Fibrin for Chronic Multi-level Discogenic Low Back Pain

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Low Back Pain, Disc Disease, Disc Degeneration, Radiculopathy, Annular Disc Tear

In brief

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

Key facts

Study ID

NCT04621799

Run by

Pauza, Kevin, MD

People needed

400

Starts

2018-06-11

Expected to finish

2021-06-30

Last updated by the study team

2020-11-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram

You may not qualify if…

• 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)

Where it is running

• Interventional Spine Specialist — Tyler, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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