Fibrin for Chronic Multi-level Discogenic Low Back Pain
Unknown statusPhase 2, Phase 3NCT04621799
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
Study details
- Official title
- A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain
- Conditions
- Low Back Pain
- Disc Disease
- Disc Degeneration
- Radiculopathy
- Annular Disc Tear
- Interventions
- Drug: Fibrin sealant
- Sponsor
- Pauza, Kevin, MD
- Start date
- 2018-06-11
- Primary completion
- 2020-12-31
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04621799