2020 Abstract Pending Publication:

Evaluating the Safety and Efficacy of Fibrin to Treat Multi-level Chronic Discogenic Low Back Pain

BACKGROUND:

Chronic low back pain is the most common cause of disability worldwide, and to date, no surgical or non-surgical treatment has been shown to reliably provide relief in treating chronic low back pain. Lumbar discs are the most common cause of chronic low back pain, and so this investigation evaluates the safety and efficacy of using non-autologous fibrin, introduced intra-annularly, to treat annular defects causing chronic low back pain. Annulogram is a dynamic test, identifying annular defects and contrast flow patterns within the 22-25 annular layers. Annulograms possess greater sensitivity than does MRI in identifying annular defects, and this dynamic test is somewhat analogous to coronary arteriograms, another dynamic test initially fraught with skepticism before it’s widespread acceptance which changed the paradigm evaluating CAD. Favorable results of ongoing investigations suggest that annulograms will be a mainstay in treating spine pathology. Previous published in vivo investigations demonstrate fibrin’s ability to mechanically repair annular defects and stimulate new disc growth, returning all disc biochemical and mechanical properties to normal. This investigation evaluates the amalgam of refinements meant to improve clinical outcome.

PURPOSE:

To evaluate the safety and efficacy of intra-annular fibrin to treat chronic low back pain. Compared to many prior investigations, this investigation evaluates the amalgam of diagnostic and therapeutic refinements meant to improve patient outcomes, including: (1) Diagnostic Annulograms  used to identify annular defects; (2) Targeting fibrin to those  Annulus Fibrosus defects; and (3) Treating each disc in the region of symptoms. of Subjects were treated by the Principle Investigator, and subjects prospectively reported their outcome measures in the Regenerative Orthobiologics Registry (ROR). Outcome tools measured; pain, physical function, mental health, quality of life, satisfaction, and adverse events, to evaluate the safety and efficacy of intra-annular non-autologous fibrin in treating patients with moderate to severe chronic low back pain.  

STUDY DESIGN:

Prospectively reported outcome measures analyzed retrospectively in the ROR. 

PATIENT SAMPLE:

Subjects suffering from low back pain, with or without leg pain, for greater than six months duration, who failed prior treatments, including; intra-discal stem cell or precursor cell injections (BMAC), as well as intra-discal PRP, zygapophyseal joint (facet joint) “stem cell or PRP  injections,” physical therapy, fluoroscopically-guided transforaminal or interlaminar epidural injections of corticosteroid, radiofrequency neurotomy, or medial branch blocks to rule out posterior element pain. Several subjects failed to experience relief following surgical discectomy and fusion.

OUTCOME MEASURES:

VAS low back; VAS leg; Numeric Rating Scale (NRS); Bodily Pain; Estimated Utility Score; PROMIS Global Mental Health; Global Physical Health; NASS Patient Satisfaction Index Score; Oswestry Disability Index (ODI); and EuroQuol.

METHODS:

320 Subjects with chronic low back pain (LBP) who failed to experience relief following prior spine treatments underwent a screening lumbar MRI and x-ray. Patients without severe vertebral canal stenosis or spinal instability, as determined by lumbar MRI and lateral X-ray, respectively, were enrolled in this investigation. All subjects reported their pre-treatment outcome measures in the ROR, and then underwent diagnostic anulograms, with subsequent intra-annular injection of non-autologous fibrin to treat annular defects of all morphologically abnormal intervertebral discs in the region of symptomology. Subjects reported their pre- and post-treatment outcome measures beginning in 2017 to present, assessing; pain, physical function, mental health, quality of life, and patient satisfaction. 

RESULTS: 

Statistically significant improvement was realized in every outcome tool comparing baseline to; 3-months, 6-months, and 1-year post-treatment. No subject was lost to follow-up or withdrawn, and no subject experienced an adverse event. The results of the longitudinal analysis demonstrated statistically significant improvement in all outcomes measured.  Table ______ [js1] reports the findings of the multiple pairwise comparisons between each time point. The values in each square of the matrix are the Bonferroni-adjusted p-values for each pairwise comparison. 

CONCLUSIONS: 

Patients with chronic low back pain underwent diagnostic annulograms to identify disc annular defects, and those defects were repaired using intra-annular injection of non-autologous fibrin. Subjects prospectively reported statistically significant improvement of all outcomes at; 3, 6, and 12 months post-treatment, with no adverse events.