Discogenic Low Back Pain Registry
Study Details
Study Description
Brief Summary
Registry is to observe and trend patterns of care and outcomes for the standard of care treatments of discogenic chronic LBP.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The Discogenic Low Back Pain (LBP) Registry is intended to complement and integrate data collected in ongoing randomized-controlled clinical studies to aid in establishing payor coverage in the United States (US) for VIA Disc NP with real-world data. This registry will, in turn, further assist in establishing a health economics argument for use of VIA Disc NP in medical facilities for US payors and provide real-world data to support ongoing quality for care initiatives.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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VIA Disc NP Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment for discogenic low back pain. |
Biological: VIA Disc NP
VIA Disc NP - Allograft tissue injection
|
Non Surgical Management Patients receiving non surgical management (i.e., physical therapy, transforaminal epidural steroid injection, lifestyle modification, or surgical intervention) |
Drug: Transforaminal Epidural steroid injection
epidural injection of steroid into the affected area of low back pain
Behavioral: Lifestyle modification
physician instructed changes to patient's daily activities to alleviate low back pain
Other: Physical therapy
Physician ordered physical therapy and exercises to alleviate low back pain
|
Outcome Measures
Primary Outcome Measures
- Patient self-reporting of overall health [1, 3, 6, 12, 24, & 36 months]
Change in scores from Patient Reported Outcomes Measurement Information System (PROMIS-10). 10-item questionnaire used to assess general domains of health and function, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life.
- 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 low 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
- Employment Status [1, 3, 6, 12, 24, & 36 months]
Patient reported return to work - same or different capacity answers to employment questions will be assessed across time points and compared.
- Resource Utilization [1, 3, 6, 12, 24, & 36 months]
Patient reported assessment of healthcare and resources utilized questions to treat ongoing discogenic low back pain post treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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Understand and sign the informed consent form (as applicable)
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Discogenic Low Back pain diagnosis made and/or confirmed at participating site based on:
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Axial low back pain and discomfort
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Sitting intolerance
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Increased pain with bending forward, sustained hip flexion and compression
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Pain is less with lying down or hip extension
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Evidence of degenerated lumbar disc on MRI
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Minimum of six (6) months prior non-surgical management
Exclusion Criteria:
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Disc extrusions or sequestration
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Symptomatic spinal stenosis
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Spondylolsthesis of grade 2 or higher
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Lumbar spondylitis
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Vertebral compression fracture at any level
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Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy) Evidence of substance abuse or patients using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within 3 months prior to screening
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Evidence of mental instability (bipolar disorders, post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression); requiring new or any change in anti-depressants or anti-psychotic medications; or in opinion of the investigator is not a reliable candidate
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Discogenic Low Back Pain is due to worker's compensation and/or a personal injury case. Litigation is occurring or expected during study participation.
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Altered mental status or any language barriers that would prevent completion of the patient reported outcome surveys after the procedure.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Gateway Pain Solutions | Mesa | Arizona | United States | 85206 |
2 | Source Healthcare | Santa Monica | California | United States | 90403 |
3 | Interventional Pain Management | Walnut Creek | California | United States | 94598 |
4 | International Spine, Pain & Performance Center | Washington | District of Columbia | United States | 20006 |
5 | FAST MD | Tampa | Florida | United States | 33609 |
6 | Orthopaedic Research Foundation | Indianapolis | Indiana | United States | 46278 |
7 | Michigan Interventional Pain Center | Brownstown | Michigan | United States | 48183 |
8 | Insight Research Institute | Flint | Michigan | United States | 48507 |
9 | Forest Health | Ypsilanti | Michigan | United States | 48198 |
10 | Nevada Advanced Pain Specialists | Reno | Nevada | United States | 89511 |
11 | Ainsworth Institute of Pain Management | New York | New York | United States | 10022 |
12 | Premier Pain | Loveland | Ohio | United States | 45140 |
13 | Invictus Healthcare System | Tulsa | Oklahoma | United States | 74133 |
14 | Center for Interventional Pain Spine | Chadds Ford | Pennsylvania | United States | 19317 |
Sponsors and Collaborators
- VIVEX Biologics, Inc.
- Talosix
Investigators
- Principal Investigator: J Kenneth Burkus, MD, J Ken Burkus MD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VIV-001-020