Fibrin for Chronic Multi-level Discogenic Low Back Pain

Phase 2

• Conditions: Low Back Pain; Disc Degeneration; Radiculopathy; Annular Disc Tear; Disc Disease
• Interventions: Drug: Fibrin sealant

• Registration Number: NCT04621799
• Lead Sponsor: Pauza, Kevin, MD

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.

Study Timeline

• Study Start: 2018-06-11
• Status Verified: 2020-11
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Study First Posted: 2020-11-09
• Last Update Posted: 2020-11-09
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibrin Group	Fibrin sealant	Experimental: Non-Autologuos Fibrin (NAF) Subjects in the NAF arm received an injection of non-autologous fibrin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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).
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
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).
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).
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).
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).

Trial Locations

Locations (1)

Interventional Spine Specialist; 🇺🇸 Tyler, Texas, United States