A Phase 2/3 interventional study of Fibrin sealant in Low Back Pain, Disc Disease and Disc Degeneration, sponsored by Pauza, Kevin, MD. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-09.
Sponsored by Pauza, Kevin, MD · Phase 2/3, Interventional, and Treatment
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
The purpose of this study is to analyze data available in the PIs Regenerative Orthobiologics Registry (ROR) and corresponding patient charts that will either support or refute the efficacy of Intra-annular fibrin as treatment for moderate to severe low back pain. Additionally, we seek to retrospectively identify possible predisposing factors that are correlated with positive outcomes with respect to patient-reported pain and function.
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's planned enrollment of 400 is above the median of 60 across 261 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →This is the only study on the registry with Pauza, Kevin, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin
Drug: Fibrin sealant
The intra-annular delivery of non-autologous fibrin into the annulus
Also known as: Baxter Tisseel
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst).
Time frame: Two Years
Numeric Rating Scale (NRS)
The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst).
Time frame: Two Years
Visual Analog Scale (VAS) for back pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst).
Time frame: Two Years
Visual Analog Scale (VAS) for leg pain
When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (wors
Time frame: Two Years
PROMIS Physical Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best)
Time frame: Two Years
PROMIS Mental Health
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best).
Time frame: Two Years
North American Spine Society (NASS) for patient satisfaction
The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst).
Time frame: Two Years
EURO Quality of Life (EuroQol)
EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best).
Time frame: Two Years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Degeneration→