An injectable hydrogel shown to greatly reduce chronic back pain caused by degenerative disc disease (DDD) has received FDA approval. The experimental hydrogel is injected directly into the spinal discs and significantly reduced pain felt by people with the condition, also proving to be safe to use over a six-month period.
While hydrogels have been used in the past, this will be the first time this gel has been used in humans and may provide the first effective treatment for DDD.
Spinal discs are biological cushions that lessen impacts and loads on the spine, acting as a shock absorber between vertebrae. As we age, the discs can begin to degrade, crack or tear, and the fluid inside may leak out. With no cushioning in those areas of the spine, chronic back pain can occur, and this is currently a leading cause of chronic back pain.
Treatment options are incredibly limited, with the most common options being physical therapy, strong painkillers, or extremely invasive surgery.
In the pursuit of a better option, researchers from Clinical Radiology of Oklahoma enrolled a sample of 20 patients with DDD and chronic back pain, asking each to rate their pain on a scale of 1 to 10. Each patient then underwent surgery in which doctors heated Hydrafil™ gel to become a thick liquid before injecting it into the damaged discs. The gel filled in the discs and adhered to the outer walls, allowing it to absorb impacts once more.
After six months, the results were extremely promising – all participants reported significantly lower back pain, from an average of 7.1/10 down to 2/10. They also responded by saying the back pain was having far less of an impact on their overall lives, improving their daily functioning.
“We really have no good treatments for degenerative disc disease, aside from conservative care,” said lead author Douglas P. Beall, chief of radiology services at Clinical Radiology of Oklahoma, in a statement.
“Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is appropriate for only a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can pop out of place if you’re not highly skilled in placing it.”
“Because this gel is injectable, it requires no incision, and it augments the whole disc, restoring its structural integrity, which nothing we have currently can do,” he continued.
The research is to be presented at the Society of Interventional Radiology Annual Scientific Meeting.