A nonsurgical treatment that uses tissue allografting offers pain relief and improvement in function for people with chronically painful degenerative discs in their lower backs, according to research presented at RSNA 2021.
Discogenic back pain occurs when the discs, the fibrocartilaginous structures that act as cushions between the vertebrae of the spine, begin to degenerate. The process of degeneration can start at a relatively early age.
Yoon
“These are patients typically in their twenties, thirties and forties who have chronic lower back pain without associated sciatica,” said study lead author Edward Yoon, MD, interventional musculoskeletal radiologist at the Hospital for Special Surgery in New York City. “When we take a look on the MRI, we see that one or two of the discs are losing water.”
Water dessication causes the disc to lose height, affecting nerves in the area and leading to debilitating pain. Pain medication and physical therapy are common treatment options for the condition in its early stages. For chronic conditions, spinal fusion surgery is often the only option. The surgery, in which two or more vertebrae are permanently joined, only works about half of the time. It permanently reduces mobility in the fused area of the spine and can have other negative long-term effects.
Allografts Show Promise as Alternative Treatment
The new treatment alternative involves the introduction of an allograft, a tissue graft from a donor that consists of ground nucleus pulposus, the cells that make up the soft gelatinous central portion of the disc. The ground pulposus are mixed with water and more than 6 million viable cells from the vertebral endplate, the bone and cartilage structure that separates the vertebrae and the disc.
“The theory is that allografts help with the pain and the function by restoring the nutrient-rich environment within the disc as well as increasing its plumpness,” Dr. Yoon said.
As part of the Viable Allograft Supplemented Disc Regeneration Trial (VAST), Dr. Yoon and colleagues evaluated 218 subjects with painful discogenic low back pain from 15 U.S. sites. The researchers divided the patients into a treatment group, a non-surgical management group and a placebo control group.
Data on pain, function and adverse events was collected at baseline, and three more times over the next year. Structural outcomes were evaluated by X-rays and MRI at six and at 12 months.
At 12 months, the allograft patients saw clinically meaningful improvements in scores related to pain and function. More than three-quarters of subjects who received allografts responded to treatment and there were no persistently symptomatic adverse events.
“Patients with these allografts had significant pain reduction as well as functional improvement at the one-year follow-up,” Dr. Yoon said.
The results of the study, the first prospective, triple-arm, randomized and blinded study of its kind, suggest that disc tissue allograft may be a beneficial nonsurgical treatment for patients who have chronically painful lumbar degenerative discs.
“We’re providing an alternative therapy that can significantly reduce pain and improve functional outcome with just a simple injection,” Dr. Yoon said.
In response to a question from the audience, Dr. Yoon said that the best candidates for the procedure would be people ages 40 or younger who have single degenerative disc disease with axial lower back pain.
Dr. Yoon and his colleagues are analyzing data from the two-year follow-up and will release those results soon.
Access the presentation, "Intervertebral Disc Regeneration Techniques: Viable Allograft For Intervertebral Disc Supplementation - Viable Allograft Supplemented Disc Regeneration Trial (VAST)," (SSMK01-5) on demand at Meeting.RSNA.org.
