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| Name | Class |
|---|---|
| Bright Research Partners | INDUSTRY |
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The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algovita Spinal Cord Stimulation system | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in targeted pain compared to baseline | Percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. | 6 Month Follow-up Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Percent reduction in targeted pain compared to baseline | Percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. | 1, 3, 12, 18, and 24 Month Follow-up Visits |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic, intractable pain of the trunk and/or limbs who are appropriate to receive SCS therapy and successfully complete a stimulation trial.
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| Name | Affiliation | Role |
|---|---|---|
| Ben Tranchina | Nuvectra | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Healthcare Pain Clinic Associates | Show Low | Arizona | 85901 | United States | ||
| Coastal Pain and Spinal Diagnostics |
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| Percent change in targeted pain intensity compared to baseline | Percent reduction or actual reduction from baseline in targeted pain intensity, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits |
| Change in disability compared to baseline | Change from baseline in disability as measured by Oswestry Disability Index (ODI). The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits |
| Change in quality of life compared to baseline | Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits |
| Willingness to undergo procedure again | To record the participants willingness to undergo the procedure again using a question (yes/no) if the participant would be willing to undergo the procedure again. | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits |
| Rate of device-related and/or procedure-related Adverse Events (AEs) | To record the rate of device-related and/or procedure-related Adverse Events (AEs). | From Implant through 24 Month Follow-up Visit |
| Rate of surgical intervention of the SCS system | To record the rate of surgical intervention of the SCS system. | From Implant through 24 Month Follow-up Visit |
| Carlsbad |
| California |
| 92009 |
| United States |
| Samaritan Center for Medical Research | Los Gatos | California | 95032 | United States |
| Restore Orthopedics and Spine Center | Orange | California | 92868 | United States |
| Vitamed Research | Rancho Mirage | California | 92270 | United States |
| Spine & Nerve Diagnostic Center | Roseville | California | 95661 | United States |
| Relieve Pain Center | San Diego | California | 92103 | United States |
| Nona Medical Arts | Orlando | Florida | 32827 | United States |
| South Florida Clinical Research | South Miami | Florida | 33143 | United States |
| Ephraim McDowell Regional Medical Center | Danville | Kentucky | 40422 | United States |
| Brigham and Women's Hospital | Chestnut Hill | Massachusetts | 02467 | United States |
| Nevada Advanced Pain Specialists | Reno | Nevada | 89511 | United States |
| Garden State Pain Control | Clifton | New Jersey | 07013 | United States |
| OMNI Pain and Precision Medicine | Utica | New York | 13502 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Pennsylvania Pain and Spine | Chalfont | Pennsylvania | 18914 | United States |
| Universitatksklinikum Dusseldorf | Düsseldorf | 40225 | Germany |
| NCN-Neurochirurgische Praxis Neuss | Neuss | 41460 | Germany |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |
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