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The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.
This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.
Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) | Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable" | Within 6 months post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Yearwood, MD | Comprehensive Pain and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Pain Management and Rehabilitation | Daphne | Alabama | 36526 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation Programming Parameters | Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulation Programming Parameters | Spinal Cord Stimulation (SCS) Treatment Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain Severity, as Measured on the 11-point (0-10) Numerical Rating Scale (NRS) | Pain severity as measured by NRS quantifies pain, where 0 is "no pain" and 10 is "worst pain imaginable" | Posted | Mean | Standard Deviation | Percent Change in Pain Rating | Within 6 months post-implantation |
|
|
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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 Programming Parameters | Spinal Cord Stimulation (SCS) Treatment Group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stimulation not tolerated | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brad Hershey, MS | Boston Scientific | (661) 949-4828 | Brad.Hershey@bsci.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| 0 |
| 21 |
| 2 |
| 21 |
| Pain | Nervous system disorders | Non-systematic Assessment |
|
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