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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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To determine the best parameters with various leads to cover back and leg pain and provide best pain relief
Prospective double-blinded trial of patients already implanted with SCS to determine which programming model best controls their back and or leg pain. Baseline visit is 2 weeks after implant. Baseline study data is collected, program #1 is started. The visit @ week 4 collects NRS, changes to program #2. The visit @ week 6 collect NRS, and starts program #3. The visit @ week 8 collects NRS. Subject chooses their preferred program from the previous 3 and uses that for the next 12 weeks. The visit @ week 20 collects NRS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| program 1 | Active Comparator | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs |
|
| program 2 | Active Comparator | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs |
|
| program 3 | Active Comparator | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preset program | Device | Change to different present program using epidural and peripheral lead to cover pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (Pain) | 0 (no pain)- 10 (worst pain imaginable) | Weeks 4, 6 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | percentage of pain relief- self report | weeks 4, 6, and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Center For Advanced Management of Pain | Spartanburg | South Carolina | 29303 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were randomized to 1 of 3 programs. Data were collected every 2 weeks at the completion of each program. Participants chose their preferred program from the previous 3 for the next 12 weeks. |
| 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 | Numeric Rating Scale (Pain) | 0 (no pain)- 10 (worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | Weeks 4, 6 and 8 |
|
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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 | Program 1 | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs preset program: Change to different present program using epidural and peripheral lead to cover pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J Kelby Hutcheson MD | CCAMP | 8642956399 | khutchesonmd@carolinapain.com |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Program 3 | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs preset program: Change to different present program using epidural and peripheral lead to cover pain |
|
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| Secondary | Percent Pain Relief- Subject Self-reported Percentage of Relief With Each Program. | percentage of pain relief- self report | Posted | Mean | Standard Deviation | percentage of pain relief | weeks 4, 6, and 8 |
|
|
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Program 2 | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs preset program: Change to different present program using epidural and peripheral lead to cover pain | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Program 3 | preset program - epidural and peripheral lead to cover pain Randomized selection of epidural and/or peripheral lead programs from 3 possible programs preset program: Change to different present program using epidural and peripheral lead to cover pain | 0 | 40 | 0 | 40 | 0 | 40 |
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| D013812 |
| Therapeutics |