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Business temporarily suspended study January 2023 with intent to include additional cohorts in future. For business reasons, study terminated April 2024.
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To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Low Energy - Continuous | Experimental | Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes |
|
| Cohort 2: Interleaving | Experimental | Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes |
|
| Cohort 3: Cycling Evolve | Experimental | Subjects will be programmed to high dose (HD) stimulation with various cycling parameters |
|
| Cohort 4: Low Energy Cycling 1 | Experimental | Effects of decreased pulse widths with increased frequency - with and without cycling parameters |
|
| Cohort 5: Low Energy Cycling 2 | Experimental | Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | Programming |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) - Cohort 1 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 5 months |
| Numeric Pain Rating Scale (NPRS) - Cohort 2 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 2 months |
| Numeric Pain Rating Scale (NPRS) - Cohort 3 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 3 months |
| Numeric Pain Rating Scale (NPRS) - Cohort 4 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 5 months |
| Numeric Pain Rating Scale - Cohort 5 |
Not provided
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pain and Supportive Care | Phoenix | Arizona | 85028 | United States | ||
| Goodman Campbell Brain and Spine |
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Some subjects participated in more than one cohort during the lifecycle of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Low Energy - Continuous | Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes Spinal Cord Stimulation: Programming |
| FG001 | Cohort 2: Interleaving | Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes Spinal Cord Stimulation: Programming |
| FG002 | Cohort 3: Cycling Evolve | Subjects will be programmed to high dose (HD) stimulation with various cycling parameters Spinal Cord Stimulation: Programming |
| FG003 | Cohort 4: Low Energy Cycling 1 | Effects of decreased pulse widths with increased frequency - with and without cycling parameters Spinal Cord Stimulation: Programming |
| FG004 | Cohort 5: Low Energy Cycling 2 | Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4) Spinal Cord Stimulation: Programming |
| FG005 | Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | Effects of decreased frequency and therapy cycling parameters Spinal Cord Stimulation: Programming |
| FG006 | Cohort 7: Super Cycle | Effects of longer cycle duration Spinal Cord Stimulation: Programming |
| FG007 | Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | Effects of integrating Neuro Sense into DTM programming Spinal Cord Stimulation: Programming |
| FG008 | Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | Characteristics of vital signs in DPN participants Spinal Cord Stimulation: Programming |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1: Low Energy -Continuous |
|
| ||||||||||||||||||
| Cohort 2: Interleaving |
| |||||||||||||||||||
| Cohort 3: Cycling Evolve |
| |||||||||||||||||||
| Cohort 4: Low Energy Cycling 1 |
| |||||||||||||||||||
| Cohort 5: Low Energy Cycling 2 |
| |||||||||||||||||||
| Cohort 6: DTM-LE SCS |
| |||||||||||||||||||
| Cohort 7: Super Cycle |
| |||||||||||||||||||
| Cohort 8: DTM for NS |
| |||||||||||||||||||
| Cohort 9: DPN Flow |
|
Some participants were in more than one cohort; total enrollment is 100 participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Low Energy - Continuous | Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes Spinal Cord Stimulation: Programming |
| BG001 | Cohort 2: Interleaving |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. |
| 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 | Numeric Pain Rating Scale (NPRS) - Cohort 1 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 5 months |
|
Cohort 1: 4.4 months Cohort 2: 1.5 months Cohort 3: 3.0 months Cohort 4: 2.1 months Cohort 5: 2.8 months Cohort 6: 6.8 months Cohort 7: 7.8 months Cohort 8: 0.5 months Cohort 9: 0.6 months
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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 | Cohort 1: Low Energy - Continuous | Subjects will be programmed to a specific frequency with a long pulse width at various amplitudes Spinal Cord Stimulation: Programming |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SCS Research Study Team | Medtronic Neuromodulation | 800-633-8766 | rs.scsresearch@medtronic.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2022 | Dec 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2022 | Dec 6, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
