VIA Disc NP Registry
- Conditions
- Back PainDiscogenic PainBack Pain, Low
- Interventions
- Other: VIA Disc NP (HCT/P)
- Registration Number
- NCT04652687
- Lead Sponsor
- VIVEX Biologics, Inc.
- Brief Summary
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
- Detailed Description
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
- 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
- VIA Disc NP injection is not performed
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VIA Disc NP VIA Disc NP (HCT/P) Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
- Primary Outcome Measures
Name Time Method Patient self-reporting of daily function 1, 3, 6, 12, 24, & 36 months Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain.
Patient self-reported back pain 1, 3, 6, 12, 24, & 36 months 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).
- Secondary Outcome Measures
Name Time Method Resource Utilization 1, 3, 6, 12, 24, & 36 months Patient reported assessment of healthcare and resources utilized questions to treat ongoing back pain post treatment.
Patient self-reported mental health 1, 3, 6, 12, 24, & 36 months 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).
Trial Locations
- Locations (32)
Orthopaedic Research Foundation
🇺🇸Indianapolis, Indiana, United States
Advanced Spine and Pain Center
🇺🇸San Antonio, Texas, United States
Gateway Pain Solutions
🇺🇸Mesa, Arizona, United States
Source Healthcare
🇺🇸Santa Monica, California, United States
MD Pain
🇺🇸Englewood, Colorado, United States
Interventional Pain Management
🇺🇸Walnut Creek, California, United States
Western Rockies Interventional Pain Specialists
🇺🇸Grand Junction, Colorado, United States
The Denver Spine & Pain Institute
🇺🇸Greenwood Village, Colorado, United States
Southwest Florida Pain Center
🇺🇸Port Charlotte, Florida, United States
International Spine, Pain & Performance Center
🇺🇸Washington, District of Columbia, United States
Florida Pain Medicine
🇺🇸Wesley Chapel, Florida, United States
Anesthesiology & Pain Consultants
🇺🇸Lafayette, Louisiana, United States
Interventional Pain Specialists
🇺🇸Opelousas, Louisiana, United States
Michigan Interventional Pain Center
🇺🇸Brownstown, Michigan, United States
Forest Health
🇺🇸Ypsilanti, Michigan, United States
Nevada Advanced Pain Specialists
🇺🇸Reno, Nevada, United States
Ainsworth Institute of Pain Management
🇺🇸New York, New York, United States
Crystal Coast Pain Management
🇺🇸New Bern, North Carolina, United States
Center for Interventional Pain Spine
🇺🇸Chadds Ford, Pennsylvania, United States
Premier Pain Solutions
🇺🇸Asheville, North Carolina, United States
Premier Pain
🇺🇸Loveland, Ohio, United States
Invictus Healthcare System
🇺🇸Tulsa, Oklahoma, United States
Atlantic Coast Pain Management
🇺🇸Conway, South Carolina, United States
Specialist in Pain Management
🇺🇸Chattanooga, Tennessee, United States
Southeastern Spine Institute
🇺🇸Mount Pleasant, South Carolina, United States
Ortho Spine Surgery Institute
🇺🇸North Richland Hills, Texas, United States
Vertex Spine
🇺🇸Franklin, Tennessee, United States
MD SpineCare and DC Medical Solutions
🇺🇸San Antonio, Texas, 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
The Orthopedic Institute
🇺🇸Gainesville, Florida, United States