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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation | Experimental | Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation System | Device | Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Restorative Therapies Group Restorative Therapies Group | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPM Medical Group | Walnut Creek | California | 94598 | United States | ||
| Goodman Campbell Brain and Spine |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Centimeter | Baseline to 3 Months |
|
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.
All device-related, procedure-related, and therapy-related adverse events will be considered reportable for this study. Adverse events will be collected on an Adverse Event Case Report Form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device site oedema | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DTM-LE Clinical Research Study Team | Medtronic | 763-514-4000 | rs.scsresearch@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2021 | Jan 10, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 28, 2022 | Jan 10, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. | 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. | 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. | 12 Month |
| Carmel |
| Indiana |
| 46032 |
| United States |
| Drez One LLC | Somerset | Kentucky | 42503 | United States |
| Carolinas Pain Center | Huntersville | North Carolina | 28078 | United States |
| Novant Health | Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma Pain Physicians | Oklahoma City | Oklahoma | 73120 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 17604 | United States |
| Pain Diagnostics and Interventional Care | Sewickley | Pennsylvania | 15143 | United States |
| Delaware Valley Pain and Spine Institute | Trevose | Pennsylvania | 19053 | United States |
| The Woodlands Pain Institute | Conroe | Texas | 77384 | United States |
| The Burkhart Research Institute for Orthopaedics | San Antonio | Texas | 78216 | United States |
| Sprintz Center for Pain | Shenandoah | Texas | 77384 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | 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. | Posted | Number | Hertz (Hz) | 12 Month |
|
|
|
| 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. | 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. | Posted | Number | microseconds (µs) | 12 Month |
|
|
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| 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. | 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. | Posted | Number | milliamp (mA) | 12 Month |
|
|
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| 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. | 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. | Posted | Number | ohms | 12 Month |
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| 0 |
| 57 |
| 1 |
| 57 |
| 12 |
| 57 |
| Medical device site pain | General disorders | Systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision site swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lead dislodgement | Product Issues | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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