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The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain.
Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Spinal Cord Stimulation System | Device | Stimulation on throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. | Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine" | 1 year |
| Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. | Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine" | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
1. Enrollment in any research that would conflict with study requirements.
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| Name | Affiliation | Role |
|---|---|---|
| Ramsin Benyamin, MD | Millenium Pain Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Cullman | Alabama | 35055 | United States | ||
| Research Center |
Efforts were made but the information is not accessible at this time. Hence assignment not available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spinal Cord Stimulation | Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Daphne |
| Alabama |
| 36526 |
| United States |
| Research Center | Huntsville | Alabama | 35801 | United States |
| Research Center | Mesa | Arizona | 85206 | United States |
| Research Center | Los Angeles | California | 90095 | United States |
| Research Center | Pasadena | California | 91105 | United States |
| Research Center | San Diego | California | 92108 | United States |
| Research Center | Westminster | Colorado | 80401 | United States |
| Research Center | Jacksonville | Florida | 32224 | United States |
| Research Center | Jupiter | Florida | 33477 | United States |
| Research Center | Lewiston | Idaho | 83501 | United States |
| Research Center | Bloomington | Illinois | 61701 | United States |
| Research Center | Chicago | Illinois | 60611 | United States |
| Research Center | Oak Brook | Illinois | 60707 | United States |
| Research Center | Merrillville | Indiana | 46410 | United States |
| Research Center | Valparaiso | Indiana | 46410 | United States |
| Research Center | Boston | Massachusetts | 02215 | United States |
| Research Center | Pittsfield | Massachusetts | 01201 | United States |
| Research Center | Rochester | Minnesota | 55904 | United States |
| Research Center | Billings | Montana | 59101 | United States |
| Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Research Center | Hamilton | Ohio | 45011 | United States |
| Research Center | Eugene | Oregon | 97401 | United States |
| Research Center | Allentown | Pennsylvania | 18104 | United States |
| Research Center | Philadelphia | Pennsylvania | 19107 | United States |
| Research Center | Spartanburg | South Carolina | 29302 | United States |
| Research Center | Murray | Utah | 84107 | United States |
| Research Center | Provo | Utah | 84604 | United States |
| Research Center | Cudahy | Wisconsin | 53220 | United States |
| Research Center | Rice Lake | Wisconsin | 54868 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
Efforts were made but the information is not accessible at this time. Hence baseline measures not reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spinal Cord Stimulation | Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| ||||||||||||||||||||||
| Sex: Female, Male |
| ||||||||||||||||||||||
| Region of Enrollment | 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 | Effectiveness of SCS Stimulation in Reducing Back Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. | Effectiveness of SCS stimulation in reducing back pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine" | Efforts were made but the information is not accessible at this time. Hence outcome measures not reported. | Posted | 1 year |
|
| |||||||||||||||||||
| Primary | Effectiveness of SCS Stimulation in Reducing Leg Pain Associated With Failed Back Surgery Syndrome After 12 Months of Use. | Effectiveness of SCS stimulation in reducing leg pain associated with Failed Back Surgery Syndrome after 12 months of use as measured by 0 - 10 numerical rating scale (Numerical Rating Scale, NRS), where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine" | Efforts were made but the information is not accessible at this time. Hence outcome measures not reported. | Posted | 1 year |
|
| |||||||||||||||||||
| Secondary | Percentage of Patients Who Achieve a Significant Clinical Reduction in Back Pain Defined as >50% Reduction in VAS Score With Stimulation Compared With no Stimulation | Efforts were made but the information is not accessible at this time. Hence outcome measures not reported. | Posted | 1 year |
|
|
Adverse events were collected from enrollment through end of study.
Efforts were made but the information is not accessible at this time. Hence adverse events not reported.
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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 | Subjects will undergo a temporary or permanent trial to assess their candidacy for placement of an implantable pulse generator. Those who demonstrate a significant clinical reduction in pain will be enrolled in the chronic study. Subjects will be followed for 12 months post implantation to assess the long-term effectiveness of the therapy. | 0 | 304 | 0 | 304 | 0 | 304 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Sciences | Boston Scientific | 6619494350 | roshini.jain@bsci.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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