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| Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | Experimental | Effects of decreased frequency and therapy cycling parameters |
|
| Cohort 7: Super Cycle | Experimental | Effects of longer cycle duration |
|
| Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | Experimental | Effects of integrating Neuro Sense into DTM programming |
|
| Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | Experimental | Characteristics of vital signs in DPN participants |
|
To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. |
| Up to 5 months |
| Numeric Pain Rating Scale (NPRS) - Cohort 6 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 7 months |
| Numeric Pain Rating Scale (NPRS) - Cohort 7 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 8 months |
| Numeric Pain Rating Scale (NPRS) - Cohort 8 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 0.5 months |
| Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Up to 1 month |
| Carmel |
| Indiana |
| 46032 |
| United States |
| Drez One | Somerset | Kentucky | 42503 | United States |
| Twin Cities Pain Clinic | Edina | Minnesota | 55439 | United States |
| Regional Brain and Spine | Cape Girardeau | Missouri | 63701 | United States |
| Carolinas Research Institute | Huntersville | North Carolina | 28078 | United States |
| Center for Interventional Pain and Spine | Lancaster | Pennsylvania | 17601 | United States |
| Pain Diagnostics and Interventional Care | Sewickley | Pennsylvania | 15143 | United States |
| Northwest Pain Care | Spokane | Washington | 99201 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes
Spinal Cord Stimulation: Programming
| BG002 | Cohort 3: Cycling Evolve | Subjects will be programmed to high dose (HD) stimulation with various cycling parameters Spinal Cord Stimulation: Programming |
| BG003 | Cohort 4: Low Energy Cycling 1 | Effects of decreased pulse widths with increased frequency - with and without cycling parameters Spinal Cord Stimulation: Programming |
| BG004 | Cohort 5: Low Energy Cycling 2 | Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4) Spinal Cord Stimulation: Programming |
| BG005 | Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | Effects of decreased frequency and therapy cycling parameters Spinal Cord Stimulation: Programming |
| BG006 | Cohort 7: Super Cycle | Effects of longer cycle duration Spinal Cord Stimulation: Programming |
| BG007 | Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | Effects of integrating Neuro Sense into DTM programming Spinal Cord Stimulation: Programming |
| BG008 | Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | Characteristics of vital signs in DPN participants Spinal Cord Stimulation: Programming |
| BG009 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Indication | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Count of Participants | Participants |
|
| Years Since Onset of Chronic Pain | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Mean | Standard Deviation | years |
|
| Days Since Implant to Enrollment | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Mean | Standard Deviation | days |
|
| Years Since Implant to Enrollment | Some participants joined a new cohort once their current cohort was completed, and they met the new cohort guidelines. Therefore, there were participants who ended up in more than one of the 9 cohorts. There were a total of 100 unique participants in this study. | Mean | Standard Deviation | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Numeric Pain Rating Scale (NPRS) - Cohort 2 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 months |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) - Cohort 3 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 3 months |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) - Cohort 4 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 5 months |
|
|
|
| Primary | Numeric Pain Rating Scale - Cohort 5 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 5 months |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) - Cohort 6 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 7 months |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) - Cohort 7 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 8 months |
|
|
|
| Primary | Numeric Pain Rating Scale (NPRS) - Cohort 8 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 0.5 months |
|
|
|
