The use of regenerative medicine has been expanding as its power to help heal patients has become increasingly apparent. However, the decision about what and who to treat with these therapeutic compounds can be tricky, especially given the variable and occasionally scarce data about certain applications. TOBI Alumni Faculty, Annu Navani has spearheaded a massive effort in collaboration with the American Society of Interventional Pain Physicians (ASIPP) to bring clarity to the use of biologic therapies for low back pain. Her publication represents the first ever effort to synthesize this research into straightforward recommendations for interventionalists interested in applying these therapies to their patients.
Low back pain accounts for a staggering proportion of disability both in the US and worldwide with US expenditures estimated to be higher than the amount spent on cancer, heart disease and diabetes combined. Additionally, many patients suffer chronically from what may start out as an acute issue. Several studies have indicated that as many as 25-60% of those presenting with low back pain will experience ongoing symptoms for a year or more.
While many treatments exist, few have made a significant impact on the prevalence of low back pain. These guidelines arose from a desire to synthesize the existing information on what could potentially be useful treatment for those suffering from this problem.
The guidelines provide useful background on the pathophysiology of pain in the lumbar spine, including extensive detail on disc disease, lumbar stenosis, post-surgery syndrome, facet pathology, SI joint pain, and myofascial pain related to soft tissues of the back. They also provide useful review of the evidence surrounding regenerative medicine compounds including platelet-rich plasma (PRP), mesenchymal stem cells (MSCs), and other novel biologic preparations including exosomes and alpha 2 macroglobulin. The authors then discuss credible mechanisms for how these compounds could address the underlying etiologies of lower back pain.
They then engage in an extensive and in-depth review of the available literature on these treatments. From this investigation, the authors were able to derive the following level of evidence statements for using regenerative therapy to address low back pain:
1. The evidence for biologic management of lumbar discogenic pain has been assessed as Level III of V for PRP and MSC therapy.
2. The evidence for management of lumbar facet joint disorders has been assessed as Level IV of V for PRP.
3. The evidence for management of low back and lower extremity pain with epidural biologic injections has been assessed as Level IV of V for PRP.
4. The evidence for biologic management of sacroiliac joint pain has been assessed as Level IV of V for PRP.
Finally, the guidelines cover a wide range of important topics for practitioners interested in using biologic treatments for lower back pain. The topics include discussions about how to regulate the industry, ethical considerations for development of and use of these treatment, clinical guidelines, and guidelines for safe and effective use of biologic therapies.
The paper is a truly monumental work of research that will doubtless help many practitioners provide higher quality and more effective care to their patients. We applaud Dr. Navani’s efforts and encourage all readers to look through these new guidelines to see where they might have practice-changing implications.To download or read the publication: Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines