Diagnostic Tools and Outcomes of Using Fibrin to Seal Spinal Disc Tears

Paper: Long-term Investigation of Annulargrams and Intra-annular Fibrin to Treat Chronic Discogenic Low Back Pain and Radiculopathy: 1-, 2-, and 3-Year Outcome Comparisons of Patients with and without Prior Surgery

Authors: Kevin Pauza, Kwadwo Boachie-Adjei, Joseph T. Nguyen, Francis Hussey IV, Jacob Sutton, Akua Serwaa-Sarfo, Patrick M. Ercole, Carrie Wright, and William D. Murrell

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Chronic lower back pain is highly prevalent and difficult to treat, with many of the current, traditional treatment methods failing to provide relief to the pain. This study evaluated the authors’ method of the diagnosis of annulus fibrosis tears which cause chronic lower back pain as well as the treatment of such using a fibrin sealant, rather than one of the traditional treatment methods.

The study was a retrospective cohort study with prospectively reported patient outcomes. The study comprised of 827 patients who had chronic lower back pain for a least 6 months and who experienced failed attempted treatments for their pain. These failed treatments included procedures ranging between conservative methods such as physical therapy to invasive surgical procedures. Patients received an MRI of their spine 6 months prior to the procedure to screen for carcinoma, acute fracture, or severe vertebral canal or intervertebral foramen stenosis, patients with these pathologies were excluded from the study. Also excluded from the study were patients with spinal instability, spondylolisthesis that exceeded grade II and disc extrusions or non-contained disc herniations.

The AF tears were identified using an annulargram (as seen in the accompanying image), which is done at the same time as the procedure under local anaesthesia. The annulargram entailed fluoroscopic visualization of 4 spinal discs in the region of the patients’ pain. Tears were identified by injecting a contrasting dye into the posterior annulus, which would show the physicians the tear location and size. If an AF tear was identified, the tear was treated with the fibrin sealant.

The efficacy of the fibrin sealant treatment was measured in terms of patient physical function using the Oswestry Disability Index (ODI), back and leg pain using the Visual Analog Scale (VAS), quality of life using the EuroQOL score, mental and physical health using PROMIS®  GMH and GPH scores and patient satisfaction using the modified North American Spine Society (NASS) score. These outcomes were collected before the procedure and at 1, 3, 6-, 12-, 24- and 36-months post-procedure.

The average patient age was 54 years old and 30% of the patients were female. Of the study participants, 20% had undergone previous back surgery. Patients that had previous back surgery had slightly poorer outcomes than those that did not have back surgery, however, both groups of patients showed significant improvement over time. Patients showed improved outcomes for every outcome measure at all follow up points, with 50% of patients attaining the minimal clinically important differences (the outcome difference that a patient would define as important) for pain relief and physical function at 12 months. By 12 months, 69% of the patients were satisfied with the procedure. There were no serious adverse events or infections reported in this study.

A limitation of the study is that follow up rates for the outcomes for post-treatment are less than 50% from 3 months onwards.

The study showed that the fibrin sealant technique was an effective method for treating AF tears and relieving chronic lower back pain for up to three years.