Chronic low back pain (cLBP) remains one of the most prevalent and disabling conditions worldwide, significantly affecting the quality of life and productivity for millions of individuals. For those dealing with discogenic cLBP—pain caused by degeneration or damage to the intervertebral discs—the journey toward lasting relief is often frustrating and unsuccessful. Traditional treatment options frequently fall short, prompting a growing interest in regenerative medicine.
The objective of this study was to evaluate the safety and efficacy of a novel, pragmatic algorithm that both diagnoses and treats cLBP by first identifying annulus fibrosus tears (fissures) in the region of symptoms and then delivering targeted fibrin sealant therapy to support disc repair and functional recovery.
Limitations of Traditional Treatments
Surgical options such as spinal fusions and discectomies have long been used to manage disc-related pain. However, these procedures carry inherent risks and may inadvertently accelerate degeneration. Fusions can increase stress on adjacent discs, while discectomies may weaken the disc structure, making them less than ideal for long-term relief.
Regenerative techniques such as bone marrow aspirate concentrate (BMC) and platelet-rich plasma (PRP) injections offer more conservative alternatives. Still, they lack a crucial component—adhesive properties that enable the treatment to remain within the disc and target the damaged tissue. Without a way to stay in place, these therapies often fail to promote true disc healing.
Evaluating Fibrin Sealant as a Regenerative Option
Fibrin, a natural component of the body’s wound healing process, offers unique advantages as a regenerative therapy. As a bio-adhesive, fibrin can immediately bind to tears in the annulus fibrosus—the tough outer layer of the disc—helping to stabilize the structure and promote tissue regeneration. This property makes fibrin an ideal candidate for treating chronic discogenic pain in a minimally invasive way.
A recent study explored the use of intra-annular injections of allogeneic fibrin sealant to treat patients suffering from chronic low back pain, even after multiple failed interventions. The results are compelling and suggest a promising path forward for individuals living with this difficult condition.
Study Overview and Patient Population
This retrospective cohort study involved 827 patients who had suffered from chronic low back pain—with or without radiculopathy (leg pain due to nerve irritation)—for a minimum of six months. The average duration of symptoms before treatment was 11.2 years, highlighting the severity and chronicity of the condition in the study group.
Participants had already failed at least four invasive treatments, including PRP, BMC, epidural steroid injections, and radiofrequency neurotomies. Some had even undergone failed surgeries such as discectomies and spinal fusions. The mean patient age was 56, and the cohort included 70% men and 30% women.
To qualify, patients underwent MRI and radiographic evaluations to rule out other conditions like spinal fractures, malignancies, severe instability, or significant stenosis. Only those who met strict inclusion criteria were eligible for treatment.
Diagnostic and Treatment Process
The study utilized annulargrams, an imaging technique used during the procedure to identify annular tears within the disc. These diagnostic tools were performed concurrently with the fibrin injections, providing real-time guidance to ensure precise delivery.
Allogeneic fibrin sealant was then injected into the identified fissures in the annulus fibrosus using fluoroscopic imaging to guide placement. Because fibrin adheres directly to the tissue, it integrates with the disc and creates a scaffold for tissue repair.
This innovative approach combines diagnosis and treatment in a single session, improving efficiency and potentially reducing healthcare costs. Future research may examine the cost-effectiveness of this streamlined model.
Promising Patient Outcomes
The results of the study were highly encouraging. Significant improvement was observed at one, two, and three years after the procedure across multiple outcome measures, including the:
- Oswestry Disability Index (ODI)
- Visual Analog Scale (VAS)
- PROMIS® Physical and Mental Health Scores
At the 12-month follow-up, 50% of patients achieved the minimum clinically important difference (MCID) in the ODI score, indicating meaningful functional improvement. Importantly, these positive outcomes were consistent across age, gender, comorbidity, and prior treatment history.
Interestingly, patients who had previously undergone surgery saw even greater relative improvement than those who had not. This finding suggests that fibrin injections may offer an effective second-line treatment for patients who did not benefit from surgical interventions.
Safety and Adverse Events
No severe adverse events or infections were reported in the study, which is consistent with existing literature showing low complication rates from interventional spine procedures. Fibrin’s natural bio-compatibility may contribute to its favorable safety profile.
Given the high safety margin and promising results, fibrin sealant appears to be a well-tolerated and effective treatment option for patients with discogenic low back pain.
Study Limitations and Future Directions
Despite its promising outcomes, the study was not without limitations. It was a retrospective analysis of prospectively collected data, and it lacked a randomized control group. Participants acted as their own controls through pre- and post-treatment comparisons. Additionally, the voluntary nature of treatment selection may have introduced selection bias.
The gender imbalance (30% female, 70% male) also limits the generalizability of results. Future studies should aim for more gender-balanced samples to better understand how the treatment performs across populations.
Patient compliance with follow-up assessments decreased over time, which may have affected the consistency of long-term outcome data. Still, the data were independently collected and analyzed by statisticians using validated tools from the Regenerative Orthobiologics Registry, which adds credibility to the findings.
To strengthen the evidence base, future studies should include randomized controlled trials (RCTs), longer follow-up periods, broader patient populations, and comparative studies against other biologics like PRP and BMC.
A New Path Forward in Regenerative Spine Care
For patients who have struggled with years of chronic low back pain, intra-annular fibrin sealant offers new hope. Its unique adhesive properties allow it to bind securely within the disc, facilitating healing where other treatments have failed. Even in patients with extensive treatment histories, including failed surgeries, fibrin sealant injections demonstrated the ability to restore function and relieve pain.
This study highlights the regenerative potential of harnessing the body’s own healing mechanisms in a minimally invasive way. It also sets the stage for larger clinical trials that can solidify fibrin sealant’s place in the treatment landscape for discogenic cLBP.
Fibrin Sealant Injections: A Breakthrough in Regenerative Treatment for Chronic Discogenic Back Pain
Intra-annular injections of allogeneic fibrin sealant represent a safe, effective, and innovative approach to managing chronic discogenic low back pain and radiculopathy. With improvements documented across both physical and mental health outcomes—and a favorable safety profile—this treatment offers a compelling alternative for patients who have not responded to traditional therapies.
As the field of regenerative medicine continues to evolve, treatments like fibrin sealant provide not only physical relief—but also hope—for those whose lives have been disrupted by chronic back pain.
Source: Pauza K, Boachie-Adjei K, Nguyen JT, Hussey Iv F, Sutton J, Serwaa-Sarfo A, Ercole PM, Wright C, Murrell WD. 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. Pain Physician. 2024 Nov;27(8):537-553. PMID: 39621982.
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