Back Pain, Back Pain, Low, Discogenic Pain
Conditions
Keywords
back pain
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.
Interventions
OTHERVIA Disc NP (HCT/P)
VIA Disc NP - Allograft tissue injection
Sponsors
VIVEX Biologics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Outcome results
None listed