Fibrin for Chronic Multi-level Discogenic Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04621799
• Other study ID #: Regen_006-0120
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 11, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2020
• Source: Pauza, Kevin, MD
• Contact: Kevin Pauza, MD
• Phone: 239-317-3108
• Email: kevinpauza[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Annular Disc Tear
• Back Pain
• Disc Degeneration
• Disc Disease
• Intervertebral Disc Degeneration
• Low Back Pain
• Radiculopathy

Intervention

Drug:
• Fibrin sealant
The intra-annular delivery of non-autologous fibrin into the annulus

Locations

Country	Name	City	State
United States	Interventional Spine Specialist	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pauza, Kevin, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years
Secondary	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	Two Years
Secondary	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)	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years
Secondary	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).	Two Years