Open AccessIntradiscal Injection of Fibrin Sealant for the Treatment of Symptomatic Lumbar Internal Disc Disruption: Results of a Prospective Multicenter Pilot Study with 24‐Month Follow‐Up
Author(s) -
Yin Way,
Pauza Kevin,
Olan Wayne J.,
Doerzbacher Jeff F.,
Thorne Kevin J.
Publication year - 2014
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/pme.12249
Subject(s) - medicine , visual analogue scale , low back pain , lumbar , prospective cohort study , magnetic resonance imaging , back pain , confidence interval , surgery , adverse effect , fibrin , anesthesia , radiology , alternative medicine , pathology , immunology
Objective Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. Design Prospective, nonrandomized F ood and D rug A dministration approved pilot study. Setting Three centers in the U nited S tates.Subjects Fifteen adults with chronic, single, or contiguous two‐level lumbar discogenic pain confirmed through meticulous provocation discography. Interventions Volume‐ and pressure‐controlled intradiscal delivery of BIOSTAT BIOLOGX ® F ibrin S ealant with the B iostat ® D elivery D evice into symptomatic lumbar disc(s). Outcome Measures Assessments 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 R oland‐ M orris D isability Q uestionnaire ( RMDQ ). Results Safety 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. Efficacy Mean 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. Conclusion Intradiscal injection of BIOSTAT BIOLOGX F ibrin S ealant with the B iostat D elivery D evice appears safe and may improve pain and function in selected patients with discogenic pain.