Annular Disc Tear, Disc Degeneration, Disc Disease, Low Back Pain, Radiculopathy
Conditions
Keywords
Non-autologous fibrin, Minimally Invasive, Injections, Intervertebral disc, Annulus Fibrosus, Sciatica
Brief summary
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
Detailed description
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.
Interventions
DRUGFibrin sealant
The intra-annular delivery of non-autologous fibrin into the annulus
Sponsors
Pauza, Kevin, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A prospective evaluation of a cohort of patients with a specific characteristic over time to see if they develop a particular endpoint or outcome based on a stated hypothesis
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram
Exclusion criteria
* Scoliosis greater than 20 degrees * Spondylolysis * Spondylolisthesis greater than Grade 1 * Disc extrusion * Disc herniations or bulges \> 4mm causing severe stenosis * Prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty) * Cauda equina syndrome * Active malignancy or tumor as source of symptoms * Evidence of prior lumbar vertebral body fracture or trauma * Foraminal stenosis at the affected levels resulting in severe thecal sac compression * Dynamic instability on lumbar flexion/extension radiographs * Positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection * Known bleeding disorder * Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure * Presence of ferromagnetic implants that would interfere with MRI evaluations * Active or pending workers' compensation claims or other litigation related to the condition. * Pregnant or plans to become pregnant over the course of study participation (2 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Two Years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for back pain | Two Years | 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). |
| Visual Analog Scale (VAS) for leg pain | Two Years | 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 |
| PROMIS Physical Health | Two Years | 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) |
| Numeric Rating Scale (NRS) | Two Years | 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). |
| North American Spine Society (NASS) for patient satisfaction | Two Years | 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). |
| EURO Quality of Life (EuroQol) | Two Years | 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). |
| PROMIS Mental Health | Two Years | 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). |
Countries
United States
Contacts
Primary ContactKevin Pauza, MD
Backup ContactCarrie Wright
Outcome results
None listed