Chronic Pain
Conditions
Brief summary
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.
Detailed description
This post market study will measure the following: * Visual Analog Scale * Programming Parameters
Interventions
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label 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
* 18 years of age or older * Willing and able to provide signed and dated informed consent * Capable of comprehending and consenting in English * Candidate per labeling for an SCS system as an aid in the management of chronic, intractable pain of the trunk and/or limbs * Has moderate to severe back and leg pain * Stable pain medications for back and leg pain for at least 28 days prior to enrollment * Willing and able to comply with all study procedures and visits * Willing and able to not increase their pain medications through the 3-Month visit * Able to differentiate between pain associated with the indication for SCS implant and other types of pain
Exclusion criteria
* Previously trialed or implanted with a stimulator or intrathecal drug delivery system * Expected to be inaccessible for follow-up * Current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic neurogenic claudication * Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results * If female, is pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study * Has untreated major psychiatric comorbidity * Serious drug-related behavioral issues * Unable to achieve supine or prone position * Classified as vulnerable or requires a legally authorized representative (LAR)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | Baseline to 3 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Programming Parameters: Frequency in Hertz (Hz) | 12 Month | 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. |
| Programming Parameters: Pulse Width in Microseconds (µs) | 12 Month | 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. |
| Programming Parameters: Amplitude (Intensity) in Milliamp (mA) | 12 Month | 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. |
| Programming Parameters: Impedance Range in Ohms | 12 Month | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Stimulation Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Spinal Cord Stimulation System: Implanted rechargeable neurostimulation system (neurostimulator and leads) with on-label stimulation parameters. | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | Spinal Cord Stimulation |
|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 11.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 54 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 12 / 57 |
| serious Total, serious adverse events | 1 / 57 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Stimulation | Visual Analog Scale (VAS) | -3.9 Centimeter | Standard Deviation 2.45 |
Secondary
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
Population: Amplitude (intensity) in milliamp (mA) reported represent the range of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spinal Cord Stimulation | Programming Parameters: Amplitude (Intensity) in Milliamp (mA) | Range Minimum | 0.70 milliamp (mA) |
| Spinal Cord Stimulation | Programming Parameters: Amplitude (Intensity) in Milliamp (mA) | Range Maximum | 7.3 milliamp (mA) |
Secondary
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
Population: Frequencies reported represent the range of the sum of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spinal Cord Stimulation | Programming Parameters: Frequency in Hertz (Hz) | Range Minimum | 250.0 Hertz (Hz) |
| Spinal Cord Stimulation | Programming Parameters: Frequency in Hertz (Hz) | Range Maximum | 300.0 Hertz (Hz) |
Secondary
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
Population: Impedance (ohms) reported represent the range of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spinal Cord Stimulation | Programming Parameters: Impedance Range in Ohms | Range Minimum | 670.0 ohms |
| Spinal Cord Stimulation | Programming Parameters: Impedance Range in Ohms | Range Maximum | 2,020.0 ohms |
Secondary
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
Population: Pulse Width in microseconds (µs) reported represent the range of active programs across all subjects. Patients analyzed included those who completed the study per protocol at the 12 month visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spinal Cord Stimulation | Programming Parameters: Pulse Width in Microseconds (µs) | Range Minimum | 200.0 microseconds (µs) |
| Spinal Cord Stimulation | Programming Parameters: Pulse Width in Microseconds (µs) | Range Maximum | 200.0 microseconds (µs) |