(Burr Ridge, IL)—In what may be a landmark study, researchers report short-term pain relief with intradiscal steroid injections—a minimally-invasive, nonsurgical therapy—that could alleviate chronic lower back pain (CLBP) for millions of people worldwide. The findings are published in the February 2011 issue of The Spine Journal, an international multidisciplinary scientific journal of the North American Spine Society (NASS).
“If these results are independently reproducible, this study will be a major landmark in the treatment of persistent low back pain,” said Eugene J. Carragee, MD, editor in chief of The Spine Journal. In an accompanying editorial, Dr. Carragee acknowledges the fascinating, yet concerning results are likely to be considered highly controversial. “From an editorial perspective, it is strongly recommended that prior to general application of these isolated findings, a confirmatory trial should be carefully, independently and expeditiously performed.”
The study, “Intradiscal injection therapy for degenerative chronic discogenic low back pain with end plate Modic changes,” suggests that for patients with a particular clinical presentation of CLBP, an injection of a corticosteroid anti-inflammatory into the affected disc could measurably improve their pain and quality of life. The lead author of the study is Peng Cao, MD, PhD of the Shangai Institute of Traumatology and Orthopaedics at Jiao Tong University in Shanghai, China.
A total of 120 patients with positive discography and end plate Modic changes at a single level were enrolled in this study and allocated into Groups A and B, according to the types of Modic changes on MRI. Then, the patients in Groups A and B were randomized into three comparable subgroups with respect to gender, age, pain and percentage disability. Intradiscal injection of normal saline was performed in Subgroups A1 and B1, intradiscal injection of diprospan was performed in Subgroups A2 and B2, and intradiscal injection of a mixed solution of diprospan and songemile, an herbal extract, was performed in Subgroups A3 and B3. The clinical outcome of each patient was evaluated and recorded using the visual analog scale (VAS) and the Oswestry Disability Index (ODI) at three and six months after the procedure.
Neither VAS pain scores or ODI function scores of the patients within Group A had any improvement at three or six months after saline injection, but both of them improved significantly at the two time points after diprospan and diprospan+songemile injection, respectively. Meanwhile, the latter two injection protocols led to no significant difference in pain relief and functional recovery. Similar results were obtained in patients within Group B. Furthermore, no difference of the improvement of the VAS pain scores or ODI function scores was found between the patients within Group A and within Group B at different time points after various interventions.
The study’s authors conclude that “intradiscal injection of corticosteroids could be a short-term, efficient alternative for discogenic low back pain patients with end plate Modic changes on MRI who were still unwilling to accept surgical operation when conservative treatment failed.”
In an accompanying commentary, “Something is Amiss,” Robert D. Fraser, MBBS, MD, FRACS urges caution. While he applauds this line of research inquiry, Dr. Fraser questions the dramatic findings which are “so disparate from other randomized control trials on spine disorders.” He also expresses concern with the study’s infection prevention techniques, duration of the patients’ pain, and ultimately, the therapy’s safety in repeated, long-term use. He determines that “it would be quite inappropriate to develop treatment protocols based on this study.”
However, in another commentary, Connor O’Neill, MD finds interesting the authors’ identification of a discrete subgroup of CLBP patients for whom intradiscal steroid injections may be effective. While Dr. O’Neill expresses concern that much that is unknown about the study participants could affect therapeutic outcomes—such as work status, job type and insurance coverage—he is willing “to offer intradiscal steroids to CLBP patients with Modic changes but only if they are psychosocially intact, do not have other serious pain disorders, are not involved in the workers compensation system, and are bad enough that they are seriously considering spinal fusion.”
The Spine Journal is an international and multidisciplinary journal of the North American Spine Society (NASS). NASS is a multidisciplinary medical organization dedicated to fostering the highest quality, evidence-based and ethical spine care by promoting education, research and advocacy. NASS is comprised of more than 6,000 members from several disciplines including orthopedic surgery, neurosurgery, physiatry, neurology, radiology, anesthesiology, research, physical therapy and other spine care professionals. http://www.spine.org/