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Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
The objective of this study is to compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracept™ Intraosseous Nerve Ablation Systems | Subjects with pain treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracept™ Intraosseous Nerve Ablation | Device | Intracept™ Intraosseous Nerve Ablation for treatment of patients diagnosed with vertebrogenic pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disability (Oswestry Disability Index (ODI) from Baseline | The Oswestry Disability Index (ODI) is a validated questionnaire of pain-related disability with total score on a scale of 0 (no disability) to 100 (complete disability). Categories for ODI total score are 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound or exaggerating). The published minimally clinically important difference for change in ODI is 10 points. | 60-months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects are established patients in a medical practice who will receive intraosseous nerve ablation to treat vertebrogenic pain utilizing a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use according to standard of care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Yamano | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com | |
| Diane Keesey | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons, M.A. | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flagstaff Bone & Joint | Recruiting | Flagstaff | Arizona | 86001 | United States |
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| Innovative Pain and Wellness | Recruiting | Phoenix | Arizona | 85014 | United States |
|
| MarinHealth Spine Institute | Recruiting | Larkspur | California | 94939 | United States |
|
| The Spine Wellness Center in Westport | Recruiting | Westport | Connecticut | 06880 | United States |
|
| Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Orlando Regional Medical Center | Recruiting | Orlando | Florida | 32806 | United States |
|
| North Idaho Day Surgery, LLC | Active, not recruiting | Post Falls | Idaho | 83854 | United States |
| Illinois Bone and Joint Institute | Recruiting | Barrington | Illinois | 60010 | United States |
|
| Commonwealth Pain and Spine | Recruiting | Lexington | Kentucky | 40509 | United States |
|
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70115 | United States |
|
| iSpine Clinics | Recruiting | Maple Grove | Minnesota | 55369 | United States |
|
| New York Spine and Pain Specialists | Recruiting | Port Jefferson Station | New York | 11776 | United States |
|
| University of Rochester | Recruiting | Rochester | New York | 14618 | United States |
|
| Novant Health Spine Specialists | Recruiting | Bermuda Run | North Carolina | 27106 | United States |
|
| Pacific Sports and Spine | Active, not recruiting | Eugene | Oregon | 97404 | United States |
| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
|
| Cy-Pain and Spine | Recruiting | Houston | Texas | 77065 | United States |
|
| University of Utah Orthopaedic Center | Recruiting | Salt Lake City | Utah | 84108 | United States |
|
| ID | Term |
|---|---|
| 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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