Intradiscal 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
| Autor: | Kevin J. Thorne, Way Yin, Jeff F. Doerzbacher, Kevin Pauza, Wayne J. Olan |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Spasm Discitis Adolescent Visual analogue scale Provocation test Discography Pilot Projects Fibrin Tissue Adhesive Injections Intralesional Disability Evaluation Young Adult Lumbar Surveys and Questionnaires medicine Humans Prospective Studies Aged Pain Measurement Lumbar Vertebrae medicine.diagnostic_test business.industry Magnetic resonance imaging General Medicine Middle Aged medicine.disease Low back pain Magnetic Resonance Imaging Surgery Radiography Anesthesiology and Pain Medicine Anesthesia Female Neurology (clinical) medicine.symptom business Low Back Pain muscle spasm Intervertebral Disc Displacement Follow-Up Studies |
| Zdroj: | Pain medicine (Malden, Mass.). 15(1) |
| ISSN: | 1526-4637 |
| Popis: | Objective Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. Design Prospective, nonrandomized Food and Drug Administration approved pilot study. Setting Three centers in the United States. 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(®) Fibrin Sealant with the Biostat(®) Delivery Device 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 Roland-Morris Disability Questionnaire (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 Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain. |
| Databáze: | OpenAIRE |
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