Fibrin for Chronic Multi-level Discogenic Low Back Pain

Pauza, Kevin, MD400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Low Back Pain Disc Disease Disc Degeneration Radiculopathy Annular Disc Tear

Interventions

Fibrin sealantDRUG

The intra-annular delivery of non-autologous fibrin into the annulus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Interventional Spine Specialist

Tyler, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Central Contacts

Kevin Pauza, MD

CONTACT

239-317-3108 kevinpauza@gmail.com

Carrie Wright

CONTACT

239-317-3108 carrie@drkevinpauza.com

Data from ClinicalTrials.gov

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