width settings will be summarized using the minimum and maximum Pulse Width across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
| microseconds (µs) | Spinal Cord Stimulation |
|---|---|
| Range Minimum | 200.0 |
| Range Maximum | 200.0 |
To characterize programming parameters associated with energy use. Subject's programmed Amplitude settings will be summarized using the minimum and maximum Amplitude across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
| milliamp (mA) | Spinal Cord Stimulation |
|---|---|
| Range Minimum | 0.70 |
| Range Maximum | 7.3 |
To characterize programming parameters associated with energy use. Subject's programmed Impedance settings will be summarized using the minimum and maximum Impedance across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.
| ohms | Spinal Cord Stimulation |
|---|---|
| Range Minimum | 670.0 |
| Range Maximum | 2,020.0 |
Collected over Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Cord Stimulation | 0/57 (0%) | 1/57 (1.8%) | 12/57 (21.1%) |
| Event | Spinal Cord Stimulation |
|---|---|
| Implant site infectionInfections and infestations | 1/57 |
| Event | Spinal Cord Stimulation |
|---|---|
| Medical device site painGeneral disorders | 2/57 |
| Lead dislodgementProduct Issues | 2/57 |
| Back PainMusculoskeletal and connective tissue disorders | 2/57 |
| Medical device site oedemaGeneral disorders | 1/57 |
| Incision site complicationInjury, poisoning and procedural complications | 1/57 |
| Incision site swellingInjury, poisoning and procedural complications | 1/57 |
| Groin painMusculoskeletal and connective tissue disorders | 1/57 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 1/57 |
| ParesthesiaNervous system disorders | 1/57 |
| Age, Continuous(years) | Spinal Cord Stimulation |
|---|---|
| Mean | 63.2 ± 11.93 |
| Sex: Female, Male(Participants) | Spinal Cord Stimulation |
|---|---|
| Female | 33 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | Spinal Cord Stimulation |
|---|---|
| Hispanic or Latino | 53 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Spinal Cord Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 54 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Spinal Cord Stimulation |
|---|---|
| United States | 57 |
Documents are hosted by the registry — open the source record to download them.
Ran from Nov 2020 to primary completion in Nov 2021, 12 months.
Results were first posted in Feb 2023, 1 year 2 months after primary completion.
Of 87 industry-sponsored interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 12 months is below that.
Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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