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In adults with chronic low back pain, evidence is very uncertain regarding the effectiveness and harms of the intra-annular Discseel fibrin injection system. Data are limited to 1 pre-post study from a single clinician. In adults with chronic discogenic low back pain, fibrin intradiscal injection using the BIOSTAT BIOLOGX intradiscal system does not decrease pain intensity or pain interference. Serious adverse events and any adverse events are common with fibrin intradiscal injection and may not differ between fibrin and saline.
Neck and back pain are important health care issues, leading to more disability than any other medical condition. In response to a request from the Veterans Health Administration Office of Integrated Veteran Care Clinical Determinations Unit and Pain Management Opioid Safety and Prescription Drug Monitoring Program, we conducted a systematic review on the efficacy and safety of fibrin intervertebral injections.
We identified 4 records describing 2 interventions. Three records evaluated the BIOSTAT BIOLOGX system: 1 small single-site case series, a randomized trial on clinicaltrials.gov without published results, and a review article from a single site of the multi-site randomized trial. Contrary to a pilot study, the trial (N = 220) was stopped due to lack of efficacy. At 26 weeks, there was no difference in the primary outcome of "subject success based on a composite of a minimum 30% decrease in low back pain, 30% improvement in function, maintenance of neurological status, no secondary interventions, and no serious adverse events" of BIOSTAT BIOLOGX fibrin versus saline; point estimates for success favored saline. One uncontrolled, single-site case series (N = 827) evaluated the Discseel proprietary fibrin intervertebral injection system for low back pain compared with baseline up to 3 years after treatment. Outcomes included pain intensity, pain interference, quality of life, and serious adverse events. Evidence was insufficient for all outcomes.
Efficacy and Safety of Fibrin Intervertebral Injections for Back and Neck Pain: A Systematic Review - Management Brief
