Trial results show slight efficacy of fibrin sealant in chronic lumbar pain management
ORLANDO, Fla. — A placebo outperformed a fibrin sealant treatment for chronic lumbar discogenic pain in a multicenter controlled trial, according to a presenter at the International Spine Intervention Society Annual Meeting, here, who said the fibrin sealant had some effect on the patients studied.
“Although fibrin sealant demonstrated some modest efficacy across individual, as well as composite and categorical outcomes, looking at the primary outcome criteria, intradiscal saline did as good or better,” Way Yin, MD, said.
The study was designed to assess the efficacy of Biostat Biologx Fibrin Sealant (Spinal Restoration Inc.; Austin, Texas) through a delivery device the company designed to treat adults with internal disc disruption. It included 220 patients randomized to receive the fibrin sealant or intradiscal saline as placebo who were followed up through 26 weeks.
Thirty-five percent of patients who received the fibrin sealant reported 50% or more improvement in VAS pain scores and 19.1% of patients in the sealant group reported a 75% or more improvement in pain at 26 weeks. In the control group, 40.7% of patients reported a 50% improvement in pain scores and 31.5% of patients reported a 75% or more improvement at the 26 week endpoint of the study, according to Yin.
“The findings do not demonstrate a superiority of intradiscal fibrin sealant over intradiscal saline,” he said. – by Robert Linnehan
Reference: Yin W. Results of a national multi-Center randomized placebo controlled trial of fibrin sealant for the treatment of chronic lumbar discogenic pain. Presented at: International Spine Intervention Society Annual Meeting; July 30-Aug. 3, 2014; Orlando, Fla.
Disclosure: Yin is a speaker, consultant, director, expert witness, or author for Symbion Health Care.