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
VIA Disc NP - Allograft tissue injection
Sponsors
Study design
Eligibility
Inclusion criteria
1. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 2. 18 years of age or older 3. Literate, able to speak and read English, and able to complete questionnaires independently 4. Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.
Exclusion criteria
1. Participant did not receive VIA Disc NP injection 2. Participant is pregnant (self-reported, no special study pregnancy testing needed). 3. Any contraindications as noted in the VIA Disc NP Instructions for Use 4. Previous treatment with VIA Disc NP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | 1, 3, 6, & 12 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). |
| Oswestry Disability Index (ODI) | 1, 3, 6, & 12 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 Satisfaction | 1, 3, 6, & 12 months | Patient reported assessment of treatment regarding their experience with the procedure. Four different responses, which range from Not at all satisfied (worst) to Extremely Satisfied (best). |
| Frequency of Pain Medication Use | 1, 3, 6, & 12 months | Assesses the frequency and type of pain medication administered to participants at baseline and follow-up visits scheduled at 1, 3, 6, and 12 months. Data will be collected to track changes in pain medication usage over time. |
Countries
United States
Contacts
Sponsor - Vivex Biologics