VIA Disc NP Registry 3.0
- Conditions
- Discogenic PainBack PainBack Pain, Low
- Interventions
- Other: VIA Disc NP
- Registration Number
- NCT06345690
- 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
- 18 years of age or older
- Literate, able to speak and read English, and able to complete questionnaires independently
- Subject received a VIA Disc NP injection with 1 or more levels within 90 days of the baseline visit.
- Participant did not receive VIA Disc NP injection
- Participant is pregnant (self-reported, no special study pregnancy testing needed).
- Any contraindications as noted in the VIA Disc NP Instructions for Use
- Previous treatment with VIA Disc NP
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description VIA Disc NP VIA Disc NP Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
MD Pain
🇺🇸Englewood, Colorado, United States
The Orthopedic Research Foundation, Inc.
🇺🇸Fishers, Indiana, United States
Procura Pain & Spine
🇺🇸Shenandoah, Texas, United States
Mocek Spine
🇺🇸Little Rock, Arkansas, United States
Western Rockies Interventional Pain
🇺🇸Grand Junction, Colorado, United States
The Denver Spine & Pain Institute
🇺🇸Greenwood Village, Colorado, United States
Premier Spine and Pain Institute
🇺🇸Thornton, Colorado, United States
The Orthopedic Institute
🇺🇸Gainesville, Florida, United States
Raso Pain Center
🇺🇸Jupiter, Florida, United States
Interventional Spine Care of the Palm Beaches
🇺🇸West Palm Beach, Florida, United States
Horizon Clinical Research
🇺🇸Jasper, Georgia, United States
Interventional Pain Specialists - Pain Clinic
🇺🇸Opelousas, Louisiana, United States
Paradigm Health System
🇺🇸Slidell, Louisiana, United States
Premier Pain Solutions
🇺🇸Asheville, North Carolina, United States
Comprehensive Pain Consultants of the Carolinas
🇺🇸Hendersonville, North Carolina, United States
Carolinas Pain Center
🇺🇸Huntsville, North Carolina, United States
Crystal Coast Pain Management
🇺🇸New Bern, North Carolina, United States
Renew Pain Solutions
🇺🇸Greenville, South Carolina, United States
Corpus Chrisi Pain Medicine
🇺🇸Corpus Christi, Texas, United States
Advanced Spine and Pain Center
🇺🇸San Antonio, Texas, United States
Woodlands Pain Consultants
🇺🇸Spring, Texas, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States