Back Pain Clinical Trial
Official title:
VIA Disc NP Registry
NCT number | NCT04652687 |
Other study ID # | VIV-001-020 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | May 3, 2020 |
Est. completion date | March 5, 2024 |
Verified date | May 2024 |
Source | VIVEX Biologics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
Status | Terminated |
Enrollment | 83 |
Est. completion date | March 5, 2024 |
Est. primary completion date | March 5, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older - Understand and sign the informed consent form (as applicable) - VIA Disc NP injection is scheduled for 1 or more levels Exclusion Criteria: - VIA Disc NP injection is not performed |
Country | Name | City | State |
---|---|---|---|
United States | Premier Pain Solutions | Asheville | North Carolina |
United States | Michigan Interventional Pain Center | Brownstown | Michigan |
United States | Center for Interventional Pain Spine | Chadds Ford | Pennsylvania |
United States | Specialist in Pain Management | Chattanooga | Tennessee |
United States | Atlantic Coast Pain Management | Conway | South Carolina |
United States | MD Pain | Englewood | Colorado |
United States | Vertex Spine | Franklin | Tennessee |
United States | The Orthopedic Institute | Gainesville | Florida |
United States | Western Rockies Interventional Pain Specialists | Grand Junction | Colorado |
United States | The Denver Spine & Pain Institute | Greenwood Village | Colorado |
United States | Orthopaedic Research Foundation | Indianapolis | Indiana |
United States | Anesthesiology & Pain Consultants | Lafayette | Louisiana |
United States | Premier Pain | Loveland | Ohio |
United States | Gateway Pain Solutions | Mesa | Arizona |
United States | Southeastern Spine Institute | Mount Pleasant | South Carolina |
United States | Crystal Coast Pain Management | New Bern | North Carolina |
United States | Ainsworth Institute of Pain Management | New York | New York |
United States | Ortho Spine Surgery Institute | North Richland Hills | Texas |
United States | Interventional Pain Specialists | Opelousas | Louisiana |
United States | Southwest Florida Pain Center | Port Charlotte | Florida |
United States | Nevada Advanced Pain Specialists | Reno | Nevada |
United States | Advanced Spine and Pain Center | San Antonio | Texas |
United States | MD SpineCare and DC Medical Solutions | San Antonio | Texas |
United States | Source Healthcare | Santa Monica | California |
United States | The Sprintz Center for Pain | Shenandoah | Texas |
United States | FAST MD | Tampa | Florida |
United States | Florida Spine & Pain Specialists | Tampa | Florida |
United States | Invictus Healthcare System | Tulsa | Oklahoma |
United States | Interventional Pain Management | Walnut Creek | California |
United States | International Spine, Pain & Performance Center | Washington | District of Columbia |
United States | Florida Pain Medicine | Wesley Chapel | Florida |
United States | Forest Health | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
VIVEX Biologics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient self-reporting of daily function | Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain. | 1, 3, 6, 12, 24, & 36 months | |
Primary | Patient self-reported back pain | Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). | 1, 3, 6, 12, 24, & 36 months | |
Secondary | Patient self-reported mental health | Change in patient reported anxiety and depression scores. Four question scale used for patient self-reporting of anxiety and depression which ranges from 0-2 (normal), mild (3-5), moderate (6-8), and severe (9-12). | 1, 3, 6, 12, 24, & 36 months | |
Secondary | Resource Utilization | Patient reported assessment of healthcare and resources utilized questions to treat ongoing back pain post treatment. | 1, 3, 6, 12, 24, & 36 months |
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