• Way Yin, Kevin Pauza, Wayne J Olan, Jeff F Doerzbacher, and Kevin J Thorne.
• Bellingham Spine Pain Specialists, Bellingham, Washington, USA.
• Pain Med. 2014 Jan 1;15(1):16-31.

ObjectiveAssess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.DesignProspective, nonrandomized Food and Drug Administration approved pilot study.SettingThree centers in the United States.SubjectsFifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography.InterventionsVolume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s).Outcome MeasuresAssessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ).ResultsSafety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product.EfficacyMean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively.ConclusionIntradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.Wiley Periodicals, Inc.

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