| Primary | Numeric Pain Rating Scale at Enrollment (NPRS) - Cohort 9 | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded once or daily over a period of time, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score prior to the scheduled visit will be used for analysis. | Number analyzed refers to patients with measure available. | Posted | Mean | Standard Deviation | score on a scale | Up to 1 month |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | Cohort 2: Interleaving | Determine effects of delivering ping pulses combined with governed pulses while using separate sets of electrodes Spinal Cord Stimulation: Programming | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Cohort 3: Cycling Evolve | Subjects will be programmed to high dose (HD) stimulation with various cycling parameters Spinal Cord Stimulation: Programming | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Cohort 4: Low Energy Cycling 1 | Effects of decreased pulse widths with increased frequency - with and without cycling parameters Spinal Cord Stimulation: Programming | 0 | 15 | 0 | 15 | 4 | 15 |
| EG004 | Cohort 5: Low Energy Cycling 2 | Effects of decreased pulse widths with increased frequency - with and without cycling parameters (different pulse widths and frequencies than Cohort 4) Spinal Cord Stimulation: Programming | 0 | 15 | 0 | 15 | 2 | 15 |
| EG005 | Cohort 6: Differential Targeted Multiplexed-Low Energy Spinal Cord Stimulation (DTM-LE SCS) | Effects of decreased frequency and therapy cycling parameters Spinal Cord Stimulation: Programming | 0 | 22 | 0 | 22 | 3 | 22 |
| EG006 | Cohort 7: Super Cycle | Effects of longer cycle duration Spinal Cord Stimulation: Programming | 0 | 17 | 0 | 17 | 3 | 17 |
| EG007 | Cohort 8: Differential Targeted Multiplexed (DTM) for Neuro Sense (NS) | Effects of integrating Neuro Sense into DTM programming Spinal Cord Stimulation: Programming | 0 | 4 | 0 | 4 | 0 | 4 |
| EG008 | Cohort 9: Diabetic Peripheral Neuropathy (DPN) Flow | Characteristics of vital signs in DPN participants Spinal Cord Stimulation: Programming | 0 | 11 | 0 | 11 | 0 | 11 |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Device stimulation issue | Product Issues | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Medical device site irritation | General disorders | MedDRA | Systematic Assessment |
|
| Medical device site pain | General disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
|
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| Unknown or Not Reported |
|
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|
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| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
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|
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|
|
|
|
| Degenerative Disc Disease |
|
| Epidural Fibrosis |
|
| Failed Back Surgery Syndrome |
|
| Multiple Back Operations |
|
| Peripheral Causalgia |
|
| Postlaminectomy Pain |
|
| Radicular Pain Syndrome |
|
| Unsuccessful Disc Surgery |
|
| Other |
|
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|
| Title | Measurements |
|---|---|
|
|
| Follow Up 2 (Came in at Cycling ON) |
|
|
| Follow Up 3 (Came in at Cycling ON) |
|
|
| Follow Up 4 (Came in at Cycling ON) |
|
|
| Follow Up 5 (Came in at Cycling ON) |
|
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| Final Study Visit (Came in at Cycling ON) |
|
|
|
| Low Energy 1, cycling ON (Period 2) |
|
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| Low Energy 1, cycling ON (Period 3) |
|
|
| Low Energy 2, cycling off (Period 4) |
|
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| Low Energy 2, cycling ON (Period 5) |
|
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| Low Energy 2, cycling ON (Period 6) |
|
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| Low Energy 2, cycling ON (Period 7) |
|
|
|
| Low Energy 1, cycling ON (Period 2) |
|
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| Low Energy 1, cycling ON (Period 3) |
|
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| Low Energy 2, cycling off (Period 4) |
|
|
| Low Energy 2, cycling ON (Period 5) |
|
|
| Low Energy 2, cycling ON (Period 6) |
|
|
|
| DTM-LE Continuous (Follow-up 2) |
|
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| DTM-LE Duty Cycle Enabled* (Follow-up 3) |
|
|
| 2-Week Follow-up (Follow-up 4) |
|
|
| 1-Month Follow-up (Follow-up 5) |
|
|
| 2-Month Follow-up (Follow-up 6) |
|
|
| 3-Month Follow-up (Final Study Visit) |
|
|
|
| Optimization Visit 1 (Follow Up 1) |
|
|
| Optimization Visit 2 (Follow Up 2) |
|
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| Optimization Visit 3 (Follow Up 3) |
|
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| Start of Titration Phase (Follow Up 4) |
|
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| 2-Week Titration Phase (Follow Up 5) |
|
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| 4-Week Titration Phase (Follow Up 6) |
|
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| End of Titration Phase (Follow Up 7) |
|
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| 1-Month Post Titration Phase (Follow Up 8) |
|
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| 2-Months Post Titration Phase (Follow Up 9) |
|
|
| 3-Months Post Titration Phase (Final Study Visit) |
|
|